World J Surg (2014) 38:3097–3104 DOI 10.1007/s00268-014-2722-9

SCIENTIFIC REVIEW

Primary Fascial Closure With Laparoscopic Ventral Hernia Repair: Systematic Review Duyen H. Nguyen • Mylan T. Nguyen • Erik P. Askenasy • Lillian S. Kao • Mike K. Liang

Published online: 22 August 2014 Ó Socie´te´ Internationale de Chirurgie 2014

Abstract Laparoscopic ventral hernia repair (LVHR) has grown in popularity. Typically, this procedure is performed with a mesh bridge technique that results in high rates of seroma, eventration (bulging), and patient dissatisfaction. In an effort to avoid these complications, there is growing interest in the role of laparoscopic primary fascial closure with intraperitoneal mesh placement. This systematic review evaluated the outcomes of closure of the central defect during LVHR. A literature search of PubMed, Cochrane databases, and Embase was conducted using PRISMA guidelines. MINORS was used to assess the methodologic quality. Primary outcome was hernia recurrence. Secondary outcomes were surgical-site infection, seroma formation, bulging, and patient-centered items (satisfaction, chronic pain, functional status). Eleven studies were identified, eight of which were case series (level 4 data). Three comparative studies examined the difference between closure and nonclosure of the fascial defect during laparoscopic ventral incisional hernia repairs (level 3 and 4 data). These studies suggested that primary fascial closure (n = 138) compared to nonclosure (n = 255) resulted in lower recurrence rates (0–5.7 vs. 4.8–16.7 %) and seroma formation rates (5.6–11.4 vs. 4.3–27.8 %). Follow-up periods for both groups were similar (1–108 months). Only one study evaluated patient function and clinical bulging. It showed better outcomes with primary fascial closure. Closure of the central defect during LVHR resulted in less recurrence, bulging, and seroma than nonclosure. Patients with closure were more satisfied with the results and had better functional status. The quality of the data was poor, however. A randomized controlled trial to evaluate the role of closure of the central defect during LVHR is warranted.

Introduction Ventral hernias are common, challenging surgical problems. It is estimated that up to 20 % of abdominal surgeries performed annually in the United States develop a ventral

D. H. Nguyen
M. T. Nguyen
L. S. Kao
M. K. Liang (&) Department of Surgery, University of Texas Health Science Center, 5656 Kelley Street, Houston, TX 77026, USA e-mail: [email protected]; [email protected] E. P. Askenasy Baylor College of Medicine, Houston, TX, USA

incisional hernia [1], The results of the ventral hernia repair are imperfect, with high rates of wound complications and hernia recurrence [2–9]. Controversy still exists regarding which surgical technique is best for ventral hernia repair. Although laparoscopic hernia repair has yielded lower rates of surgical-site infections (SSIs) and hospital stays, rates of wound complications and hernia recurrence have not improved [10, 11]. In addition, standard laparoscopic repair with bridging of the facial defect is sometimes associated with bulging or clinical eventration [12, 13]. The role of primary fascial closure prior to mesh placement has recently been of interest as an additional step during laparoscopic ventral

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hernia repair. Primary fascial closure of the hernia defect attempts to recreate a functional, dynamic abdominal wall while eliminating the dead space. This study evaluated the outcomes of primary fascial closure during laparoscopic ventral hernia repair with meshthat have been reported in the literature. We hypothesized that primary fascial closure would provide better outcomes than the standard bridging repair.

Methods

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outcomes (including patient satisfaction, chronic pain, and functional status). Data extraction The selected articles were reviewed, and the primary and secondary outcome data were extracted. Study design, number of patients, patients’ ages, operation time, hospital stay, follow-up period, and conversion from laparoscopic to open repair were also recorded. For comparative studies, the number of patients with or without fascial closure was noted.

Search strategy Results A search of PubMed, Cochrane Central Register of Controlled Trials, and Embase was performed to identify the articles for this review in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) [14]. The search included publications from January 1990 through October 2013. Clinicaltrials.gov was checked for ongoing trials. The search strategies were laparoscopic AND (ventral or incisional) AND hernia. Reference lists of the chosen articles were reviewed for additional articles. If there were overlapping data from the same authors, the most recent report was included in the review. Studies were included if they were human-related, in English, and evaluated primary fascia closure during laparoscopic ventral hernia repair. Systematic reviews, meta-analyses, commentaries, editorials, pediatric studies, and nonventral hernia (e.g., inguinal, hiatal) repairs were excluded. Articles that did not discuss defects or fascia closure were excluded. Studies were excluded if there were fewer than 10 cases reported. Evaluation of articles The Methodological Index of Nonrandomized Studies (MINORS) was used to evaluate the methodologic quality and potential bias of the articles selected for this review [15]. The first 8 of the 12 items evaluated noncomparative studies. The last 4 items applied to comparative studies. Items were scored on a 3-point scale: 0 (not reported), 1 (reported but inadequate), or 2 (reported and adequate). The global ideal score for noncomparative studies was 16. It was 24 for comparative studies. Two independent reviewers scored the articles based on the criteria listed by the assessment. Any disagreement or discrepancies were resolved by consensus among the authors.

The search resulted in 1,421 titles and abstracts (Fig. 1). After screening, 28 full-text articles were reviewed, with 17 of them ultimately excluded. A total of 11 articles met the inclusion criteria. They were then subjected to MINORS for assessment and were included in the systematic review. Quality of the studies No randomized controlled trials met inclusion criteria for this literature search. There were five retrospective studies, which included three comparative studies. Only one of the comparative studies was risk-adjusted. The remaining studies were prospective case series. One study did not report the follow-up period. Based on the MINORS criteria, the studies included in the review are limited by inadequate description of follow-up, lost to follow-up, bias, and sample size calculations (Table 1). Only one study used the outcome definition of SSI established by the Centers for Disease Control and Prevention. Studies with closure of primary fascia Pooled results from the studies (n = 11) reporting closure of the fascial defect (n = 1,849) had patient ages ranging from 19 to 100 years. The follow-up period ranged from 1 to 141 months. Patient characteristics are shown in Table 2. Recurrence rates with closure of the central defect ranged from none to 7.7 %. The rates of bulging and SSIs were 0 to 8.3 %. Closure was associated with seroma formation rates of 0 to 11.4 % (Table 1). Studies with adequate follow-up

Primary and secondary outcomes The primary outcome measure was the recurrence rate of laparoscopic ventral hernia repairs. Secondary outcomes were bulging, SSI, seroma formation, and patient-centered

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Only three studies had a minimum follow-up of 6 months or more. The follow-up of these three studies ranged from 7 to 84 months. No recurrences were reported in these three studies. The seroma formation rate ranged from 0 to 8.3 %.

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Fig. 1 Search flow chart

Studies with comparison of nonclosure versus closure Three comparative studies examined the difference between closure and nonclosure of the fascial defect in laparoscopic ventral incisional hernia repairs [2, 16, 17]. Ages in the nonclosure group (n = 255) ranged from 26 to 91 years, and follow-up ranged from 1 to 108 months. In the closure group (n = 138), ages ranged from 21 to 71 years, and follow-up ranged from 1 to 108 months. The recurrence rate ranged from 4.8 to 16.7 % in the nonclosure group and from 0 to 5.7 % in the closure group. Seroma formation rate ranged from 4.3 to 27.8 % in the nonclosure group and from 5.6 to 11.4 % in the closure group. Zeichen et al. performed a retrospective study that compared nonclosure (n = 93) to closure of the primary fascia (n = 35). The mean follow-up period was 26 months (1–108 months). The study used both percutaneous (n = 18) and intracorporeal (n = 17) closure of the defect. The nonclosure group had 15.1 % recurrence rate. Two cases of recurrence appeared in the percutaneous closure group. The seroma formation rate was 4.3 % in the nonclosure group and 11.4 % in the closure group. The study did not report a definition for the outcomes. Banerjee et al. reported a retrospective study that compared nonclosure (n = 126) to closure (n = 67) of the defect. The mean follow-up period was 10.5 months (1–36 months). The follow-up period was the shortest of the three comparative studies. The recurrence rate was 4.8 % in the nonclosure group and 3.0 % in the closure group.

Clapp et al. reported a retrospective study that examined the outcomes of defect closure. It was the only study that was risk-adjusted with minimum follow-up criteria. The median follow-up period was 24 months (7–34 months). In the nonclosure group (n = 36), the recurrence rate was 16.7 %. The closure group (n = 36) experienced no recurrences. Bulging rate was 69.4 % in the nonclosure group and 8.3 % in the closure group. SSI rate was 13.9 % in the nonclosure group and 8.3 % in the closure group. Seroma formation rate was 27.8 % in the nonclosure group and 5.6 % in the closure group. Clapp et al. also reported on patient-centered outcomes. The mean ± SEM patient satisfaction and functional status rates were higher in the closure group than in the nonclosure group: 8.8 ± 0.4 vs. 7.1 ± 0.5 and 79 ± 2 vs. 71 ± 2, respectively. Patient satisfaction was based on a 10-point Likert-type scale, with 1 indicating least satisfied and 10 most satisfied. Functional status was assessed using the Activities Assessment Scale (AAS). Primary fascial closure techniques The techniques for closure varied (Table 3). Overall, two studies used intracorporeal closure only, seven studies utilized an extracorporeal technique, and two studies had a mixed technique. Studies utilizing both techniques did not describe any additional risks or benefits of either technique or selection criteria for using either technique. The most commonly described technique was an extracorporeal suturing, wherein small incisions were made following which a suture passer was used to close the defect. Most

123

123

2013

2012

2012

2012

2012

2011

2009 2008

2007

2007

2004

Zeichen [16]

Allison [23]

Banerjee [17]

Clapp [2]

Rea [22]

Orenstein [18]

Agarwal [24] Agarwal [12]

Palanivelu [19]

Chelala [20]

Franklin [21]

Prospective

Prospective

Prospective

Prospective Prospective

Retrospective

Prospective

Retrospective

Retrospective

Retrospective

Retrospective

Study type

10

11

12

12 12

12

9

21

16

12

20

MINORS index

36

Closure

Closure

Closure

Closure Closure

Closure

384

400

721

29 30

47

87

Closure Closure

36

67

Closure Nonclosure

126

Nonclosure

13

35

Closure Closure

93

No.

Nonclosure

Technique

11 (2.9 %)

6 (1.5 %)

4 (0.6 %)

0 0

0

0

0

6 (16.7 %)

2 (3.0 %)

6 (4.8 %)

1 (7.7 %)

2 (5.7 %)

14 (15.1 %)

Recurrence

–

–

–

0 0

0

–

3 (8.3 %)

25 (69.4 %)

–

–

–

–

–

Bulging

Results are given as the mean ± SEM

**Assessed using Activities Assessment Scale (AAS)

*Assessed using a 10-point, Likert-type scale

a

F/U follow-up, MINORS Methodological Index of Nonrandomized Studies, SSI surgical-site infection

Year

Study

Table 1 Study characteristics and outcomes

–

–

–

0 –

0

3 (8.3 %)

5 (13.9 %)

–

–

0

–

–

SSI

12 (3.1 %)

8 (2.0 %)

55 (7.6 %)

– 0

0

0

2 (5.6 %)

10 (27.8 %)

–

–

0

4 (11.4 %)

4 (4.3 %)

Seroma

–

–

–

– –

–

–

8.81 ± 0.36

6.96 ± 0.53

–

–

–

–

–

Patient satisfactiona,*

–

–

–

– –

–

–

79.06 ± 1.94

71.26 ± 2.26

–

–

–

–

–

Functional statusa,**

47 (1–141)

28 (1–57)

50 (3–120)

34 (19–43) 58 (26–84)

16 (3–36)

–

24 (7–34)

10 (1–36)

23 (2–33)

26 (1–108)

Mean F/U (months)

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Closure

Franklin [21]

-

-

721 (100 %)

-

-

18 (38.0 %)

87 (100 %)

28 (77.8 %) 28 (77.8 %)

-

-

-

-

-

1.96 (0–8) mean (range)

-

2 (median) 2 (median)

-

-

-

–

Number of prior abdominal surgeries

-

35 (23–48)

-

-

27 (20–39)

31.8 (22–50)

-

31.6 (1.1) 34.2 (1.4)

35.6 (9.8)

31.5 (4.4)

31.7 (21–71)

30.2 (20–52)

BMI (kg/m2)

-

-

-

7 (23.3 %)

17 (58.6 %)

8 (17.0 %)

-

14 (38.9 %) 10 (27.8 %)

-

-

-

-

DM

BMI body mass index, DM diabetes mellitus, COPD chronic obstructive pulmonary disease, ASA American Society of Anesthesiologists

BMI and ASA scores are reported as the mean (range) or the mean (SD) unless otherwise noted

Closure

Closure

Chelala [20]

Closure

Agarwal [12]

Palanivelu [19]

Closure

Closure

Orenstein [18]

Closure

Rea [22]

Agarwal [24]

Nonclosure Closure

Clapp [2]

59 (30.6 %)

11 (84.6 %)

Closure

Nonclosure and closure

Allison [23]

Banerjee [17]

11 (11.8 %) 6 (17.1 %)

Nonclosure

Zeichen [16]

Number of patients with prior abdominal surgery

Closure

Technique

Study

Table 2 Previous surgeries and co-morbidities of included studies

-

-

-

11 (36.7 %)

11 (37.9 %)

5 (11.0 %)

-

6 (16.7 %) 9 (25.0 %)

-

-

-

-

COPD

-

-

-

-

7 (24.1 %)

2 (4.0 %)

-

15 (41.7 %) 12 (33.3 %)

-

-

-

-

Smoker

-

-

-

-

-

-

(1–3)

2.6 (1–4) 2.8 (1–4)

2.5 (1–4)

3 (median) (2–3)

2.24 (1–4)

2.3 (1–4)

ASA score

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Table 3 Closure technique Study

Defect closure

Suture type

Mesh type

Defect size (cm2)

Incisional

Zeichen [16]

Intracorporeal and extracorporeal

Braided

Prosthetic

43.97 (9–225)

10 (28.6 %)

Allison [23]

Intracorporeal

Nonbraided

Gore-Tex dual mesh, Physiomesh, Parietex, Veritas

37.39 ± 35.6

13 (100 %)

Banerjee [17]

Extracorporeal

Nonbraided

Polyester (Parietex)

41.2 (1–5,000)

52 (77.6 %)

Clapp [2]

Extracorporeal

Nonbraided

Polypropylene, polyester, PTFE

28.2 ± 6.39

28 (78.8 %)

Rea [22]

Extracorporeal

Nonbraided

Gore Dualmesh

Defects of a wall whose major axis was \10 cm or minor and multiple defects on an axis B12 cm

87 (100 %)

Orenstein [18]

Extracorporeal

Nonbraided

Polypropylene, polyester

82 (16–300)

18 (38.2 %)

Agarwal [24]

Extracorporeal

Nonbraided

PTFE

9.6 cm (length)

16 (55.1 %)

Agarwal [12]

Extracorporeal

Nonbraided

PTFE

5.7 cm (length)

8 (26.7 %)

Palanivelu [19]

Intracorporeal

Nonbraided

Bilayered mesh

96 (11–128)

721 (100 %)

Chelala [20]

Intracorporeal and extracorporeal

Nonbraided

Polyester (Parietex)

Axial size of defect \14 cm

72 (60 %)

Franklin [21]

Extracorporeal

Nonbraided

Polypropylene, Surgisis, Gore-tex, composite

–

240 (62.5 %)

PTFE: polytetrafluoroethylene

commonly it was performed with simple interrupted sutures, U-stitches, and occasionally running sutures. Most authors reported that the fascial layer could be routinely closed for defects 6 to 10 cm wide [2, 12, 16–24]. The largest defect that was closed measured 12 cm [2]. Other studies One article described robot-assisted ventral hernia repair. Allison et al. [23] utilized the da Vinci robot for closing the fascial defect prior to mesh fixation. The hernia repair was performed with intracorporeal primary closure of the fascial defect followed by underlay mesh fixation. There was no report of an SSI, mesh infection, seroma, or chronic pain among the 13 patients who underwent closure of the defect. The recurrence rate was 7.7 %.

Discussion Primary fascial closure during laparoscopic ventral hernia repair with mesh showed promising results. When compared to the standard laparoscopic ventral hernia repair with mesh, primary fascial closure appears to yield lower rates of both hernia recurrence and clinical bulging. It also causes no increase in the SSI rate. The data that support these findings, however, are of low quality, and risk of bias is high. Use of laparoscopic techniques for hernia repair has lowered SSI rates and decreased the length of hospital stay

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[10, 11]. Laparoscopy application, however, is limited by the procedures that are amenable to its adaptation and the outcomes. Many hernia repairs cannot be undertaken laparoscopically because of extensive adhesions, large hernial defects, and the level of contamination. Also, laparoscopic surgery has not improved hernia recurrence rates or decreased the overall wound complication rates [2–5]. Primary fascial closure is recommended for quality hernia repair [25]. Unlike groin hernias where the margins of repair are fixed structures and ‘‘tension-free’’ makes physiologic sense, the ventral abdominal wall exists under constant physiologic tension with mobile margins. Failure to return the abdominal wall to its normal anatomic position risks a nonfunctional abdomen [19]. Primary fascial closure restores normal anatomy by reapproximating the abdominal wall under physiologic tension, which may restore its function and prevent bulging. Given LaPlace’s law, a central nonfunctional portion of the abdominal wall acts like a ‘‘sail in the wind’’ and is prone to bulge [26]. Also, by eliminating the dead space, the incidence of seromas and wound complications may be decreased. Primary fascial closure using laparoscopic ventral hernia repair with mesh may decrease the hernia recurrence rate. Closing the fascial defect allows wider lateral mesh overlap, which may explain this finding. Most mesh for laparoscopic ventral hernia repair comes in standard sizes. For example, a 15 9 20 cm piece of mesh might be chosen to allow at least 5 cm of mesh overlap during repair of a 5 9 8 cm hernial defect. With primary fascial closure, the

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mesh would overlap 7.5 cm in each lateral direction and 6.0 cm in the vertical direction. No study has been able to assess the superiority of various fascial closure methods. In theory, extracorporeal and intracorporeal closures of a defect have advantages and disadvantages. Extracorporeal suturing allows closure of large defects and complete desufflation of the abdomen while tying the sutures, minimizing tension on the suture line. However, percutaneous closure requires multiple punctures in the skin and may increase the risk of an SSI and suture granuloma. Using interrupted sutures allows step-wise closure of the defect with the abdomen completely desufflated, reducing tension for progressive suturing. Alternatively, running sutures have been shown to be more beneficial for open closure, with decreased operative times and fewer suture granulomas. Whether these benefits indicate that laparoscopic primary fascial closure is the better procedure remains to be seen. Not all ventral hernias are amenable to or appropriate for fascial closure during laparoscopic repair. Size plays a substantial role. For small defects, particularly Swiss-cheese type defects, fascial closure may not be warranted unless a single defect is large (C3 cm wide) [2, 27, 28]. Closure of defects [6 to 10 cm wide can be challenging. The largest defect reported being closed was 12 cm wide [2, 27]. Although there is no accepted way to evaluate abdominal compliance and elasticity in the clinical setting, easily distendable abdominal walls are more amenable to primary fascial closure. Anecdotally, some believe that this is related to a patient’s body mass index (lower), sex (female), and age (older). Defect location may influence the feasibility of primary fascial closure. Hernias adjacent to fixed structures (e.g., epigastric hernias, suprapubic hernias) may be less amenable to fascial closure. Finally, defect closure may not be necessary in all patients. For example, patients with poor underlying functional status caused by co-morbidities may not be candidates for closure. The results of this review have important clinical implications. Fascial closure techniques with subsequent mesh fixation have lower recurrence rates and seroma formation than hernia repairs that bridge the fascial defect. A randomized controlled trial to evaluate the role of closure of the central defect during laparoscopic ventral hernia repair is warranted (n = 20 for eventration or n = 220 for recurrence, a = 0.05, b = 0.20). The technique that should be examined in the trial should include intracorporeal closure using nonabsorbable suture. The review is limited because of the quality of the available literature. The vast majority of the literature pertaining to hernia is level IV case series. This low-quality evidence provides little to no guidance when choosing the best therapy. For our search—primary fascial closure with laparoscopic ventral hernia repair with mesh—the

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literature search yielded few comparative studies and only one risk-adjusted comparative study. There was inconsistency of the outcome definitions among the studies. Our literature search suggests that primary fascial closure in conjunction with laparoscopic ventral hernia repair is safe and may provide superior outcomes with decreased recurrence rates, seromas, and bulging (grade C recommendation). Further case series and retrospective reviews on this subject are not needed. Future studies should focus on riskadjusted comparative studies, particularly appropriately powered prospective randomized clinical trials.

Conclusions Despite the limited comparative literature, primary fascial closure with laparoscopic ventral hernia repair appears promising. Indeed, its use may result in lower rates of eventration (bulging), recurrence, and seroma formation. Also, patients appear to be more satisfied with the results and have improved functional status compared to a bridged repair. A prospective, randomized controlled trial is warranted.

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