The American Journal of Surgery (2014) 208, 485-493
Review
Standardized measurement of quality of life after incisional hernia repair: a systematic review Kristian K. Jensen, M.D.*, Nadia A. Henriksen, M.D., Ph.D., Henrik Harling, M.D., M.Sc. Digestive Disease Center, Bispebjerg Hospital, University of Copenhagen, Bispebjerg Bakke 23, 2400 Copenhagen NV, Denmark
KEYWORDS: Quality of life; Incisional hernia; Hernia; Pain; Questionnaire; Patient-reported outcome
Abstract BACKGROUND: Recent improvements in incisional hernia repair have led to lower rates of recurrence. As a consequence, increasing attention has been paid to patient-reported outcomes after surgery. However, there is no consensus on how to measure patients’ quality of life after incisional hernia repair. The aim of this systematic review was to analyze existing standardized methods to measure quality of life after incisional hernia repair. DATA SOURCES: A PubMed and Embase search was carried out together with a cross-reference search of eligible papers, giving a total of 26 included studies. CONCLUSIONS: Different standardized methods for measurement of quality of life after incisional hernia repair are available, but no consensus on the optimal method, timing, or length of follow-up exist. International guidelines could help standardization, enabling better comparison between studies. Ó 2014 Elsevier Inc. All rights reserved.
Incisional hernia is a common complication after abdominal surgery, with reported incidences varying from 5% to 20%.1,2 In recent years, the surgery for incisional hernias has undergone a tremendous development with the introduction of new prosthetic material, laparoscopic methods, and component separation.3 This has led to an overall reduction in recurrence rates,4 and thus an increased attention has been directed toward other outcomes such as quality of life. Several factors may influence quality of life after incisional hernia repair such as pain, mobility
The authors declare no conflicts of interest. * Corresponding author. Tel.: 145-531-2201; fax: 145-3531-2891. E-mail address: [email protected] Manuscript received December 16, 2013; revised manuscript April 2, 2014 0002-9610/$ - see front matter Ó 2014 Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.amjsurg.2014.04.004
impairment, cosmetics, and length of convalescence. Besides, patient-reported outcome results are not only important to the patient, but also a factor highly relevant in the ongoing cost-effectiveness debate.5 The purpose of this study was to review the existing literature examining quality of life by standardized methods after incisional hernia repair.
Methods A PubMed and EMBASE search from January 1980 to November 2013 was carried out with the search terms ‘‘incisional hernia AND quality of life’’ combined with the Medical Subject Headings terms ‘‘pain,’’ ‘‘pain measurement,’’ ‘‘questionnaires,’’ and ‘‘hernia, ventral.’’ Filter options selected were publication type ‘‘articles’’ and
486
The American Journal of Surgery, Vol 208, No 3, September 2014
language ‘‘English.’’ Inclusion criteria were studies that used a standardized method to examine quality of life in patients who had undergone incisional hernia repair. Studies reporting quality of life by nonstandardized methods were excluded, and pain assessment tools were not part of the inclusion criteria. Abstracts, case reports, and letters to the editor were not included.
Results A total of 26 studies were included (Fig. 1) reporting quality of life by a standardized method after incisional hernia repair (Table 1). The timing of quality of life assessments varied from the first postoperative day to 5.6 years after surgery. A preoperative quality of life assessment was performed in 16 of the 26 studies (62 %). Eight different quality of life measurement methods were used and in 2 studies 2 different methods were used (Table 2).
Short-Form 36 The most common method for measuring quality of life was the Short-Form 36, which was used in 14 studies. Short-Form 36 was originally derived from the Medical
Figure 1
Outcome Study and is a health survey instrument comprised of 36 items, which assess 8 different health concepts (physical functioning, role physical, bodily pain, general health perceptions, vitality, social functioning, role emotional, and mental health) and summarizes into 2 main outcomes: physical and mental health score.6 It takes 7 to 10 minutes for a patient to self-administer6 and in general, the Short-Form 36 is the most frequently used quality of life assessment tool.7 The Short-Form 36 is neither disease- nor treatment specific, and therefore not restricted to surgical patients. Five studies reported quality of life after open mesh repair. Three studies comparing different types of meshes found no differences in quality of life at 6 and 24 months follow-up, respectively.8–10 Tollens et al11 reported a longterm follow-up of 4 years of 135 patients treated with sublay mesh repair, of whom 18 patients had recurrent incisional hernias. The main finding in this study was that hernia recurrence had a significantly negative effect on quality of life with regard to both physical functioning and general health, as compared with no recurrence. One study examined quality of life in 69 patients treated for an incisional hernia with onlay mesh repair12 and after 64 months of follow-up, the quality of life was comparable with a matched control group of patients without hernia.
Literature search flow chart.
Studies assessing quality of life by standardized methods after incisional hernia repair
Reference
n
Procedure
Preoperative assessment
NS
QOL assessment
Results
Yes
2 and 12 months postoperative
15D
Laparoscopic or open mesh repair
Yes
1, 6, and 12 months postoperative
CCS
Open component separation or standard open mesh repair Laparoscopic or open repair
Yes
,1 month and 6– 12 months postoperative 1, 6, 12, and 24 months postoperative
CCS
Improved QOL after surgery (hernia repair, fundoplication, cholecystectomy, and bowel resection) Laparoscopic repair is associated with decreased QOL in the short term compared with open Similar QOL outcomes with the 2 techniques
Open mesh or laparoscopic repair
Yes
2 weeks, 4 weeks, and 6 months postoperative
CCS
84
Laparoscopic or open mesh repair
No
EuroQol-5D
Marchesi et al32
41
No
1, 2, 3, 7, 15 days, and 1, 3, 12 months postoperative 1 month postoperative
Korenkov et al31
160
No
1 year postoperative
No
20
Colavita et al25
710
Klima et al28
228
Wormer et al26
865
Tsirline et al27
512
Asencio et al37
Ra¨sa¨nen et al
No
Paul et al30
88
Open and laparoscopic repair Suture repair, autodermal skin graft, or onlay mesh repair Open suture repair
Uranues et al33
85
Laparoscopic mesh repair
Yes
2 years postoperative
Krpata et al34
88
Yes
Canziani et al23
40
Open and laparoscopic repair Open mesh fibrin glue repair Sublay lightweight composite or polypropylene mesh repair
2 weeks, 4 weeks, and 6 months postoperative 1 year postoperative
Conze et al8
165
Yes Yes
CCS
Patients with large defect area and transverse defect width have higher odds of pain postoperatively Preoperative pain is a predictor of postoperative pain. Most patients experience resolution of symptoms after 6 months No difference in QOL in regard to technique
Gastrointestinal Quality of Life Index Gastrointestinal Quality of Life Index
No difference in QOL when comparing laparoscopic and open repair No difference in QOL regarding choice of technique
5.7 years postoperative (mean)
Gastrointestinal Quality of Life Index Gastrointestinal Quality of Life Index HerQLes
Patients who underwent suture repair had impaired physical function compared with healthy individuals Improved QOL at follow-up
21 days, 4, 12, and 24 months
SF-12 SF-36
Quality of life and incisional hernia
Follow-up
38
K.K. Jensen et al.
Table 1
Improved QOL after hernia repair Reduced pain and physical component score after surgery No significant difference in outcomes
(continued on next page)
487
488
Table 1
(continued )
Reference
n 9
24
Mussack et al13
48
Tollens et al11
18
Ladurner et al
Itani et al14
Procedure Open sublay repair with light or heavyweight mesh Laparoscopic or open sublay mesh repair Open sublay mesh repair
Preoperative assessment
QOL assessment
Results
No
112 or 75 months postoperative
SF-36
No difference in QOL regarding type of mesh
Yes
16 or 28 months postoperative 49 months postoperative (mean) 2 weeks, 8 weeks, and 12 months postoperative
SF-36
No differences in long-term QOL between open and laparoscopic repair Hernia recurrence has a negative effect on QOL Improved QOL after surgery, no differences between open and laparoscopic repair. VAS: mean worst pain score was lower in laparoscopic group Improved QOL at follow-up. No difference in QOL between the 2 groups Significantly affected QOL up to 6 months after surgery Sutures and tackers group had higher VAS scores after 3 months, similar QOL
No
SF-36 SF-36
146
Open mesh or laparoscopic repair
Yes
Bansal et al18
50
Laparoscopic mesh repair with tackers or sutures
Yes
3 months postoperative
SF-36
Eriksen et al17
35
Laparoscopic mesh repair
Yes
SF-36
Muysoms et al20
76
Yes
Rogmark et al16
133
Wassenaar et al19
199
Laparoscopic repair with double crown or transfacial sutures and one row of tackers Laparoscopic repair or open sublay mesh repair Laparoscopic repair: absorbable sutures with tacks, double crown, or nonabsorbable sutures Open sublay nonabsorbable/ absorbable mesh Various incisional hernia repairs
30 days and 6 months postoperative 3 months postoperative
Rickert et al10
80
Snyder et al21
361
Hope et al15
56
Poelman et al12
69
Laparoscopic or open mesh repair Open onlay mesh repair
Yes
SF-36
Yes
1.5, 3, 4, and 6 weeks postoperative 3 months postoperative
SF-36
Laparoscopic repair leads to better physical function No difference in VAS or QOL in regard to fixation technique
SF-36
No
21 days and 6 months
SF-36
Similar outcomes with 2 different meshes
No
56–62 (median)
SF-36
Yes
At least 6 months
SF-36 and CCS
No
64 months (mean)
SF-36 and Karnofsky Performance Status Scale
Repair technique has no independent effect on patient satisfaction, chronic pain, or QOL Improved QOL with laparoscopic repair compared with open QOL comparable with matched controls. Karnofsky Performance Status Scale score: patients had some signs of disease
CCS 5 Carolinas Comfort Scale; HerQLes 5 Hernia-Related Quality-of-Life Survey; NS 5 not stated; QOL 5 quality of life; SF-12 5 Short-Form 12; SF-36 5 Short-Form 36; VAS 5 Visual Analogue Scale.
The American Journal of Surgery, Vol 208, No 3, September 2014
Follow-up
K.K. Jensen et al.
Standardized questionnaires used to assess quality of life after incisional hernia repair
Name
Times used
Hernia specific
No. of questions
Output
Physical components
Mental components
Short-Form 36
14
No
36
Physical and mental health summary score Score of 0: 100
Physical functioning, role limitations caused by physical health problems, energy/fatigue, and pain
Short-Form 12
1
No
12
Physical and mental health summary score Score of 0: 100
Physical functioning, role limitations caused by physical health problems, energy/fatigue, and pain
Carolinas Comfort Scale
5
Yes
23
Score of 0: 115
Gastrointestinal Quality of Life Index
4
No
36
Score of 0: 144
EuroQol-5D
1
No
5
Karnofsky Performance Status Scale 15D
1
No
1
Pain, movement limitation, and mesh sensation for 8 different daily activities Physical role, large bowel function, upper gastrointestinal tract function, and meteorism Mobility, self-care, usual activities, and pain/discomfort None
Role limitations caused by emotional problems, social functioning, emotional well-being, and general health perceptions Role limitations caused by emotional problems, social functioning, emotional well-being, and general health perceptions None
1
No
15
Score of 0: 1 (being deaddno problems on any dimension)
Hernia-Related Quality-ofLife Survey
1
Yes
12
Score of 0: 100
Score of 0: 1 (being deaddperfect health) Decimal score of 0: 100
Breathing, speech, vision, mobility, usual activities, hearing, eating, elimination, discomfort, and symptoms Specific questions on core functioning and its effect on quality of life and abdominal wall function, concerning both physical and mental components
Quality of life and incisional hernia
Table 2
Emotional role
Anxiety/depression, and a visual analog health perception scale Measure of self-perceived health status Mental function, sleeping, distress, sexual activity, vitality, and depression None
489
490
The American Journal of Surgery, Vol 208, No 3, September 2014
Short-Form 36 has been used to assess quality of life after laparoscopic incisional hernia repair in 9 studies. No difference in quality of life after laparoscopic or open sublay repair was found in 2 studies, but quality of life after hernia repair was lower than that of healthy controls.13,14 In contrast, Hope et al15 found that laparoscopic ventral or incisional hernia repair resulted in a significant improvement in quality of life compared with open sublay mesh repair. In this study, both Short-Form 36 and the Carolinas Comfort Scale (described below) were used to assess quality of life, both supporting the superiority of the laparoscopic technique. Somewhat similar findings were reported in a study comparing laparoscopic and open sublay mesh repair in 133 patients.16 Short-term physical functioning was significantly improved in patients treated with laparoscopic approach compared with open repair, although no difference was found in general health. One study assessed quality of life in laparoscopic repair employing double-crown titanium tacks, and reported decreased quality of life in 3 domains (role physical, bodily pain and physical component scale) 1 month postoperative. However, the findings were normalized after 6 months when overall quality of life was comparable with healthy individuals.17 Three studies compared quality of life measured by Short-Form 36 after laparoscopic incisional hernia repair with different mesh fixation techniques and found no difference in overall quality of life,18–20 although a decrease in physical functioning and role limitations because of emotional problems was found after application of tackers with the double-crown technique.19 Finally, Snyder et al21 reported that the use of mesh or suture for incisional hernia repair has no influence on quality of life measured by Short-Form 36 after 5 years.
The Short-Form 12 The Short-Form 12 is a shorter version of the aforementioned Short-Form 36 that provides only a physical and mental component. It has been shown to give results comparable with Short-Form 36, with far less respondent burden.22 One study has used Short-Form 12 to assess changes in quality of life after sutureless mesh fibrin glue incisional hernia repair. It was observed that this technique led to an improved quality of life in the physical component score, while the mental component score was unaffected.23
Carolinas Comfort Scale Five studies analyzed quality of life after incisional hernia repair with the Carolinas Comfort Scale method, which is a 23-item questionnaire measuring severity of pain, sensation, and mobility impairment from an implanted mesh in 8 different categories.24 It is a herniaspecific questionnaire aiming on patients treated with a mesh. In addition to the aforementioned study,15 3 other studies assessed quality of life by the use of Carolinas Comfort Scale. Two studies originating from the
International Hernia Mesh Registry analyzed quality of life after ventral hernia repair by open and laparoscopic approach, using various techniques.25,26 Both incisional and primary ventral hernias were included in both studies. One reported that laparoscopic repair was associated with a decrease in quality of life (discomfort, activity limitation, and overall) after 1 month compared with open repair, but no long-term difference was found.25 Another study concluded that large defect width and total defect area were factors associated with decreased short-term quality of life in both laparoscopic and open incisional hernia repair.26 No difference was found at long-term follow-up. Tsirline et al27 used the Carolinas Comfort Scale to analyze predictors for postoperative pain after open mesh and laparoscopic repair. It was reported that preoperative pain was the strongest predictor for postoperative pain, but in most cases pain had ceased at 6 months of follow-up. One study compared quality of life after open component separation incisional hernia repair and open mesh repair.28 Patients treated with the 2 different techniques had comparable hernia dimensions and comparable quality of life was reported.
The Gastrointestinal Quality of Life Index A third method of measuring quality of life after incisional hernia repair is the Gastrointestinal Quality of Life Index, which is a disease-specific questionnaire designed for patients with gastrointestinal disorders.29 The questionnaire is comprised of 36 items each with 5 response categories. Together they yield a total quality of life score ranging from 0 to 144. One study used Gastrointestinal Quality of Life Index to examine long-term quality of life after open suture repair and found an overall decreased quality of life in patients treated for incisional hernia compared with healthy people30 and hernia recurrence did not influence the quality of life. Similar results were found when comparing Gastrointestinal Quality of Life Index-measured quality of life after either suture repair; mesh repair or autodermal skin graft repair in 160 patients with incisional hernias.31 After at least 9 months of follow-up, no differences in quality of life were found. Marchesi et al32 used the Gastrointestinal Quality of Life Index to compare laparoscopic and open mesh repair in 41 patients, also reporting no difference in quality of life. Finally, one study used the Gastrointestinal Quality of Life Index to assess changes in quality of life after laparoscopic incisional hernia repair.33 An improvement in the total quality of life and the domain’s emotional function, physical function, and symptoms were reported when comparing scores before and 2 years after surgery.
Hernia-Related Quality-of-Life Survey The Hernia-Related Quality-of-Life Survey is a herniaspecific quality of life assessment tool, consisting of 12 items that patients score from 1 to 6.34 One study has used Hernia-Related Quality-of-Life Survey to assess quality of
K.K. Jensen et al.
Quality of life and incisional hernia
life in patients undergoing open mesh or laparoscopic repair for primary and incisional hernia, reporting improved quality of life after 4 weeks but no further improvement after 6 months.34
Karnofsky Performance Status Scale Karnofsky Performance Status Scale is a measure of functional performance on a scale from 0 to 100. A score of 100 indicates that the patient can fully function and perform all activities of daily life with no evidence of disease, while a score of 0 is death. The scale was originally developed for evaluation in cancer patients, but has proved a valid tool in the assessment of patients with a chronic disease.35 The Karnofsky Performance Status Scale has been used in one previously mentioned study.12 In this study of onlay mesh repair, the Karnofsky Performance Status Scale score indicated that activities could be performed with effort and that patients had some signs of disease, indicating that the Karnofsky Performance Status Scale did detect some degree of decreased quality of life that was not detected by Short-Form 36.
EuroQol The EuroQol is a health-related quality of life scale, which consists of 5 questions concerning usual activity, self-care, mobility, pain or discomfort, and anxiety or depression. After the patient has answered these questions, a value between 0 and 1 is calculated, 0 being ‘‘death’’ and 1 ‘‘perfect health.’’36 The EuroQol has been used to compare laparoscopic and/or open inlay or onlay mesh repair of incisional hernia, and no differences in quality of life after 1 year of follow-up were reported.37 However, quality of life was decreased initially after surgery but improved until 1 year postoperatively.
15D Finally, one study analyses quality of life after various surgical procedures, including open incisional hernia repair with and without mesh (n 5 20), using the 15D questionnaire.38 The 15D is a generic, 15-dimensional, standardized questionnaire, which describe 15 different dimensions: breathing, mental function, speech, vision, mobility, usual activities, vitality, hearing, eating, elimination, sleeping, distress, discomfort and symptoms, sexual activity, and depression. Each dimension is stratified into 5 levels and transforms into a total score ranging from 0 to 1.39 In this study, no difference in quality of life was found when comparing preoperative status with follow-up results at 2 and 12 months.
Comments Eight different standardized methods of measuring healthrelated quality of life after incisional hernia repair were identified in the current review. Two methods were hernia specific, while one was specific for gastrointestinal disorders.
491 The most common questionnaire was the Short-Form 36, which is thoroughly validated and widely used.40 For these reasons the Short-Form 36 scores are easy to compare with other studies, which is desirable for a number of reasons. The main disadvantage of Short-Form 36 for evaluation of any surgical procedure is that it is generic and not disease specific and therefore prone to be affected by factors not associated with surgery.41 This also applies to the other generic questionnaires described in this review: Short-Form 12, EuroQol, Karnofsky Performance Status Scale, and 15D. Especially the Karnofsky Performance Status Scale, which was originally developed for evaluating cancer patients before initiation of chemotherapy, seems misplaced in the evaluation of a surgical procedure. While the disease-specific Gastrointestinal Quality of Life Index may be more relevant when assessing quality of life after incisional hernia repair, it too has its limitations, as subscales such as digestion and defecation are not affected by an incisional hernia. A more specific evaluation of quality of life in patients treated for an incisional hernia is possible with Hernia-Related Quality-of-Life Survey or Carolinas Comfort Scale, which to our knowledge are the only of their kind. Reliability and validity studies of the Carolinas Comfort Scale compared with Short-Form 36 has been done by the authors behind the Carolinas Comfort Scale, claiming that it is superior to Short-Form 36 when studying quality of life in patients undergoing surgical hernia repair.24 Carolinas Comfort Scale may be best suited for relatively symptomatic patients,42 but it is still a highly specific and relevant questionnaire when examining changes in quality of life related to a single procedure. The importance of a diseasespecific quality of life questionnaire is underlined by the fact that other conditions such as depression play a significant role when using generic questionnaires.43 Equal to Carolinas Comfort Scale, Hernia-Related Quality-of-Life Survey has proved its validity in a single study,34 but the value of this questionnaire awaits more studies. An important question when examining quality of life after surgical procedures is when to do the follow-up. To examine the impact of surgery, an assessment must be done pre- and postoperatively. Only half of the studies included a preoperative quality of life assessment. Furthermore, it remains unclear as to how long after incisional hernia repair the optimal assessment should be undertaken. In this review, several studies reported a decreased quality of life immediately after surgery, which returned to the preoperative level or higher subsequently. In orthopedic surgery, a recent review concluded that a follow-up of 12 months is desirable when assessing quality of life after hip and knee replacement,44 but of course this recommendation may be of little relevance for hernia surgery. Because no consensus on the method of measuring quality of life after incisional hernia repair exists, results are seldom comparable. Furthermore, the length of follow-up is infrequently comparable, which complicates comparisons even more. Another important issue when evaluating quality of life after incisional hernia repair is, which control group to use.
492
The American Journal of Surgery, Vol 208, No 3, September 2014
Several studies compared postoperative quality of life after incisional hernia repair with a group of healthy controls not having hernias and not undergoing surgery.12–14 One may argue that this comparison is irrelevant. To the best of our knowledge, there are no randomized controlled trials comparing quality of life in symptomatic incisional hernia patients randomized to surgery or watchful waiting strategy, meaning that the true impact of incisional hernia surgery on quality of life is in fact unknown. Other ways of measuring subjective outcomes of incisional hernia repair are found in the literature. In 9 of the included studies in this review, the quality of life questionnaire was combined with the Visual Analogue Scale for assessment of pain. The Visual Analogue Scale is a visual scale of 100 mm, ranging from 0 (no pain) to 100 (pain as bad as it could be), which has been used for more than a quarter of a century.45 Although the Visual Analogue Scale quantifies the pain a patient experiences, this is only one of the factors of overall quality of life after surgery. Another contributing factor to the overall quality of life is the patients’ self-perception, examined by the Body Image Questionnaire. The Body Image Questionnaire has been used to assess how patients with incisional hernias perceive their body image, finding that body image scores are significantly lower in patients with incisional hernias compared with healthy persons.46 In conclusion, there are several standardized methods for examining quality of life after incisional hernia repair, both generic and disease specific. Presently, however, no consensus on either the optimal method or timing of the measurement exists, calling for international guidelines on this topic, to enable comparison across the different studies. The authors of this review consider a combination of the existing methods ideal, providing a questionnaire assessing both disease-specific and generic aspects of quality of life. Thus a combination of Short-Form 36 and Hernia-Related Quality-of-Life Survey or Carolinas Comfort Scale presently should be the optimal method for quality of life assessment.
References 1. Millbourn D, Cengiz Y, Israelsson LA. Effect of stitch length on wound complications after closure of midline incisions: a randomized controlled trial. Arch Surg 2009;144:1056–9. 2. Mudge M, Hughes LE. Incisional hernia: a 10 year prospective study of incidence and attitudes. Br J Surg 1985;72:70–1. 3. Ramirez OM, Ruas E, Dellon AL. ‘‘Components separation’’ method for closure of abdominal-wall defects: an anatomic and clinical study. Plast Reconstr Surg 1990;86:519–26. 4. Luijendijk RW, Hop WC, van den Tol MP, et al. A comparison of suture repair with mesh repair for incisional hernia. N Engl J Med 2000; 343:392–8. 5. Coronini-Cronberg S, Appleby J, Thompson J. Application of patientreported outcome measures (PROMs) data to estimate cost-effectiveness of hernia surgery in England. J R Soc Med 2013;106:278–87. 6. Hays RD, Morales LS. The RAND-36 measure of health-related quality of life. Ann Med 2001;33:350–7. 7. Coons SJ, Rao S, Keininger DL, et al. A comparative review of generic quality-of-life instruments. Pharmacoeconomics 2000;17:13–35.
8. Conze J, Kingsnorth AN, Flament JB, et al. Randomized clinical trial comparing lightweight composite mesh with polyester or polypropylene mesh for incisional hernia repair. Br J Surg 2005;92:1488–93. 9. Ladurner R, Chiapponi C, Linhuber Q, et al. Long term outcome and quality of life after open incisional hernia repairdlight versus heavy weight meshes. BMC Surg 2011;11:25. 10. Rickert A, Kienle P, Kuthe A, et al. A randomised, multi-centre, prospective, observer and patient blind study to evaluate a non-absorbable polypropylene mesh vs. a partly absorbable mesh in incisional hernia repair. Langenbecks Arch Surg 2012;397:1225–34. 11. Tollens T, Den Hondt M, Devroe K, et al. Retrospective analysis of umbilical, epigastric, and small incisional hernia repair using the VentralexÔ hernia patch. Hernia 2011;15:531–40. 12. Poelman MM, Schellekens JF, Langenhorst BL, et al. Health-related quality of life in patients treated for incisional hernia with an onlay technique. Hernia 2010;14:237–42. 13. Mussack T, Ladurner R, Vogel T, et al. Health-related quality-of-life changes after laparoscopic and open incisional hernia repair: a matched pair analysis. Surg Endosc 2006;20:410–3. 14. Itani KM, Hur K, Kim LT, et al. Comparison of laparoscopic and open repair with mesh for the treatment of ventral incisional hernia: a randomized trial. Arch Surg 2010;145:322–8; discussion, 328. 15. Hope WW, Lincourt AE, Newcomb WL, et al. Comparing quality-of-life outcomes in symptomatic patients undergoing laparoscopic or open ventral hernia repair. J Laparoendosc Adv Surg Tech A 2008;18:567–71. 16. Rogmark P, Petersson U, Bringman S, et al. Short-term outcomes for open and laparoscopic midline incisional hernia repair: a randomized multicenter controlled trial: the ProLOVE (prospective randomized trial on open versus laparoscopic operation of ventral eventrations) trial. Ann Surg 2013;258:37–45. 17. Eriksen JR, Poornoroozy P, Jørgensen LN, et al. Pain, quality of life and recovery after laparoscopic ventral hernia repair. Hernia 2009; 13:13–21. 18. Bansal VK, Misra MC, Babu D, et al. Comparison of long-term outcome and quality of life after laparoscopic repair of incisional and ventral hernias with suture fixation with and without tacks: a prospective, randomized, controlled study. Surg Endosc 2012;26:3476–85. 19. Wassenaar E, Schoenmaeckers E, Raymakers J, et al. Mesh-fixation method and pain and quality of life after laparoscopic ventral or incisional hernia repair: a randomized trial of three fixation techniques. Surg Endosc 2010;24:1296–302. 20. Muysoms F, Vander Mijnsbrugge G, Pletinckx P, et al. Randomized clinical trial of mesh fixation with ‘‘double crown’’ versus ‘‘sutures and tackers’’ in laparoscopic ventral hernia repair. Hernia 2013;17:603–12. 21. Snyder CW, Graham LA, Vick CC, et al. Patient satisfaction, chronic pain, and quality of life after elective incisional hernia repair: effects of recurrence and repair technique. Hernia 2011;15:123–9. 22. Jenkinson C, Layte R, Jenkinson D, et al. A shorter form health survey: can the SF-12 replicate results from the SF-36 in longitudinal studies? J Public Health Med 1997;19:179–86. 23. Canziani M, Frattini F, Cavalli M, et al. Sutureless mesh fibrin glue incisional hernia repair. Hernia 2009;13:625–9. 24. Heniford BT, Walters AL, Lincourt AE, et al. Comparison of generic versus specific quality-of-life scales for mesh hernia repairs. J Am Coll Surg 2008;206:638–44. 25. Colavita PD, Tsirline VB, Belyansky I, et al. Prospective, long-term comparison of quality of life in laparoscopic versus open ventral hernia repair. Ann Surg 2012;256:714–22; discussion, 722–3. 26. Wormer BA, Walters AL, Bradley 3rd JF, et al. Does ventral hernia defect length, width, or area predict postoperative quality of life? Answers from a prospective, international study. J Surg Res 2013;184: 169–77. 27. Tsirline VB, Colavita PD, Belyansky I, et al. Preoperative pain is the strongest predictor of postoperative pain and diminished quality of life after ventral hernia repair. Am Surg 2013;79:829–36. 28. Klima DA, Tsirline VB, Belyansky I, et al. Quality of life following component separation versus standard open ventral hernia repair for large hernias. Surg Innov 2014;21:147–54.
K.K. Jensen et al.
Quality of life and incisional hernia
29. Eypasch E, Williams JI, Wood-Dauphinee S, et al. Gastrointestinal Quality of Life Index: development, validation and application of a new instrument. Br J Surg 1995;82:216–22. 30. Paul A, Korenkov M, Peters S, et al. Unacceptable results of the Mayo procedure for repair of abdominal incisional hernias. Eur J Surg 1998; 164:361–7. 31. Korenkov M, Sauerland S, Arndt M, et al. Randomized clinical trial of suture repair, polypropylene mesh or autodermal hernioplasty for incisional hernia. Br J Surg 2002;89:50–6. 32. Marchesi F, Pinna F, Cecchini S, et al. Prospective comparison of laparoscopic incisional ventral hernia repair and Chevrel technique. Surg Laparosc Endosc Percutan Tech 2011;21:306–10. 33. Uranues S, Salehi B, Bergamaschi R. Adverse events, quality of life, and recurrence rates after laparoscopic adhesiolysis and recurrent incisional hernia mesh repair in patients with previous failed repairs. J Am Coll Surg 2008;207:663–9. 34. Krpata DM, Schmotzer BJ, Flocke S, et al. Design and initial implementation of HerQLes: a hernia-related quality-of-life survey to assess abdominal wall function. J Am Coll Surg 2012;215:635–42. 35. Yates JW, Chalmer B, McKegney FP. Evaluation of patients with advanced cancer using the Karnofsky performance status. Cancer 1980;45:2220–4. 36. EuroQol Group. EuroQolda new facility for the measurement of health-related quality of life. Health Policy 1990;16:199–208. 37. Asencio F, Aguilo´ J, Peiro´ S, et al. Open randomized clinical trial of laparoscopic versus open incisional hernia repair. Surg Endosc 2009; 23:1441–8.
493 38. Ra¨sa¨nen JV, Niskanen MM, Miettinen P, et al. Health-related quality of life before and after gastrointestinal surgery. Eur J Surg 2001; 167:419–25. 39. Sintonen H. The 15D instrument of health-related quality of life: properties and applications. Ann Med 2001;33:328–36. 40. Ware Jr JE, Kosinski M, Gandek B, et al. The factor structure of the SF-36 Health Survey in 10 countries: results from the IQOLA Project. International Quality of Life Assessment. J Clin Epidemiol 1998;51: 1159–65. 41. Urbach DR. Measuring quality of life after surgery. Surg Innov 2005; 12:161–5. 42. Zaborszky A, Gyanti R, Barry JA, et al. Measurement issues when assessing quality of life outcomes for different types of hernia mesh repair. Ann R Coll Surg Engl 2011;93:281–5. 43. Chaichana KL, Mukherjee D, Adogwa O, et al. Correlation of preoperative depression and somatic perception scales with postoperative disability and quality of life after lumbar discectomy. J Neurosurg Spine 2011;14:261–7. 44. Browne JP, Bastaki H, Dawson J. What is the optimal time point to assess patient-reported recovery after hip and knee replacement? A systematic review and analysis of routinely reported outcome data from the English patient-reported outcome measures programme. Health Qual Life Outcomes 2013;11:128. 45. Huskisson EC. Measurement of pain. Lancet 1974;2:1127–31. 46. van Ramshorst GH, Eker HH, Hop WC, et al. Impact of incisional hernia on health-related quality of life and body image: a prospective cohort study. Am J Surg 2012;204:144–50.
Review
Standardized measurement of quality of life after incisional hernia repair: a systematic review Kristian K. Jensen, M.D.*, Nadia A. Henriksen, M.D., Ph.D., Henrik Harling, M.D., M.Sc. Digestive Disease Center, Bispebjerg Hospital, University of Copenhagen, Bispebjerg Bakke 23, 2400 Copenhagen NV, Denmark
KEYWORDS: Quality of life; Incisional hernia; Hernia; Pain; Questionnaire; Patient-reported outcome
Abstract BACKGROUND: Recent improvements in incisional hernia repair have led to lower rates of recurrence. As a consequence, increasing attention has been paid to patient-reported outcomes after surgery. However, there is no consensus on how to measure patients’ quality of life after incisional hernia repair. The aim of this systematic review was to analyze existing standardized methods to measure quality of life after incisional hernia repair. DATA SOURCES: A PubMed and Embase search was carried out together with a cross-reference search of eligible papers, giving a total of 26 included studies. CONCLUSIONS: Different standardized methods for measurement of quality of life after incisional hernia repair are available, but no consensus on the optimal method, timing, or length of follow-up exist. International guidelines could help standardization, enabling better comparison between studies. Ó 2014 Elsevier Inc. All rights reserved.
Incisional hernia is a common complication after abdominal surgery, with reported incidences varying from 5% to 20%.1,2 In recent years, the surgery for incisional hernias has undergone a tremendous development with the introduction of new prosthetic material, laparoscopic methods, and component separation.3 This has led to an overall reduction in recurrence rates,4 and thus an increased attention has been directed toward other outcomes such as quality of life. Several factors may influence quality of life after incisional hernia repair such as pain, mobility
The authors declare no conflicts of interest. * Corresponding author. Tel.: 145-531-2201; fax: 145-3531-2891. E-mail address: [email protected] Manuscript received December 16, 2013; revised manuscript April 2, 2014 0002-9610/$ - see front matter Ó 2014 Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.amjsurg.2014.04.004
impairment, cosmetics, and length of convalescence. Besides, patient-reported outcome results are not only important to the patient, but also a factor highly relevant in the ongoing cost-effectiveness debate.5 The purpose of this study was to review the existing literature examining quality of life by standardized methods after incisional hernia repair.
Methods A PubMed and EMBASE search from January 1980 to November 2013 was carried out with the search terms ‘‘incisional hernia AND quality of life’’ combined with the Medical Subject Headings terms ‘‘pain,’’ ‘‘pain measurement,’’ ‘‘questionnaires,’’ and ‘‘hernia, ventral.’’ Filter options selected were publication type ‘‘articles’’ and
486
The American Journal of Surgery, Vol 208, No 3, September 2014
language ‘‘English.’’ Inclusion criteria were studies that used a standardized method to examine quality of life in patients who had undergone incisional hernia repair. Studies reporting quality of life by nonstandardized methods were excluded, and pain assessment tools were not part of the inclusion criteria. Abstracts, case reports, and letters to the editor were not included.
Results A total of 26 studies were included (Fig. 1) reporting quality of life by a standardized method after incisional hernia repair (Table 1). The timing of quality of life assessments varied from the first postoperative day to 5.6 years after surgery. A preoperative quality of life assessment was performed in 16 of the 26 studies (62 %). Eight different quality of life measurement methods were used and in 2 studies 2 different methods were used (Table 2).
Short-Form 36 The most common method for measuring quality of life was the Short-Form 36, which was used in 14 studies. Short-Form 36 was originally derived from the Medical
Figure 1
Outcome Study and is a health survey instrument comprised of 36 items, which assess 8 different health concepts (physical functioning, role physical, bodily pain, general health perceptions, vitality, social functioning, role emotional, and mental health) and summarizes into 2 main outcomes: physical and mental health score.6 It takes 7 to 10 minutes for a patient to self-administer6 and in general, the Short-Form 36 is the most frequently used quality of life assessment tool.7 The Short-Form 36 is neither disease- nor treatment specific, and therefore not restricted to surgical patients. Five studies reported quality of life after open mesh repair. Three studies comparing different types of meshes found no differences in quality of life at 6 and 24 months follow-up, respectively.8–10 Tollens et al11 reported a longterm follow-up of 4 years of 135 patients treated with sublay mesh repair, of whom 18 patients had recurrent incisional hernias. The main finding in this study was that hernia recurrence had a significantly negative effect on quality of life with regard to both physical functioning and general health, as compared with no recurrence. One study examined quality of life in 69 patients treated for an incisional hernia with onlay mesh repair12 and after 64 months of follow-up, the quality of life was comparable with a matched control group of patients without hernia.
Literature search flow chart.
Studies assessing quality of life by standardized methods after incisional hernia repair
Reference
n
Procedure
Preoperative assessment
NS
QOL assessment
Results
Yes
2 and 12 months postoperative
15D
Laparoscopic or open mesh repair
Yes
1, 6, and 12 months postoperative
CCS
Open component separation or standard open mesh repair Laparoscopic or open repair
Yes
,1 month and 6– 12 months postoperative 1, 6, 12, and 24 months postoperative
CCS
Improved QOL after surgery (hernia repair, fundoplication, cholecystectomy, and bowel resection) Laparoscopic repair is associated with decreased QOL in the short term compared with open Similar QOL outcomes with the 2 techniques
Open mesh or laparoscopic repair
Yes
2 weeks, 4 weeks, and 6 months postoperative
CCS
84
Laparoscopic or open mesh repair
No
EuroQol-5D
Marchesi et al32
41
No
1, 2, 3, 7, 15 days, and 1, 3, 12 months postoperative 1 month postoperative
Korenkov et al31
160
No
1 year postoperative
No
20
Colavita et al25
710
Klima et al28
228
Wormer et al26
865
Tsirline et al27
512
Asencio et al37
Ra¨sa¨nen et al
No
Paul et al30
88
Open and laparoscopic repair Suture repair, autodermal skin graft, or onlay mesh repair Open suture repair
Uranues et al33
85
Laparoscopic mesh repair
Yes
2 years postoperative
Krpata et al34
88
Yes
Canziani et al23
40
Open and laparoscopic repair Open mesh fibrin glue repair Sublay lightweight composite or polypropylene mesh repair
2 weeks, 4 weeks, and 6 months postoperative 1 year postoperative
Conze et al8
165
Yes Yes
CCS
Patients with large defect area and transverse defect width have higher odds of pain postoperatively Preoperative pain is a predictor of postoperative pain. Most patients experience resolution of symptoms after 6 months No difference in QOL in regard to technique
Gastrointestinal Quality of Life Index Gastrointestinal Quality of Life Index
No difference in QOL when comparing laparoscopic and open repair No difference in QOL regarding choice of technique
5.7 years postoperative (mean)
Gastrointestinal Quality of Life Index Gastrointestinal Quality of Life Index HerQLes
Patients who underwent suture repair had impaired physical function compared with healthy individuals Improved QOL at follow-up
21 days, 4, 12, and 24 months
SF-12 SF-36
Quality of life and incisional hernia
Follow-up
38
K.K. Jensen et al.
Table 1
Improved QOL after hernia repair Reduced pain and physical component score after surgery No significant difference in outcomes
(continued on next page)
487
488
Table 1
(continued )
Reference
n 9
24
Mussack et al13
48
Tollens et al11
18
Ladurner et al
Itani et al14
Procedure Open sublay repair with light or heavyweight mesh Laparoscopic or open sublay mesh repair Open sublay mesh repair
Preoperative assessment
QOL assessment
Results
No
112 or 75 months postoperative
SF-36
No difference in QOL regarding type of mesh
Yes
16 or 28 months postoperative 49 months postoperative (mean) 2 weeks, 8 weeks, and 12 months postoperative
SF-36
No differences in long-term QOL between open and laparoscopic repair Hernia recurrence has a negative effect on QOL Improved QOL after surgery, no differences between open and laparoscopic repair. VAS: mean worst pain score was lower in laparoscopic group Improved QOL at follow-up. No difference in QOL between the 2 groups Significantly affected QOL up to 6 months after surgery Sutures and tackers group had higher VAS scores after 3 months, similar QOL
No
SF-36 SF-36
146
Open mesh or laparoscopic repair
Yes
Bansal et al18
50
Laparoscopic mesh repair with tackers or sutures
Yes
3 months postoperative
SF-36
Eriksen et al17
35
Laparoscopic mesh repair
Yes
SF-36
Muysoms et al20
76
Yes
Rogmark et al16
133
Wassenaar et al19
199
Laparoscopic repair with double crown or transfacial sutures and one row of tackers Laparoscopic repair or open sublay mesh repair Laparoscopic repair: absorbable sutures with tacks, double crown, or nonabsorbable sutures Open sublay nonabsorbable/ absorbable mesh Various incisional hernia repairs
30 days and 6 months postoperative 3 months postoperative
Rickert et al10
80
Snyder et al21
361
Hope et al15
56
Poelman et al12
69
Laparoscopic or open mesh repair Open onlay mesh repair
Yes
SF-36
Yes
1.5, 3, 4, and 6 weeks postoperative 3 months postoperative
SF-36
Laparoscopic repair leads to better physical function No difference in VAS or QOL in regard to fixation technique
SF-36
No
21 days and 6 months
SF-36
Similar outcomes with 2 different meshes
No
56–62 (median)
SF-36
Yes
At least 6 months
SF-36 and CCS
No
64 months (mean)
SF-36 and Karnofsky Performance Status Scale
Repair technique has no independent effect on patient satisfaction, chronic pain, or QOL Improved QOL with laparoscopic repair compared with open QOL comparable with matched controls. Karnofsky Performance Status Scale score: patients had some signs of disease
CCS 5 Carolinas Comfort Scale; HerQLes 5 Hernia-Related Quality-of-Life Survey; NS 5 not stated; QOL 5 quality of life; SF-12 5 Short-Form 12; SF-36 5 Short-Form 36; VAS 5 Visual Analogue Scale.
The American Journal of Surgery, Vol 208, No 3, September 2014
Follow-up
K.K. Jensen et al.
Standardized questionnaires used to assess quality of life after incisional hernia repair
Name
Times used
Hernia specific
No. of questions
Output
Physical components
Mental components
Short-Form 36
14
No
36
Physical and mental health summary score Score of 0: 100
Physical functioning, role limitations caused by physical health problems, energy/fatigue, and pain
Short-Form 12
1
No
12
Physical and mental health summary score Score of 0: 100
Physical functioning, role limitations caused by physical health problems, energy/fatigue, and pain
Carolinas Comfort Scale
5
Yes
23
Score of 0: 115
Gastrointestinal Quality of Life Index
4
No
36
Score of 0: 144
EuroQol-5D
1
No
5
Karnofsky Performance Status Scale 15D
1
No
1
Pain, movement limitation, and mesh sensation for 8 different daily activities Physical role, large bowel function, upper gastrointestinal tract function, and meteorism Mobility, self-care, usual activities, and pain/discomfort None
Role limitations caused by emotional problems, social functioning, emotional well-being, and general health perceptions Role limitations caused by emotional problems, social functioning, emotional well-being, and general health perceptions None
1
No
15
Score of 0: 1 (being deaddno problems on any dimension)
Hernia-Related Quality-ofLife Survey
1
Yes
12
Score of 0: 100
Score of 0: 1 (being deaddperfect health) Decimal score of 0: 100
Breathing, speech, vision, mobility, usual activities, hearing, eating, elimination, discomfort, and symptoms Specific questions on core functioning and its effect on quality of life and abdominal wall function, concerning both physical and mental components
Quality of life and incisional hernia
Table 2
Emotional role
Anxiety/depression, and a visual analog health perception scale Measure of self-perceived health status Mental function, sleeping, distress, sexual activity, vitality, and depression None
489
490
The American Journal of Surgery, Vol 208, No 3, September 2014
Short-Form 36 has been used to assess quality of life after laparoscopic incisional hernia repair in 9 studies. No difference in quality of life after laparoscopic or open sublay repair was found in 2 studies, but quality of life after hernia repair was lower than that of healthy controls.13,14 In contrast, Hope et al15 found that laparoscopic ventral or incisional hernia repair resulted in a significant improvement in quality of life compared with open sublay mesh repair. In this study, both Short-Form 36 and the Carolinas Comfort Scale (described below) were used to assess quality of life, both supporting the superiority of the laparoscopic technique. Somewhat similar findings were reported in a study comparing laparoscopic and open sublay mesh repair in 133 patients.16 Short-term physical functioning was significantly improved in patients treated with laparoscopic approach compared with open repair, although no difference was found in general health. One study assessed quality of life in laparoscopic repair employing double-crown titanium tacks, and reported decreased quality of life in 3 domains (role physical, bodily pain and physical component scale) 1 month postoperative. However, the findings were normalized after 6 months when overall quality of life was comparable with healthy individuals.17 Three studies compared quality of life measured by Short-Form 36 after laparoscopic incisional hernia repair with different mesh fixation techniques and found no difference in overall quality of life,18–20 although a decrease in physical functioning and role limitations because of emotional problems was found after application of tackers with the double-crown technique.19 Finally, Snyder et al21 reported that the use of mesh or suture for incisional hernia repair has no influence on quality of life measured by Short-Form 36 after 5 years.
The Short-Form 12 The Short-Form 12 is a shorter version of the aforementioned Short-Form 36 that provides only a physical and mental component. It has been shown to give results comparable with Short-Form 36, with far less respondent burden.22 One study has used Short-Form 12 to assess changes in quality of life after sutureless mesh fibrin glue incisional hernia repair. It was observed that this technique led to an improved quality of life in the physical component score, while the mental component score was unaffected.23
Carolinas Comfort Scale Five studies analyzed quality of life after incisional hernia repair with the Carolinas Comfort Scale method, which is a 23-item questionnaire measuring severity of pain, sensation, and mobility impairment from an implanted mesh in 8 different categories.24 It is a herniaspecific questionnaire aiming on patients treated with a mesh. In addition to the aforementioned study,15 3 other studies assessed quality of life by the use of Carolinas Comfort Scale. Two studies originating from the
International Hernia Mesh Registry analyzed quality of life after ventral hernia repair by open and laparoscopic approach, using various techniques.25,26 Both incisional and primary ventral hernias were included in both studies. One reported that laparoscopic repair was associated with a decrease in quality of life (discomfort, activity limitation, and overall) after 1 month compared with open repair, but no long-term difference was found.25 Another study concluded that large defect width and total defect area were factors associated with decreased short-term quality of life in both laparoscopic and open incisional hernia repair.26 No difference was found at long-term follow-up. Tsirline et al27 used the Carolinas Comfort Scale to analyze predictors for postoperative pain after open mesh and laparoscopic repair. It was reported that preoperative pain was the strongest predictor for postoperative pain, but in most cases pain had ceased at 6 months of follow-up. One study compared quality of life after open component separation incisional hernia repair and open mesh repair.28 Patients treated with the 2 different techniques had comparable hernia dimensions and comparable quality of life was reported.
The Gastrointestinal Quality of Life Index A third method of measuring quality of life after incisional hernia repair is the Gastrointestinal Quality of Life Index, which is a disease-specific questionnaire designed for patients with gastrointestinal disorders.29 The questionnaire is comprised of 36 items each with 5 response categories. Together they yield a total quality of life score ranging from 0 to 144. One study used Gastrointestinal Quality of Life Index to examine long-term quality of life after open suture repair and found an overall decreased quality of life in patients treated for incisional hernia compared with healthy people30 and hernia recurrence did not influence the quality of life. Similar results were found when comparing Gastrointestinal Quality of Life Index-measured quality of life after either suture repair; mesh repair or autodermal skin graft repair in 160 patients with incisional hernias.31 After at least 9 months of follow-up, no differences in quality of life were found. Marchesi et al32 used the Gastrointestinal Quality of Life Index to compare laparoscopic and open mesh repair in 41 patients, also reporting no difference in quality of life. Finally, one study used the Gastrointestinal Quality of Life Index to assess changes in quality of life after laparoscopic incisional hernia repair.33 An improvement in the total quality of life and the domain’s emotional function, physical function, and symptoms were reported when comparing scores before and 2 years after surgery.
Hernia-Related Quality-of-Life Survey The Hernia-Related Quality-of-Life Survey is a herniaspecific quality of life assessment tool, consisting of 12 items that patients score from 1 to 6.34 One study has used Hernia-Related Quality-of-Life Survey to assess quality of
K.K. Jensen et al.
Quality of life and incisional hernia
life in patients undergoing open mesh or laparoscopic repair for primary and incisional hernia, reporting improved quality of life after 4 weeks but no further improvement after 6 months.34
Karnofsky Performance Status Scale Karnofsky Performance Status Scale is a measure of functional performance on a scale from 0 to 100. A score of 100 indicates that the patient can fully function and perform all activities of daily life with no evidence of disease, while a score of 0 is death. The scale was originally developed for evaluation in cancer patients, but has proved a valid tool in the assessment of patients with a chronic disease.35 The Karnofsky Performance Status Scale has been used in one previously mentioned study.12 In this study of onlay mesh repair, the Karnofsky Performance Status Scale score indicated that activities could be performed with effort and that patients had some signs of disease, indicating that the Karnofsky Performance Status Scale did detect some degree of decreased quality of life that was not detected by Short-Form 36.
EuroQol The EuroQol is a health-related quality of life scale, which consists of 5 questions concerning usual activity, self-care, mobility, pain or discomfort, and anxiety or depression. After the patient has answered these questions, a value between 0 and 1 is calculated, 0 being ‘‘death’’ and 1 ‘‘perfect health.’’36 The EuroQol has been used to compare laparoscopic and/or open inlay or onlay mesh repair of incisional hernia, and no differences in quality of life after 1 year of follow-up were reported.37 However, quality of life was decreased initially after surgery but improved until 1 year postoperatively.
15D Finally, one study analyses quality of life after various surgical procedures, including open incisional hernia repair with and without mesh (n 5 20), using the 15D questionnaire.38 The 15D is a generic, 15-dimensional, standardized questionnaire, which describe 15 different dimensions: breathing, mental function, speech, vision, mobility, usual activities, vitality, hearing, eating, elimination, sleeping, distress, discomfort and symptoms, sexual activity, and depression. Each dimension is stratified into 5 levels and transforms into a total score ranging from 0 to 1.39 In this study, no difference in quality of life was found when comparing preoperative status with follow-up results at 2 and 12 months.
Comments Eight different standardized methods of measuring healthrelated quality of life after incisional hernia repair were identified in the current review. Two methods were hernia specific, while one was specific for gastrointestinal disorders.
491 The most common questionnaire was the Short-Form 36, which is thoroughly validated and widely used.40 For these reasons the Short-Form 36 scores are easy to compare with other studies, which is desirable for a number of reasons. The main disadvantage of Short-Form 36 for evaluation of any surgical procedure is that it is generic and not disease specific and therefore prone to be affected by factors not associated with surgery.41 This also applies to the other generic questionnaires described in this review: Short-Form 12, EuroQol, Karnofsky Performance Status Scale, and 15D. Especially the Karnofsky Performance Status Scale, which was originally developed for evaluating cancer patients before initiation of chemotherapy, seems misplaced in the evaluation of a surgical procedure. While the disease-specific Gastrointestinal Quality of Life Index may be more relevant when assessing quality of life after incisional hernia repair, it too has its limitations, as subscales such as digestion and defecation are not affected by an incisional hernia. A more specific evaluation of quality of life in patients treated for an incisional hernia is possible with Hernia-Related Quality-of-Life Survey or Carolinas Comfort Scale, which to our knowledge are the only of their kind. Reliability and validity studies of the Carolinas Comfort Scale compared with Short-Form 36 has been done by the authors behind the Carolinas Comfort Scale, claiming that it is superior to Short-Form 36 when studying quality of life in patients undergoing surgical hernia repair.24 Carolinas Comfort Scale may be best suited for relatively symptomatic patients,42 but it is still a highly specific and relevant questionnaire when examining changes in quality of life related to a single procedure. The importance of a diseasespecific quality of life questionnaire is underlined by the fact that other conditions such as depression play a significant role when using generic questionnaires.43 Equal to Carolinas Comfort Scale, Hernia-Related Quality-of-Life Survey has proved its validity in a single study,34 but the value of this questionnaire awaits more studies. An important question when examining quality of life after surgical procedures is when to do the follow-up. To examine the impact of surgery, an assessment must be done pre- and postoperatively. Only half of the studies included a preoperative quality of life assessment. Furthermore, it remains unclear as to how long after incisional hernia repair the optimal assessment should be undertaken. In this review, several studies reported a decreased quality of life immediately after surgery, which returned to the preoperative level or higher subsequently. In orthopedic surgery, a recent review concluded that a follow-up of 12 months is desirable when assessing quality of life after hip and knee replacement,44 but of course this recommendation may be of little relevance for hernia surgery. Because no consensus on the method of measuring quality of life after incisional hernia repair exists, results are seldom comparable. Furthermore, the length of follow-up is infrequently comparable, which complicates comparisons even more. Another important issue when evaluating quality of life after incisional hernia repair is, which control group to use.
492
The American Journal of Surgery, Vol 208, No 3, September 2014
Several studies compared postoperative quality of life after incisional hernia repair with a group of healthy controls not having hernias and not undergoing surgery.12–14 One may argue that this comparison is irrelevant. To the best of our knowledge, there are no randomized controlled trials comparing quality of life in symptomatic incisional hernia patients randomized to surgery or watchful waiting strategy, meaning that the true impact of incisional hernia surgery on quality of life is in fact unknown. Other ways of measuring subjective outcomes of incisional hernia repair are found in the literature. In 9 of the included studies in this review, the quality of life questionnaire was combined with the Visual Analogue Scale for assessment of pain. The Visual Analogue Scale is a visual scale of 100 mm, ranging from 0 (no pain) to 100 (pain as bad as it could be), which has been used for more than a quarter of a century.45 Although the Visual Analogue Scale quantifies the pain a patient experiences, this is only one of the factors of overall quality of life after surgery. Another contributing factor to the overall quality of life is the patients’ self-perception, examined by the Body Image Questionnaire. The Body Image Questionnaire has been used to assess how patients with incisional hernias perceive their body image, finding that body image scores are significantly lower in patients with incisional hernias compared with healthy persons.46 In conclusion, there are several standardized methods for examining quality of life after incisional hernia repair, both generic and disease specific. Presently, however, no consensus on either the optimal method or timing of the measurement exists, calling for international guidelines on this topic, to enable comparison across the different studies. The authors of this review consider a combination of the existing methods ideal, providing a questionnaire assessing both disease-specific and generic aspects of quality of life. Thus a combination of Short-Form 36 and Hernia-Related Quality-of-Life Survey or Carolinas Comfort Scale presently should be the optimal method for quality of life assessment.
References 1. Millbourn D, Cengiz Y, Israelsson LA. Effect of stitch length on wound complications after closure of midline incisions: a randomized controlled trial. Arch Surg 2009;144:1056–9. 2. Mudge M, Hughes LE. Incisional hernia: a 10 year prospective study of incidence and attitudes. Br J Surg 1985;72:70–1. 3. Ramirez OM, Ruas E, Dellon AL. ‘‘Components separation’’ method for closure of abdominal-wall defects: an anatomic and clinical study. Plast Reconstr Surg 1990;86:519–26. 4. Luijendijk RW, Hop WC, van den Tol MP, et al. A comparison of suture repair with mesh repair for incisional hernia. N Engl J Med 2000; 343:392–8. 5. Coronini-Cronberg S, Appleby J, Thompson J. Application of patientreported outcome measures (PROMs) data to estimate cost-effectiveness of hernia surgery in England. J R Soc Med 2013;106:278–87. 6. Hays RD, Morales LS. The RAND-36 measure of health-related quality of life. Ann Med 2001;33:350–7. 7. Coons SJ, Rao S, Keininger DL, et al. A comparative review of generic quality-of-life instruments. Pharmacoeconomics 2000;17:13–35.
8. Conze J, Kingsnorth AN, Flament JB, et al. Randomized clinical trial comparing lightweight composite mesh with polyester or polypropylene mesh for incisional hernia repair. Br J Surg 2005;92:1488–93. 9. Ladurner R, Chiapponi C, Linhuber Q, et al. Long term outcome and quality of life after open incisional hernia repairdlight versus heavy weight meshes. BMC Surg 2011;11:25. 10. Rickert A, Kienle P, Kuthe A, et al. A randomised, multi-centre, prospective, observer and patient blind study to evaluate a non-absorbable polypropylene mesh vs. a partly absorbable mesh in incisional hernia repair. Langenbecks Arch Surg 2012;397:1225–34. 11. Tollens T, Den Hondt M, Devroe K, et al. Retrospective analysis of umbilical, epigastric, and small incisional hernia repair using the VentralexÔ hernia patch. Hernia 2011;15:531–40. 12. Poelman MM, Schellekens JF, Langenhorst BL, et al. Health-related quality of life in patients treated for incisional hernia with an onlay technique. Hernia 2010;14:237–42. 13. Mussack T, Ladurner R, Vogel T, et al. Health-related quality-of-life changes after laparoscopic and open incisional hernia repair: a matched pair analysis. Surg Endosc 2006;20:410–3. 14. Itani KM, Hur K, Kim LT, et al. Comparison of laparoscopic and open repair with mesh for the treatment of ventral incisional hernia: a randomized trial. Arch Surg 2010;145:322–8; discussion, 328. 15. Hope WW, Lincourt AE, Newcomb WL, et al. Comparing quality-of-life outcomes in symptomatic patients undergoing laparoscopic or open ventral hernia repair. J Laparoendosc Adv Surg Tech A 2008;18:567–71. 16. Rogmark P, Petersson U, Bringman S, et al. Short-term outcomes for open and laparoscopic midline incisional hernia repair: a randomized multicenter controlled trial: the ProLOVE (prospective randomized trial on open versus laparoscopic operation of ventral eventrations) trial. Ann Surg 2013;258:37–45. 17. Eriksen JR, Poornoroozy P, Jørgensen LN, et al. Pain, quality of life and recovery after laparoscopic ventral hernia repair. Hernia 2009; 13:13–21. 18. Bansal VK, Misra MC, Babu D, et al. Comparison of long-term outcome and quality of life after laparoscopic repair of incisional and ventral hernias with suture fixation with and without tacks: a prospective, randomized, controlled study. Surg Endosc 2012;26:3476–85. 19. Wassenaar E, Schoenmaeckers E, Raymakers J, et al. Mesh-fixation method and pain and quality of life after laparoscopic ventral or incisional hernia repair: a randomized trial of three fixation techniques. Surg Endosc 2010;24:1296–302. 20. Muysoms F, Vander Mijnsbrugge G, Pletinckx P, et al. Randomized clinical trial of mesh fixation with ‘‘double crown’’ versus ‘‘sutures and tackers’’ in laparoscopic ventral hernia repair. Hernia 2013;17:603–12. 21. Snyder CW, Graham LA, Vick CC, et al. Patient satisfaction, chronic pain, and quality of life after elective incisional hernia repair: effects of recurrence and repair technique. Hernia 2011;15:123–9. 22. Jenkinson C, Layte R, Jenkinson D, et al. A shorter form health survey: can the SF-12 replicate results from the SF-36 in longitudinal studies? J Public Health Med 1997;19:179–86. 23. Canziani M, Frattini F, Cavalli M, et al. Sutureless mesh fibrin glue incisional hernia repair. Hernia 2009;13:625–9. 24. Heniford BT, Walters AL, Lincourt AE, et al. Comparison of generic versus specific quality-of-life scales for mesh hernia repairs. J Am Coll Surg 2008;206:638–44. 25. Colavita PD, Tsirline VB, Belyansky I, et al. Prospective, long-term comparison of quality of life in laparoscopic versus open ventral hernia repair. Ann Surg 2012;256:714–22; discussion, 722–3. 26. Wormer BA, Walters AL, Bradley 3rd JF, et al. Does ventral hernia defect length, width, or area predict postoperative quality of life? Answers from a prospective, international study. J Surg Res 2013;184: 169–77. 27. Tsirline VB, Colavita PD, Belyansky I, et al. Preoperative pain is the strongest predictor of postoperative pain and diminished quality of life after ventral hernia repair. Am Surg 2013;79:829–36. 28. Klima DA, Tsirline VB, Belyansky I, et al. Quality of life following component separation versus standard open ventral hernia repair for large hernias. Surg Innov 2014;21:147–54.
K.K. Jensen et al.
Quality of life and incisional hernia
29. Eypasch E, Williams JI, Wood-Dauphinee S, et al. Gastrointestinal Quality of Life Index: development, validation and application of a new instrument. Br J Surg 1995;82:216–22. 30. Paul A, Korenkov M, Peters S, et al. Unacceptable results of the Mayo procedure for repair of abdominal incisional hernias. Eur J Surg 1998; 164:361–7. 31. Korenkov M, Sauerland S, Arndt M, et al. Randomized clinical trial of suture repair, polypropylene mesh or autodermal hernioplasty for incisional hernia. Br J Surg 2002;89:50–6. 32. Marchesi F, Pinna F, Cecchini S, et al. Prospective comparison of laparoscopic incisional ventral hernia repair and Chevrel technique. Surg Laparosc Endosc Percutan Tech 2011;21:306–10. 33. Uranues S, Salehi B, Bergamaschi R. Adverse events, quality of life, and recurrence rates after laparoscopic adhesiolysis and recurrent incisional hernia mesh repair in patients with previous failed repairs. J Am Coll Surg 2008;207:663–9. 34. Krpata DM, Schmotzer BJ, Flocke S, et al. Design and initial implementation of HerQLes: a hernia-related quality-of-life survey to assess abdominal wall function. J Am Coll Surg 2012;215:635–42. 35. Yates JW, Chalmer B, McKegney FP. Evaluation of patients with advanced cancer using the Karnofsky performance status. Cancer 1980;45:2220–4. 36. EuroQol Group. EuroQolda new facility for the measurement of health-related quality of life. Health Policy 1990;16:199–208. 37. Asencio F, Aguilo´ J, Peiro´ S, et al. Open randomized clinical trial of laparoscopic versus open incisional hernia repair. Surg Endosc 2009; 23:1441–8.
493 38. Ra¨sa¨nen JV, Niskanen MM, Miettinen P, et al. Health-related quality of life before and after gastrointestinal surgery. Eur J Surg 2001; 167:419–25. 39. Sintonen H. The 15D instrument of health-related quality of life: properties and applications. Ann Med 2001;33:328–36. 40. Ware Jr JE, Kosinski M, Gandek B, et al. The factor structure of the SF-36 Health Survey in 10 countries: results from the IQOLA Project. International Quality of Life Assessment. J Clin Epidemiol 1998;51: 1159–65. 41. Urbach DR. Measuring quality of life after surgery. Surg Innov 2005; 12:161–5. 42. Zaborszky A, Gyanti R, Barry JA, et al. Measurement issues when assessing quality of life outcomes for different types of hernia mesh repair. Ann R Coll Surg Engl 2011;93:281–5. 43. Chaichana KL, Mukherjee D, Adogwa O, et al. Correlation of preoperative depression and somatic perception scales with postoperative disability and quality of life after lumbar discectomy. J Neurosurg Spine 2011;14:261–7. 44. Browne JP, Bastaki H, Dawson J. What is the optimal time point to assess patient-reported recovery after hip and knee replacement? A systematic review and analysis of routinely reported outcome data from the English patient-reported outcome measures programme. Health Qual Life Outcomes 2013;11:128. 45. Huskisson EC. Measurement of pain. Lancet 1974;2:1127–31. 46. van Ramshorst GH, Eker HH, Hop WC, et al. Impact of incisional hernia on health-related quality of life and body image: a prospective cohort study. Am J Surg 2012;204:144–50.
