Gracilis Muscle Interposition for the Treatment of Rectovaginal Fistula: A Systematic Review and Pooled Analysis

A rectovaginal fistula (RVF) is an abnormal epithelium-lined communication between the anorectum and the vagina and/or perineum,1 usually arising as a complication of an underlying disease process or injury. The most common cause is obstetric trauma,2 which accounts for approximately 90% of all RVFs.3 Other causes are Crohn’s disease,4,5 complications of pelvic surgery, pelvic irradiation, infections, and malignancy.

An RVF is a debilitating condition resulting in severe symptoms, psychological and physical impairment, and a profound impact on quality of life and activities of daily living. Several surgical treatment options for RVF have been described, ranging from use of biomaterials, such as plugs and fibrin glue, to anal and transperineal approaches, such as advancement flaps, episioproctotomy, and tissue interposition flaps, to abdominal procedures with bowel resection and anastomosis or permanent stoma formation.

The choice of treatment is patient-tailored and considers cause, involvement of the anal sphincter,6 patient’s characteristics, and expectations. Reports on the success rates of surgical treatments for RVF are extremely variable, and patients may require more than 1 procedure to achieve definitive closure.7,8 Therapeutic algorithms have been proposed9; however, most studies regarding RVF are retrospective case series with a limited number of patients. None of the recommendations of the latest clinical practice guidelines for the management of anal fistulas and RVF published by the American Society of Colon and Rectal Surgeons were based on high-quality evidence.10

The use of gracilis muscle interposition (GMI) for the treatment of RVF was first described by Gorenstein et al, in 1988. The length of the gracilis muscle and the location of its vascular pedicle make it particularly suitable for transposition into the rectovaginal septum as a perineal repair. GMI consists of harvesting the gracilis muscle from the medial aspect of the thigh, dividing the tendon to the knee, and transposing it into the perineal area while preserving the vascular pedicle. The muscle is placed between the rectum and the vagina, where it is sutured in place. GMI is rarely used as a first-line procedure, but it is recommended for the treatment of complex and recurrent RVFs.10 A systematic review published in 2014 by Takano et al11 on GMI for complex perineal fistulas reported a success rate ranging between 0% and 100%. Hotouras et al,12 in a systematic review of 17 studies comprising 106 patients who underwent GMI for the treatment of RVF and pouch-vaginal fistulas, reported a 33% to 100% success rate.

The objective of the present systematic review is to summarize the currently available data on the efficacy of GMI for RVF with the aim of providing more robust evidence to aid the decision-making process when dealing with complex, persistent, and recurrent RVFs.

MATERIALS AND METHODS

A systematic literature search was conducted on March 16, 2022, and reported according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines and the proposed guidelines for reporting Meta-analyses of Observational Studies in Epidemiology (MOOSE).13,14 Our protocol was registered in PROSPERO (CRD42022319621).

Data Sources and Search Strategy

A literature search including MEDLINE, Embase, the Cochrane Library, and Web of Science was performed by the investigators. The search strategy included the text terms “fistul*” and “gracil*” in “All fields” and the related MeSH terms. No language or date restrictions were applied. The reference lists of the selected studies and of previous systematic reviews were searched manually to identify all pertinent articles.

Inclusion and Exclusion Criteria and Study Selection

Randomized controlled trials, prospective cohort studies, case–control studies, retrospective cohort studies, and case series including adult patients (aged 18 years or older) undergoing GMI for the treatment of rectovaginal fistulas were included. Studies were excluded according to the following criteria: 1) articles with less than 5 adult patients who underwent GMI for RVF; 2) articles in which the primary success rate of GMI for the treatment of the population of interest could not be retrieved from the full text or by contacting the authors; 3) reviews, guidelines, book chapters, and editorials. Conference abstracts were included if the reported data were considered sufficient as recommended by Scherer et al.15

The identified abstracts were independently screened by 2 reviewers (A.O.P. and M.M.). The full-text review of potentially eligible studies was conducted independently by 2 reviewers (A.O.P. and M.M.). In case of disagreement between the reviewers, a final decision was made with the senior authors (T.L.H. and S.R.S.).

Data Extraction and Synthesis

Data from the included studies were extracted using a structured REDCap form.16,17 Data included characteristics of the study (study design, setting, time period), patient demographics (age, BMI, time between diagnosis and GMI, number of previous procedures, RVF cause), perioperative data (operative time, length of hospital stay, stoma presence, early postoperative complications), and long-term outcomes (follow-up, success rate, definition of success rate, rate of stoma closure, success rate after subsequent procedures, quality of life, fecal continence, sexual function). Data extraction was performed by one author and verified by another. Data were summarized in a narrative synthesis using descriptive statistics when appropriate.

The quality of evidence for each study was rated using the Oxford Centre for Evidence-Based Medicine 2011 Levels of Evidence Table.18

The risk of bias was independently assessed by 2 reviewers (A.O.P. and M.M.) using the Methodological Index for Nonrandomized Studies (MINORS) tool.19 Any divergence in the risk of bias evaluation was resolved by consensus.

Statistical Analysis

Statistical analyses were performed with MetaXL (EpiGear International Pty Ltd., Sunrise Beach, Australia, version 5.3). Pooled success rates with 95% CIs were calculated with the inverse variance method. A subgroup analysis of success rate, including only studies with at least 11 patients who underwent GMI for RVF, was also performed. In case only the median and range were available, this was converted to mean and SD using the method described by Wan et al.20

In addition, we conducted a random-effects meta-analysis with the inverse variance method, including studies that compared GMI for Crohn’s disease versus other causes.

Heterogeneity between studies was assessed with the Cochrane Q test and I2 statistics. A random-effects model was used to calculate the pooled success rate if significant heterogeneity was detected (p < 0.1 and I2 > 50%). A fixed-effects model was used if a p value was >0.1 and I2 <50%. The Doi plot and Luis Furuya-Kanamori asymmetry index were used to check for publication bias.

RESULTS

After removal of duplicates, 662 records were screened and 68 were sought for full-text retrieval. Twenty studies were included (Fig. 1).21–40

F1FIGURE 1.:

PRISMA flow diagram of study screening and selection. PRISMA = Preferred Reporting Items for Systematic review and Meta-Analysis.

The characteristics of the included studies are reported in Table 1.21-40 Of the 20 included studies, 19 were case series (18 retrospective, 1 prospective), whereas 1 was a prospective cohort study. Six studies (30%) included only our population of interest21–26; 11 studies (55%) also included other types of fistulas27–37 and 3 studies (15%) also included other interventions.38–40 The risk of bias evaluation is reported in Table 2 and Supplemental Figure 1 at https://links.lww.com/DCR/C146. The funnel plot and DOI plot of the included studies are shown in Supplemental Figures 2 at https://links.lww.com/DCR/C147 and 3 https://links.lww.com/DCR/C148.

TABLE 1. - Characteristics of the included studies Author, year Country Study design Study period Single center Total number of patients in the study Total number of patients included in the review Age (y) BMI (kg/m2) Cause No. of previous repairs Time between diagnosis and GMI Cannom, 201340 United States Retrospective case series 1992–2011 No, bicentric 41 20 Median 45 (range, 18–84) Obstetric injury and CD 32/41 patients (78%) had previous failed repairs (range, 1–8) Chen, 201332 China Retrospective case series May 2009–March 2012 Yes 19 11 Median 47 (range, 16–80) Median 21.9 (range, 15.6–29.1) Rectal cancer = 4
GYN surgery = 3
Obstetric injury = 3
Pelvic injury = 1 Mean 1 (range, 0–3) Corte, 201539 France Retrospective case series 1996–2014 Yes 79 32 Mean 43 ± 16 (range, 18–82) Mean 24 ± 4 (range, 17–39) CD = 34
Anastomotic leakage = 25
Obstetric injury = 7
Radiation proctitis = 4
Unknown = 4
Pelvic cancer = 2
Diverticulitis = 2
Trauma = 1 Elliott, 201427 United States Retrospective case series 2003–2013 Yes 18 7 Frontali, 202128 Italy, France Retrospective case series 2003–2019 No, bicentric 61 51 Mean 42 ± 12 (range, 24–72) CD = 29
Cancer = 4
Obstetric = 9
Trauma = 9 Mean 2.4 ± 1.7 (range, 0–8) Mean 59 ± 59 mo (0–252) Grott, 202130 Germany Retrospective case series 2006–2016 Yes 46 28 51.5 (range, 26–74) Obstetric = 8
CD = 9
Low anterior resection = 6
Iatrogenic = 2
Idiopathic = 3 Median 2 (range, 2–11) Hull, 202131 United States Retrospective case series January 2009–August 2020 Yes 22 20 Median 43 (range, 19–64) Median 31 (range, 22–51) Obstetric = 5
CD = 3
GYN procedure = 3
Pelvic radiation = 2
Anal/vaginal abscess = 2
Other = 6 Median 3 (range, 1–6) Kersting, 201921 Germany Retrospective case series January 2011–December 2016 Yes 19 19 Mean 48 (range, 20–79) BMI >35 in 2 (11%) patients CD = 6
Pelvic surgery = 8
Radiation = 1 Idiopathic = 4 Mean 4 (range, 1–15) Mean 2.5 y (range, 2 wk–15 y) Kharoub, 202122 Egypt Prospective case series June 2015–May 2020 No, bicentric 23 23 Mean 43.6 ± 10.16 Obstetric = 18
IBD = 4 Unspecified = 1 <6 mo for 7 patients, 6–12 mo for 6 patients, 12–24 mo for 8 patients, and >24 mo for 2 patients Korsun, 2019*33 Germany Retrospective case series January 2000–May 2018 No, bicentric 32 23 Mean 39 (range, 24–55) CD Mean 2 (range, 1–25) Kulkarni, 201623 India Retrospective case series February 2003–May 2014 Yes 30 30 Mean 36.7 (range, 21–59) Patients with fecal incontinence Lefèvre, 200924 France Retrospective case series April 2003–November 2006 Yes 8 8 39 (range, 26–63) Median 20 (range,5–24) Obstetric = 1
CD = 5
Perineal surgery (Sullivan procedure, Burch procedure) = 2 3 (range, 1–6) Mean 15 y (range, 7–30) Nassar, 201125 Egypt Retrospective case series 2002–2009 Yes 11 11 Mean 49 ± 4.72 (range, 25–72) Pelvic surgery = 11 (hysterectomy = 5;
low anterior resection = 3;
vulvectomy and partial vaginectomy = 1;
vaginal resection = 1;
pelvic exenteration = 1) 2 (range, 1–4) Park, 201726 Korea Retrospective case series January 2009–July 2016 Yes 11 11 Mean 46.36 ± 14.02 Mean 23.08 ± 3.21 Obstetric = 1
CD = 2
Ulcerative colitis = 1
Pelvic surgery = 7
GIST = 1 2.18 ± 1.17 Picciariello, 202029 Italy Retrospective case series June 2003–April 2017 Yes 14 9 Median 48 (range, 29–76) Obstetric = 2
CD = 3
Pelvic surgery = 3
Enema trauma = 1 2 (range, 1–3) Rottoli, 201834 Italy Prospective cohort study 2005–2016 Yes 21 14 Median 45 (range, 25–66) Obstetric = 3
CD = 8
Pelvic surgery = 1
Idiopathic = 1 1.5 Mean 3.9 y (range, 1–16) Ryoo, 201938 Korea Retrospective case series 1998–2016 Yes 92 7 Median 49 (range, 16–80) Obstetric = 1
CD = 3
Pelvic surgery = 1 (low anterior resection)
Radiation = 2 1 Troja, 201335 Germany Retrospective case series January 2004–June 2010 Yes 10 6 Mean 40.2 ± 6.5 CD = 1
Pelvic surgery = 4 (3 for rectal cancer, 1 GYN surgery)
Idiopathic = 1 1 (1), 2–3 (5) Ulrich, 200936 Germany Retrospective case series 2003–2008 Yes 35 9 Mean 58 (range, 38–78) CD = 3
Pelvic surgery = 6 (2 for rectal cancer, 4 for cervical cancer) 1 (21), 2–5 (4) Mean 21.3 mo (range, 6–51) Yellinek, 202137 United States Retrospective case series January 2000–June 2018 Yes 119 45 Median 47 (range, 21–77) Mean 26.82 ± 4.2 Mean 2.2 (range, 0–8)

CD = Crohn’s disease; GIST = GI stromal tumor; GMI = gracilis muscle interposition; GYN = gynecologic.


TABLE 2. - Risk of bias evaluation Author, year Level of evidence A clearly stated aim Inclusion of consecutive patients Prospective collection of data End points appropriate to the aim of the study Unbiased assessment of the study end point Follow-up period appropriate to the aim of the study Loss to follow-up less than 5% Prospective calculation of the study size Adequate control group Contemporary groups Baseline equivalence of groups Adequate statistical analyses Total Cannom 201340 IV 2 2 1 2 2 2 0 0 11 Chen, 201332 IV 2 2 2 2 2 2 2 0 14 Corte, 201539 IV 2 2 2 2 2 2 0 0 12 Elliott, 201427 IV 2 2 1 2 2 2 0 0 11 Frontali, 202128 IV 2 2 2 2 2 1 2 0 13 Grott, 202130 IV 2 2 1 2 2 2 2 0 13 Hull, 202131 IV 2 2 1 2 2 1 0 0 10 Kersting, 201921 IV 2 0 1 2 2 2 0 0 9 Kharoub, 202122 IV 2 1 2 2 2 2 0 0 11 Korsun, 201933 IV 2 0 1 2 2 2 0 0 9 Kulkarni, 201623 IV 2 2 1 2 1 1 0 0 9 Lefèvre, 200924 IV 2 2 2 2 2 2 2 0 14 Nassar, 201125 IV 2 2 2 2 2 2 2 0 14 Park, 201726 IV 2 2 2 2 2 2 2 0 14 Picciariello, 202029 IV 2 2 2 2 0 1 2 0 11 Rottoli, 201834 II 2 2 2 2 2 2 2 0 2 2 2 2 22 Ryoo, 201938 IV 2 2 2 2 2 1 0 0 11 Troja, 201335 IV 2 2 2 2 2 2 2 0 14 Ulrich, 200936 IV 2 2 2 2 2 2 2 0 14 Yellinek, 202137 IV 2 2 2 2

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