Tech Coloproctol DOI 10.1007/s10151-014-1156-6
ORIGINAL ARTICLE
Vertical rectus abdominis myocutaneous flap and quality of life following abdominoperineal excision for rectal cancer: a multi-institutional study V. O’Dowd • J. P. Burke • E. Condon • D. Waldron • N. Ajmal • J. Deasy • D. A. McNamara • J. C. Coffey
Received: 7 May 2013 / Accepted: 12 April 2014 Ó Springer-Verlag Italia 2014
Abstract Background To obtain a clear surgical margin, abdominoperineal excision (APE) for rectal cancer frequently leaves a large perineal defect surrounded by irradiated tissue. A vertical rectus abdominis myocutaneous (VRAM) flap may facilitate healing of this wound. The current study aims to determine the effect of VRAM flap perineal reconstruction following APE on patient quality of life (QOL). Methods This is a retrospective cohort study from a prospectively collected database. Data on QOL were assessed via telephone questionnaire using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-C30, EORTC QLQ-C29 and the Cleveland Clinic QOL questionnaires. Results Twenty-seven patients underwent primary perineal closure, and 12 patients underwent a VRAM flap perineal reconstruction. The mean duration of follow-up was 16.8 months. Overall, there was no significant
difference in the Cleveland Clinic QOL score between groups (VRAM vs. no VRAM: 0.7 ± 0.2 vs. 0.7 ± 0.2, p 0.735). Patients in the VRAM group had lower levels of fatigue (5.5 ± 9.9 vs. 23.6 ± 19.2, p 0.004). Patients in the VRAM group had reduced sore skin scores around the stoma site (11.0 ± 16.2 vs. 31.8 ± 31.1, p 0.036). VRAM flap was associated with an increased incidence of abdominal wall hernia (VRAM vs. no VRAM: 25 % vs. 0 %, p 0.024). Conclusions This study is limited by its non-randomized retrospective design and relatively small sample size. A significant difference in patient QOL was not demonstrated between VRAM flap and primary perineal closure after APE for rectal cancer. Further studies in this area are warranted. Keywords Rectal cancer Abdominoperineal excision VRAM flap Quality of life
Introduction Presented in part as a poster presentation at the ASCRS Annual Meeting, San Antonio, Texas, 2–6 June 2012. V. O’Dowd E. Condon D. Waldron J. C. Coffey Departments of Colorectal Surgery, Limerick University Hospital, Limerick, Ireland e-mail: [email protected] J. P. Burke (&) J. Deasy D. A. McNamara Department of Colorectal Surgery, Beaumont Hospital, Dublin, Ireland e-mail: [email protected] N. Ajmal Department of Plastic and Reconstructive Surgery, Beaumont Hospital, Dublin, Ireland
With combined modality treatment, survival has improved for rectal cancer [1], and thus, the focus on patient quality of life (QOL) is increasingly relevant. For approximately 24 % of patients with rectal cancer, an abdominoperineal excision (APE) will be necessary for resection of the primary lesion [2]. To obtain a clear surgical margin, APE for rectal cancer frequently leaves a large perineal defect surrounded by irradiated tissue. An alternative to primary perineal wound closure after APE is myocutaneous flap reconstruction, which may be composed of gluteal [3], gracilis, latissimus dorsi [4] or rectus abdominis muscle. The vertical rectus abdominis myocutaneous (VRAM) flap contains skin,
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subcutaneous fat, a cuff of anterior rectus sheath fascia and rectus abdominis muscle. This flap brings vascularized tissue to the irradiated tumour bed, provides tissue bulk to obliterate dead space and simultaneously enables cutaneous wound closure [5]. This theoretically reduces the incidence of perineal sepsis and major perineal wound dehiscence without an increase in abdominal wall complications. The advantages of VRAM flap closure in advanced pelvic malignancy are well established [6] including recreation of a neo-pelvic diaphragm and decreasing perineal herniation [7], and some would argue that this is now the gold standard in pelvic exenterative surgery [8]. VRAM flap reconstruction has been used to close the perineal defect following APE for rectal [9, 10] and anal cancer [11] but also other abdominopelvic malignancies [12] including gynaecologic neoplastic disease [13]. Following en-bloc vaginal excision, the VRAM flap is the most common method for vaginal reconstruction [14, 15]. The effect of VRAM flap reconstruction on patient QOL after APE for rectal cancer is unknown. The current study compares QOL and surgery-related morbidity in patients who have undergone VRAM flap reconstruction or primary perineal wound closure after APE.
Materials and methods Centres This multi-institutional study was a retrospective cohort study from prospectively collected databases identifying patients in Limerick University Hospital and Beaumont Hospital who underwent APE between 1 January 2008 and 30 June 2011. Patients were eligible for inclusion if they had undergone APE for rectal cancer in Limerick University Hospital or if they had APE with VRAM flap reconstruction in Beaumont Hospital (where the routine practice is to reconstruct the perineal defect after APE with a VRAM flap). Patients were excluded if they had APE for anal cancer, were no longer alive or declined to participate. Following the approval of the institutional ethics committee, patients were identified from prospectively collated databases and additional details were obtained from operative log books, chart review and computerized records. Data recorded included patient age, sex, duration of followup, TNM stage, neoadjuvant/adjuvant treatment, length of stay and surgery-related morbidity. Based on the results of the preoperative assessment and multidisciplinary team discussion, patients underwent neoadjuvant therapy in locally advanced cases. The preoperative workup included a physical examination, colonoscopy, rigid sigmoidoscopy, magnetic resonance imaging
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of the pelvis (or endorectal ultrasound) and computed tomography of the chest, abdomen and pelvis. The majority of patients with suspected nodal involvement and/or invasion of the mesorectum underwent neoadjuvant longcourse radiotherapy (50.4 Gy over 6 weeks) with or without 5-fluorouracil-based chemotherapy. Surgery after the completion of neoadjuvant therapy was scheduled after 6 weeks. Management was concordant in both units. Five fellowship trained, colorectal surgeons performed APE using a uniform technical approach in both centres. Training was similar among all involved surgeons. The indication for APE in both institutions was that an adequate radial margin and 2-cm distal margin could not be achieved while maintaining anal sphincter complex integrity. The mesorectal plane was dissected to the level of the prostate (or below the cervix). The perineal approach was used for wide excision of the anus and distal rectum. Extralevator APE was not performed, and no supplemental omentoplasty or mesh was used to close the perineal defect. Flap reconstruction of the perineal defect was performed in the VRAM group by the same plastic surgeon (NA). This involved a skin paddle, which was designed vertically above the right rectus abdominis muscle. The inferior epigastric pedicle was mobilized to its origin, after which the flap along with its blood supply was rotated medially and transposed onto the perineal defect. With the patient in the lithotomy position, the skin paddle was marked, deepithelialized and sutured to the remnant pelvic floor. Flap skin was then sutured to perineal skin defect edges. The abdominal donor site was closed, after contralateral colostomy placement, with the aid of a prosthetic prolene mesh to support the posterior sheath. VRAM flap-assisted vaginal reconstruction was not performed in any patient. QOL tools Patients were contacted by telephone, verbal consent for participation was obtained, they were then interviewed by a single interviewer (V O’D), and QOL scores were determined. QOL was assessed using the cancer-specific questionnaire from the European Organisation for Research and Treatment of Cancer (EORTC QLQ-C30) [16] and the recently validated colorectal-specific EORTC QLQ-CR29 [17]. The Cleveland Clinic (CC) QOL score was used in addition for comparative purposes [18]. The EORTC QLQC30 consists of 30 questions that are believed to be relevant to all cancer patients; it examines aspects of QOL such as global health, physical, social and emotional functioning as well as symptoms of fatigue, pain scores and appetite disturbances. The EORTC QLQ-CR29 focuses on patients with colorectal cancer, examining aspects such as body image following stoma formation, bowel and urinary symptoms, stoma care problems and sexual function, and
Tech Coloproctol Table 1 Patient and tumour demographics
Table 2 Comparison of EORTC QLQ-C30 scores in the two groups
No VRAM (n = 27)
VRAM (n = 12)
p value
Age at surgery (years)
61.5 ± 11.0
66.7 ± 12.9
0.215
Male sex
22
7
0.232
Physical function
84.5 ± 18.5
91.5 ± 13.0
0.245
Time since surgery (months)
18.2 ± 13.8
15.2 ± 6.8
0.479
Role function
80.7 ± 25.3
81.8 ± 26.0
0.902
Emotional function
77.8 ± 20.6
85.4 ± 81.3
0.280
T1
1
0
1.000
Cognitive function
81.3 ± 22.9
77.7 ± 33.6
0.693
T2
2
1
1.000
Social function
76.9 ± 22.8
84.5 ± 22.1
0.338
T3 T4
14 10
8 3
0.494 0.714
Fatigue Nausea/vomiting
23.6 – 19.2 6.1 ± 12.2
5.5 – 9.9 2.8 ± 9.5
0.004 0.401
Pain
9.9 ± 13.2
2.8 ± 6.6
0.089
T0
3
3
0.348
Dyspnoea
6.1 ± 22.6
16.5 ± 22.2
0.194
T1
0
3
0.024
Insomnia
17.1 ± 23.1
22.0 ± 32.5
0.595
T2
3
1
1.000
Appetite loss
6.1 ± 16.0
T3
16
5
0.488
Constipation
14.7 ± 24.8
T4
5
0
0.299
Diarrhoea
12.3 ± 22.8
16.5 ± 22.2
0.593
8.6 ± 19.6
16.5 ± 26.3
0.301
Radiological T stage
Pathological T stage
Radiological N stage
Global health
Financial difficulties
No VRAM (n = 27)
VRAM (n = 12)
p value
70.4 ± 22.2
74.3 ± 18.5
0.596
0.0 ± 0.0 8.3 ± 20.5
N0
13
3
0.291
Bold values are statistically significant
N1
7
5
0.262
VRAM ventral rectus abdominus myocutaneous flap
N2
7
4
0.709
N0
12
4
0.269
N1
8
4
1.000
N2 Metastasis at presentation
7 2
4 0
0.077 1.000
1
0
2
0.089
2
12
2
0.151
3
13
8
0.322 1.000
0.196 0.438
Pathological N stage
Final stage of disease
4
2
0
Positive resection margin
0
0
–
Preoperative radiotherapy
20
12
0.077
Preoperative chemotherapy
11
10
0.034
Postoperative chemotherapy
17
7
0.728
Postoperative stay (days)
19.5 ± 13.1
19.0 ± 13.2
0.919
Perineal wound separation
9
3
0.719
Vacuum dressing for perineal wound closure
6
0
0.151
Abdominal wall hernia
0
3
0.024
Perineal hernia
0
0
–
VRAM ventral rectus abdominus myocutaneous flap
has recently been updated from the EORTC QLQ-C38 [17]. Both EORTC questionnaires focus on the patient’s experiences during the previous week. There were 4 response categories: 1 (not at all) to 4 (very much), a higher score was a positive for functional score (better function) and a negative for symptoms (more symptoms). In the CC global QOL score (or Fazio score), patients are asked to rate 3 items (perception of their own health, current quality
of health and current energy level), each on a scale of 0–10 (0, worst; 10, best). The scores were added, and the final CC global QOL utility score was obtained by dividing this result by 30 [18]. Statistic analysis All data are expressed as mean ± standard deviation (SD), and n represents the number of patients. Statistical significance between groups was determined using Fisher’s exact test for categorical variables, and analysis of variance (ANOVA) for continuous variables. p \ 0.05 was considered significant. Data were analysed using SPSS version 12.0 (SPSS, Chicago, Illinois, USA).
Results Participant and tumour demographics Over the study period, 278 patients underwent proctectomy for rectal adenocarcinoma (137 in Limerick University Hospital and 141 in Beaumont Hospital). Thirty-nine patients underwent APE and were eligible for inclusion (12 underwent VRAM flap reconstruction and 27 underwent primary perineal closure) (Table 1). All patients invited to participate did so. There was no significant difference in patient age at surgery, gender or duration of follow-up. Patients in the VRAM group more frequently had T1 tumours on final
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Tech Coloproctol Table 3 EORTC QLQ-CR29 scores between groups No VRAM (n = 27)
VRAM (n = 12)
Table 4 Cleveland Clinic quality of life scores in the two groups p value
No VRAM (n = 27)
VRAM (n = 12)
p value
Quality of life
7.2 ± 2.1
7.3 ± 1.8
0.928
Body image
73.9 ± 30.5
87.0 ± 28.1
0.213
Health
7.4 ± 2.1
7.8 ± 1.8
0.663
Anxiety
28.1 ± 29.9
16.5 ± 26.3
0.255
Energy levels
6.7 ± 2.0
7.0 ± 1.8
0.622
Weight
14.7 ± 28.1
24.9 ± 37.9
0.354
Overall score
0.7 ± 0.2
0.7 ± 0.2
0.735
Sexual interest
32.0 ± 44.8
36.4 ± 50.5
0.796
Urinary frequency
38.0 ± 23.3
45.7 ± 14.3
0.302
Blood/mucus in stool
2.4 ± 13.0
0.0 ± 0.0
0.512
Stool frequency Urinary incontinence
12.9 ± 14.7 9.8 ± 20.1
15.2 ± 21.6 19.3 ± 22.1
0.693 0.195
7.4 ± 21.3
0.0 ± 0.0
0.242
Dysuria Abdominal pain
12.2 ± 22.7
2.8 ± 9.5
0.175
Buttock pain
22.0 ± 29.0
8.3 ± 14.9
0.130
Bloating
15.9 ± 23.1
13.8 ± 17.0
0.776
Dry mouth
19.6 ± 26.3
13.8 ± 30.0
0.552
Hair loss
4.9 ± 15.0
13.8 ± 22.1
0.151
Taste
6.1 ± 20.7
16.5 ± 26.3
0.194
Flatulence
45.3 ± 27.8
63.4 ± 22.4
0.054
Faecal incontinence
30.6 ± 24.1
24.8 ± 20.5
0.473
Sore skin
31.8 – 31.1
11.0 – 16.2
0.036
Embarrassment
26.9 ± 31.8
19.4 ± 38.8
0.529
Stoma care problems Impotence/dyspareunia
4.9 ± 11.9
2.8 ± 9.5
0.588
82.2 ± 31.5
100.0 ± 0.0
0.283
VRAM ventral rectus abdominus myocutaneous flap
EORTC QLQ-CR29 Mean scores EORTC QLQ-CR29 are presented in Table 3. The patients who underwent VRAM flap reconstruction had less symptoms of sore skin around the stoma site than those who underwent primary perineal closure (11.0 ± 16.2 vs. 31.8 ± 31.1, p 0.036). None of the other symptom parameters assessed as part of the EORTC QLQCR29 showed a significant difference between groups. Cleveland Clinic QOL scores Patients were asked to rate their perception of their health, QOL and energy levels; there was no significant difference in overall Cleveland Clinic QOL score between groups as demonstrated in Table 4.
Bold values are statistically significant EORTC QLQ European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, VRAM ventral rectus abdominus myocutaneous flap
histology (3/12 vs. 0/27, p 0.024), but there was no significant difference in lymph node status or presence of metastasis at presentation. There was no significant difference in preoperative radiotherapy or postoperative chemotherapy administration; however, the VRAM group received preoperative chemotherapy more frequently (10/12 vs. 11/27, p 0.034). Postoperative length of stay was equivalent. EORTC QLQ-C30 Mean EORTC QLQ-C30 scores are presented in Table 2. There was no significant difference in global QOL score between groups with patients having similar physical, emotional, cognitive and social functioning. Patients who underwent VRAM flap reconstruction showed lower symptoms of fatigue compared to those who had primary perineal closure (5.5 ± 9.9 vs. 23.6 ± 19.2, p 0.004). All other symptom parameters assessed as part of the EORTC QLQ-C30 showed no significant difference.
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Discussion After the safe and complete removal of rectal cancer, the most important aspect of patient care is the maintenance of QOL. With the increasing incidence of rectal cancer, earlier identification and more successful treatments, patient QOL becomes increasingly relevant. The primary experience with VRAM flap perineal reconstruction in colorectal surgery is following APE for anal cancer. In this setting, the VRAM flap does not adversely affect disease-free survival, but significantly improves the perineal complication rate [11] as the irradiated perineal tumour bed is replaced with a fresh, highly vascularized myocutaneous pedicle. Small series have reported excellent perineal healing following VRAM reconstruction after APE for rectal cancer [9, 19] with reduced length of hospital stay [7, 9]. The current study reflects this advantage in terms of perineal healing, but there was no significant difference in length of hospital stay. The cause for this is unclear, but may reflect a protracted period of observation to ensure flap viability and societal differences regarding discharge practice. This finding has, however, been observed by other authors [20]. There was no perineal hernia in the current series, which may reflect the small patient numbers and limited
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follow-up duration as the incidence of perineal hernia following proctectomy is reported at 0.2 % with a median time to occurrence of 22 months [21]. Abdominal wall hernias, however, were more common in the VRAM group in contrast to prior series, in which there was no increase in abdominal incisional hernia after VRAM flap formation [5, 11]. However, the incidence of abdominal wall bulging and hernia observed is consistent with that reported in the literature [22]. The formation of the VRAM flap requires the sacrifice of the rectus abdominus muscle and anterior fascial sheath, which results in an abdominal wall weakness. While donor-site inlay mesh results in fewer postoperative hernias, abdominal laxity and bulging is increased [23]. Fascia-sparing VRAM flaps result in significantly fewer hernias [23] and should be preferentially used. In the current study, there was no significant difference in global health scores including physical, emotional and role function between groups. VRAM reconstruction after salvage surgery for anal cancer does not influence the recovery of sexual function in females [24]. Sexual dysfunction was high among both groups in the current study, with no particular approach affording the patient better postoperative function. This may have changed had the VRAM flap been used for vaginal reconstruction. Patients in both groups had little or no problems caring for their stoma; however, patients who did not undergo VRAM flap reconstruction reported more problems with sore skin around the stoma. The VRAM flap was always mobilized from the side contralateral to the colostomy. As the cutaneous abdominal wall innervation is consistent with a segmental, dermatomal pattern on both sides of the abdomen, nerve division is unlikely to be the cause of this difference and the reason for this finding is unclear. The CC QOL scores were in agreement with scores from the EORTC surveys. The CC scoring system is a shorter and more direct questionnaire asking patients to rate their own health, QOL and energy levels. There was no significant difference between groups in the assessed parameters lending confidence to its use in this setting. Alternatives to primary closure of the perineum following APE include biosynthetic mesh repair [20], omentoplasty [25] and myocutaneous flaps. When compared to biological mesh closure, VRAM flap use is associated with increased operative time, prolonged postoperative stay and increased cost [20]. A recent systematic review examining whether closing the perineal wound following APE with a myocutaneous flap was superior to primary repair concluded that there is some evidence for recommending a flap [26]. A further review of 255 patients following extralevator APE whose perineal wound was repaired using a flap or biological mesh concluded that there was no significant difference in outcome [27]. However, there remains a need for high-quality prospective trials to compare methods of
reconstruction to determine the long-term results, quality of life and function. This study has a number of limitations, which must be noted. The duration of follow-up between groups was not standardized and is non-significantly different. This is an important consideration in comparative studies of this nature, which may lead to a reporting bias and difficulty in interpreting comparative data. While the two groups were well matched overall, more patients in the VRAM group received neoadjuvant chemotherapy, which may reflect differences in treatment practice between the two institutions involved. Thus, the multi-centre nature of the study may have led to a degree of patient heterogeneity. Preoperative QOL data would have been beneficial for the purpose of comparison. The patient cohort is relatively small reflecting the low rate of APE in the institutions involved and may have led to a degree of selection bias. Further studies with greater numbers and standardized time intervals for assessment would help validate our results.
Conclusions Despite these limitations, this is to our knowledge the first study to examine QOL outcomes following VRAM flap reconstruction after APE for rectal cancer. Successful removal of rectal cancer is the primary goal of APE. By doing so, the patient’s life is prolonged, thus preserving patient QOL is of paramount importance. Overall, this study did not demonstrate a significant difference in patient QOL between VRAM flap and primary perineal closure after APE for rectal cancer, and further studies in this area are warranted. Conflict of interest
None.
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ORIGINAL ARTICLE
Vertical rectus abdominis myocutaneous flap and quality of life following abdominoperineal excision for rectal cancer: a multi-institutional study V. O’Dowd • J. P. Burke • E. Condon • D. Waldron • N. Ajmal • J. Deasy • D. A. McNamara • J. C. Coffey
Received: 7 May 2013 / Accepted: 12 April 2014 Ó Springer-Verlag Italia 2014
Abstract Background To obtain a clear surgical margin, abdominoperineal excision (APE) for rectal cancer frequently leaves a large perineal defect surrounded by irradiated tissue. A vertical rectus abdominis myocutaneous (VRAM) flap may facilitate healing of this wound. The current study aims to determine the effect of VRAM flap perineal reconstruction following APE on patient quality of life (QOL). Methods This is a retrospective cohort study from a prospectively collected database. Data on QOL were assessed via telephone questionnaire using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-C30, EORTC QLQ-C29 and the Cleveland Clinic QOL questionnaires. Results Twenty-seven patients underwent primary perineal closure, and 12 patients underwent a VRAM flap perineal reconstruction. The mean duration of follow-up was 16.8 months. Overall, there was no significant
difference in the Cleveland Clinic QOL score between groups (VRAM vs. no VRAM: 0.7 ± 0.2 vs. 0.7 ± 0.2, p 0.735). Patients in the VRAM group had lower levels of fatigue (5.5 ± 9.9 vs. 23.6 ± 19.2, p 0.004). Patients in the VRAM group had reduced sore skin scores around the stoma site (11.0 ± 16.2 vs. 31.8 ± 31.1, p 0.036). VRAM flap was associated with an increased incidence of abdominal wall hernia (VRAM vs. no VRAM: 25 % vs. 0 %, p 0.024). Conclusions This study is limited by its non-randomized retrospective design and relatively small sample size. A significant difference in patient QOL was not demonstrated between VRAM flap and primary perineal closure after APE for rectal cancer. Further studies in this area are warranted. Keywords Rectal cancer Abdominoperineal excision VRAM flap Quality of life
Introduction Presented in part as a poster presentation at the ASCRS Annual Meeting, San Antonio, Texas, 2–6 June 2012. V. O’Dowd E. Condon D. Waldron J. C. Coffey Departments of Colorectal Surgery, Limerick University Hospital, Limerick, Ireland e-mail: [email protected] J. P. Burke (&) J. Deasy D. A. McNamara Department of Colorectal Surgery, Beaumont Hospital, Dublin, Ireland e-mail: [email protected] N. Ajmal Department of Plastic and Reconstructive Surgery, Beaumont Hospital, Dublin, Ireland
With combined modality treatment, survival has improved for rectal cancer [1], and thus, the focus on patient quality of life (QOL) is increasingly relevant. For approximately 24 % of patients with rectal cancer, an abdominoperineal excision (APE) will be necessary for resection of the primary lesion [2]. To obtain a clear surgical margin, APE for rectal cancer frequently leaves a large perineal defect surrounded by irradiated tissue. An alternative to primary perineal wound closure after APE is myocutaneous flap reconstruction, which may be composed of gluteal [3], gracilis, latissimus dorsi [4] or rectus abdominis muscle. The vertical rectus abdominis myocutaneous (VRAM) flap contains skin,
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subcutaneous fat, a cuff of anterior rectus sheath fascia and rectus abdominis muscle. This flap brings vascularized tissue to the irradiated tumour bed, provides tissue bulk to obliterate dead space and simultaneously enables cutaneous wound closure [5]. This theoretically reduces the incidence of perineal sepsis and major perineal wound dehiscence without an increase in abdominal wall complications. The advantages of VRAM flap closure in advanced pelvic malignancy are well established [6] including recreation of a neo-pelvic diaphragm and decreasing perineal herniation [7], and some would argue that this is now the gold standard in pelvic exenterative surgery [8]. VRAM flap reconstruction has been used to close the perineal defect following APE for rectal [9, 10] and anal cancer [11] but also other abdominopelvic malignancies [12] including gynaecologic neoplastic disease [13]. Following en-bloc vaginal excision, the VRAM flap is the most common method for vaginal reconstruction [14, 15]. The effect of VRAM flap reconstruction on patient QOL after APE for rectal cancer is unknown. The current study compares QOL and surgery-related morbidity in patients who have undergone VRAM flap reconstruction or primary perineal wound closure after APE.
Materials and methods Centres This multi-institutional study was a retrospective cohort study from prospectively collected databases identifying patients in Limerick University Hospital and Beaumont Hospital who underwent APE between 1 January 2008 and 30 June 2011. Patients were eligible for inclusion if they had undergone APE for rectal cancer in Limerick University Hospital or if they had APE with VRAM flap reconstruction in Beaumont Hospital (where the routine practice is to reconstruct the perineal defect after APE with a VRAM flap). Patients were excluded if they had APE for anal cancer, were no longer alive or declined to participate. Following the approval of the institutional ethics committee, patients were identified from prospectively collated databases and additional details were obtained from operative log books, chart review and computerized records. Data recorded included patient age, sex, duration of followup, TNM stage, neoadjuvant/adjuvant treatment, length of stay and surgery-related morbidity. Based on the results of the preoperative assessment and multidisciplinary team discussion, patients underwent neoadjuvant therapy in locally advanced cases. The preoperative workup included a physical examination, colonoscopy, rigid sigmoidoscopy, magnetic resonance imaging
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of the pelvis (or endorectal ultrasound) and computed tomography of the chest, abdomen and pelvis. The majority of patients with suspected nodal involvement and/or invasion of the mesorectum underwent neoadjuvant longcourse radiotherapy (50.4 Gy over 6 weeks) with or without 5-fluorouracil-based chemotherapy. Surgery after the completion of neoadjuvant therapy was scheduled after 6 weeks. Management was concordant in both units. Five fellowship trained, colorectal surgeons performed APE using a uniform technical approach in both centres. Training was similar among all involved surgeons. The indication for APE in both institutions was that an adequate radial margin and 2-cm distal margin could not be achieved while maintaining anal sphincter complex integrity. The mesorectal plane was dissected to the level of the prostate (or below the cervix). The perineal approach was used for wide excision of the anus and distal rectum. Extralevator APE was not performed, and no supplemental omentoplasty or mesh was used to close the perineal defect. Flap reconstruction of the perineal defect was performed in the VRAM group by the same plastic surgeon (NA). This involved a skin paddle, which was designed vertically above the right rectus abdominis muscle. The inferior epigastric pedicle was mobilized to its origin, after which the flap along with its blood supply was rotated medially and transposed onto the perineal defect. With the patient in the lithotomy position, the skin paddle was marked, deepithelialized and sutured to the remnant pelvic floor. Flap skin was then sutured to perineal skin defect edges. The abdominal donor site was closed, after contralateral colostomy placement, with the aid of a prosthetic prolene mesh to support the posterior sheath. VRAM flap-assisted vaginal reconstruction was not performed in any patient. QOL tools Patients were contacted by telephone, verbal consent for participation was obtained, they were then interviewed by a single interviewer (V O’D), and QOL scores were determined. QOL was assessed using the cancer-specific questionnaire from the European Organisation for Research and Treatment of Cancer (EORTC QLQ-C30) [16] and the recently validated colorectal-specific EORTC QLQ-CR29 [17]. The Cleveland Clinic (CC) QOL score was used in addition for comparative purposes [18]. The EORTC QLQC30 consists of 30 questions that are believed to be relevant to all cancer patients; it examines aspects of QOL such as global health, physical, social and emotional functioning as well as symptoms of fatigue, pain scores and appetite disturbances. The EORTC QLQ-CR29 focuses on patients with colorectal cancer, examining aspects such as body image following stoma formation, bowel and urinary symptoms, stoma care problems and sexual function, and
Tech Coloproctol Table 1 Patient and tumour demographics
Table 2 Comparison of EORTC QLQ-C30 scores in the two groups
No VRAM (n = 27)
VRAM (n = 12)
p value
Age at surgery (years)
61.5 ± 11.0
66.7 ± 12.9
0.215
Male sex
22
7
0.232
Physical function
84.5 ± 18.5
91.5 ± 13.0
0.245
Time since surgery (months)
18.2 ± 13.8
15.2 ± 6.8
0.479
Role function
80.7 ± 25.3
81.8 ± 26.0
0.902
Emotional function
77.8 ± 20.6
85.4 ± 81.3
0.280
T1
1
0
1.000
Cognitive function
81.3 ± 22.9
77.7 ± 33.6
0.693
T2
2
1
1.000
Social function
76.9 ± 22.8
84.5 ± 22.1
0.338
T3 T4
14 10
8 3
0.494 0.714
Fatigue Nausea/vomiting
23.6 – 19.2 6.1 ± 12.2
5.5 – 9.9 2.8 ± 9.5
0.004 0.401
Pain
9.9 ± 13.2
2.8 ± 6.6
0.089
T0
3
3
0.348
Dyspnoea
6.1 ± 22.6
16.5 ± 22.2
0.194
T1
0
3
0.024
Insomnia
17.1 ± 23.1
22.0 ± 32.5
0.595
T2
3
1
1.000
Appetite loss
6.1 ± 16.0
T3
16
5
0.488
Constipation
14.7 ± 24.8
T4
5
0
0.299
Diarrhoea
12.3 ± 22.8
16.5 ± 22.2
0.593
8.6 ± 19.6
16.5 ± 26.3
0.301
Radiological T stage
Pathological T stage
Radiological N stage
Global health
Financial difficulties
No VRAM (n = 27)
VRAM (n = 12)
p value
70.4 ± 22.2
74.3 ± 18.5
0.596
0.0 ± 0.0 8.3 ± 20.5
N0
13
3
0.291
Bold values are statistically significant
N1
7
5
0.262
VRAM ventral rectus abdominus myocutaneous flap
N2
7
4
0.709
N0
12
4
0.269
N1
8
4
1.000
N2 Metastasis at presentation
7 2
4 0
0.077 1.000
1
0
2
0.089
2
12
2
0.151
3
13
8
0.322 1.000
0.196 0.438
Pathological N stage
Final stage of disease
4
2
0
Positive resection margin
0
0
–
Preoperative radiotherapy
20
12
0.077
Preoperative chemotherapy
11
10
0.034
Postoperative chemotherapy
17
7
0.728
Postoperative stay (days)
19.5 ± 13.1
19.0 ± 13.2
0.919
Perineal wound separation
9
3
0.719
Vacuum dressing for perineal wound closure
6
0
0.151
Abdominal wall hernia
0
3
0.024
Perineal hernia
0
0
–
VRAM ventral rectus abdominus myocutaneous flap
has recently been updated from the EORTC QLQ-C38 [17]. Both EORTC questionnaires focus on the patient’s experiences during the previous week. There were 4 response categories: 1 (not at all) to 4 (very much), a higher score was a positive for functional score (better function) and a negative for symptoms (more symptoms). In the CC global QOL score (or Fazio score), patients are asked to rate 3 items (perception of their own health, current quality
of health and current energy level), each on a scale of 0–10 (0, worst; 10, best). The scores were added, and the final CC global QOL utility score was obtained by dividing this result by 30 [18]. Statistic analysis All data are expressed as mean ± standard deviation (SD), and n represents the number of patients. Statistical significance between groups was determined using Fisher’s exact test for categorical variables, and analysis of variance (ANOVA) for continuous variables. p \ 0.05 was considered significant. Data were analysed using SPSS version 12.0 (SPSS, Chicago, Illinois, USA).
Results Participant and tumour demographics Over the study period, 278 patients underwent proctectomy for rectal adenocarcinoma (137 in Limerick University Hospital and 141 in Beaumont Hospital). Thirty-nine patients underwent APE and were eligible for inclusion (12 underwent VRAM flap reconstruction and 27 underwent primary perineal closure) (Table 1). All patients invited to participate did so. There was no significant difference in patient age at surgery, gender or duration of follow-up. Patients in the VRAM group more frequently had T1 tumours on final
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Tech Coloproctol Table 3 EORTC QLQ-CR29 scores between groups No VRAM (n = 27)
VRAM (n = 12)
Table 4 Cleveland Clinic quality of life scores in the two groups p value
No VRAM (n = 27)
VRAM (n = 12)
p value
Quality of life
7.2 ± 2.1
7.3 ± 1.8
0.928
Body image
73.9 ± 30.5
87.0 ± 28.1
0.213
Health
7.4 ± 2.1
7.8 ± 1.8
0.663
Anxiety
28.1 ± 29.9
16.5 ± 26.3
0.255
Energy levels
6.7 ± 2.0
7.0 ± 1.8
0.622
Weight
14.7 ± 28.1
24.9 ± 37.9
0.354
Overall score
0.7 ± 0.2
0.7 ± 0.2
0.735
Sexual interest
32.0 ± 44.8
36.4 ± 50.5
0.796
Urinary frequency
38.0 ± 23.3
45.7 ± 14.3
0.302
Blood/mucus in stool
2.4 ± 13.0
0.0 ± 0.0
0.512
Stool frequency Urinary incontinence
12.9 ± 14.7 9.8 ± 20.1
15.2 ± 21.6 19.3 ± 22.1
0.693 0.195
7.4 ± 21.3
0.0 ± 0.0
0.242
Dysuria Abdominal pain
12.2 ± 22.7
2.8 ± 9.5
0.175
Buttock pain
22.0 ± 29.0
8.3 ± 14.9
0.130
Bloating
15.9 ± 23.1
13.8 ± 17.0
0.776
Dry mouth
19.6 ± 26.3
13.8 ± 30.0
0.552
Hair loss
4.9 ± 15.0
13.8 ± 22.1
0.151
Taste
6.1 ± 20.7
16.5 ± 26.3
0.194
Flatulence
45.3 ± 27.8
63.4 ± 22.4
0.054
Faecal incontinence
30.6 ± 24.1
24.8 ± 20.5
0.473
Sore skin
31.8 – 31.1
11.0 – 16.2
0.036
Embarrassment
26.9 ± 31.8
19.4 ± 38.8
0.529
Stoma care problems Impotence/dyspareunia
4.9 ± 11.9
2.8 ± 9.5
0.588
82.2 ± 31.5
100.0 ± 0.0
0.283
VRAM ventral rectus abdominus myocutaneous flap
EORTC QLQ-CR29 Mean scores EORTC QLQ-CR29 are presented in Table 3. The patients who underwent VRAM flap reconstruction had less symptoms of sore skin around the stoma site than those who underwent primary perineal closure (11.0 ± 16.2 vs. 31.8 ± 31.1, p 0.036). None of the other symptom parameters assessed as part of the EORTC QLQCR29 showed a significant difference between groups. Cleveland Clinic QOL scores Patients were asked to rate their perception of their health, QOL and energy levels; there was no significant difference in overall Cleveland Clinic QOL score between groups as demonstrated in Table 4.
Bold values are statistically significant EORTC QLQ European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, VRAM ventral rectus abdominus myocutaneous flap
histology (3/12 vs. 0/27, p 0.024), but there was no significant difference in lymph node status or presence of metastasis at presentation. There was no significant difference in preoperative radiotherapy or postoperative chemotherapy administration; however, the VRAM group received preoperative chemotherapy more frequently (10/12 vs. 11/27, p 0.034). Postoperative length of stay was equivalent. EORTC QLQ-C30 Mean EORTC QLQ-C30 scores are presented in Table 2. There was no significant difference in global QOL score between groups with patients having similar physical, emotional, cognitive and social functioning. Patients who underwent VRAM flap reconstruction showed lower symptoms of fatigue compared to those who had primary perineal closure (5.5 ± 9.9 vs. 23.6 ± 19.2, p 0.004). All other symptom parameters assessed as part of the EORTC QLQ-C30 showed no significant difference.
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Discussion After the safe and complete removal of rectal cancer, the most important aspect of patient care is the maintenance of QOL. With the increasing incidence of rectal cancer, earlier identification and more successful treatments, patient QOL becomes increasingly relevant. The primary experience with VRAM flap perineal reconstruction in colorectal surgery is following APE for anal cancer. In this setting, the VRAM flap does not adversely affect disease-free survival, but significantly improves the perineal complication rate [11] as the irradiated perineal tumour bed is replaced with a fresh, highly vascularized myocutaneous pedicle. Small series have reported excellent perineal healing following VRAM reconstruction after APE for rectal cancer [9, 19] with reduced length of hospital stay [7, 9]. The current study reflects this advantage in terms of perineal healing, but there was no significant difference in length of hospital stay. The cause for this is unclear, but may reflect a protracted period of observation to ensure flap viability and societal differences regarding discharge practice. This finding has, however, been observed by other authors [20]. There was no perineal hernia in the current series, which may reflect the small patient numbers and limited
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follow-up duration as the incidence of perineal hernia following proctectomy is reported at 0.2 % with a median time to occurrence of 22 months [21]. Abdominal wall hernias, however, were more common in the VRAM group in contrast to prior series, in which there was no increase in abdominal incisional hernia after VRAM flap formation [5, 11]. However, the incidence of abdominal wall bulging and hernia observed is consistent with that reported in the literature [22]. The formation of the VRAM flap requires the sacrifice of the rectus abdominus muscle and anterior fascial sheath, which results in an abdominal wall weakness. While donor-site inlay mesh results in fewer postoperative hernias, abdominal laxity and bulging is increased [23]. Fascia-sparing VRAM flaps result in significantly fewer hernias [23] and should be preferentially used. In the current study, there was no significant difference in global health scores including physical, emotional and role function between groups. VRAM reconstruction after salvage surgery for anal cancer does not influence the recovery of sexual function in females [24]. Sexual dysfunction was high among both groups in the current study, with no particular approach affording the patient better postoperative function. This may have changed had the VRAM flap been used for vaginal reconstruction. Patients in both groups had little or no problems caring for their stoma; however, patients who did not undergo VRAM flap reconstruction reported more problems with sore skin around the stoma. The VRAM flap was always mobilized from the side contralateral to the colostomy. As the cutaneous abdominal wall innervation is consistent with a segmental, dermatomal pattern on both sides of the abdomen, nerve division is unlikely to be the cause of this difference and the reason for this finding is unclear. The CC QOL scores were in agreement with scores from the EORTC surveys. The CC scoring system is a shorter and more direct questionnaire asking patients to rate their own health, QOL and energy levels. There was no significant difference between groups in the assessed parameters lending confidence to its use in this setting. Alternatives to primary closure of the perineum following APE include biosynthetic mesh repair [20], omentoplasty [25] and myocutaneous flaps. When compared to biological mesh closure, VRAM flap use is associated with increased operative time, prolonged postoperative stay and increased cost [20]. A recent systematic review examining whether closing the perineal wound following APE with a myocutaneous flap was superior to primary repair concluded that there is some evidence for recommending a flap [26]. A further review of 255 patients following extralevator APE whose perineal wound was repaired using a flap or biological mesh concluded that there was no significant difference in outcome [27]. However, there remains a need for high-quality prospective trials to compare methods of
reconstruction to determine the long-term results, quality of life and function. This study has a number of limitations, which must be noted. The duration of follow-up between groups was not standardized and is non-significantly different. This is an important consideration in comparative studies of this nature, which may lead to a reporting bias and difficulty in interpreting comparative data. While the two groups were well matched overall, more patients in the VRAM group received neoadjuvant chemotherapy, which may reflect differences in treatment practice between the two institutions involved. Thus, the multi-centre nature of the study may have led to a degree of patient heterogeneity. Preoperative QOL data would have been beneficial for the purpose of comparison. The patient cohort is relatively small reflecting the low rate of APE in the institutions involved and may have led to a degree of selection bias. Further studies with greater numbers and standardized time intervals for assessment would help validate our results.
Conclusions Despite these limitations, this is to our knowledge the first study to examine QOL outcomes following VRAM flap reconstruction after APE for rectal cancer. Successful removal of rectal cancer is the primary goal of APE. By doing so, the patient’s life is prolonged, thus preserving patient QOL is of paramount importance. Overall, this study did not demonstrate a significant difference in patient QOL between VRAM flap and primary perineal closure after APE for rectal cancer, and further studies in this area are warranted. Conflict of interest
None.
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