A Systematic Review of Epidemiology and Outcomes Associated with Local Surgical and Intersphincteric Ligation Procedures for Complex Cryptoglandular Fistulas

Literature Search

The electronic search returned 514 articles; an additional 68 were identified from a manual search of other sources; 121 duplicates were deleted. Of the 461 records screened on the basis of titles and abstracts, we included 316 in the full-text assessment. Of those, 149 were excluded on the basis of inclusion/exclusion criteria. CF were assessed in 148 studies (PRISMA flow diagram, Fig. 1). Of these, two studies reported the incidence/prevalence of CF [9, 10]. Owing to the large volume of studies identified (n = 43) that reported outcomes of local surgical treatments and intersphincteric ligation procedures, the current synthesis is limited to those published on CCF between January 1, 2015 and March 25, 2020 (n = 18). Details of the studies are included in Table 1. Results from combined surgical procedures (e.g., mucosal anal flap [MAF] combined with injection of platelet-rich plasma) were out-of-scope; however, fistulotomy and primary sphincteroplasty (FIPS) was included because the two techniques are essentially two steps of a single procedure. Criteria for what comprised a complex fistula were determined by each respective study author and are included in Table 1.

Fig. 1figure 1Table 1 Characteristics of included studies of local surgical procedures (n = 10) and intersphincteric ligation (n = 8) included in the SLRRisk of Bias Assessment

Of the 18 included outcomes studies, 17 were cohort studies or case series that met the review definition for cohort studies. Of these, seven studies were prospective [11,12,13,14,15,16,17] and 10 were retrospective [18,19,20,21,22,23,24,25,26,27]. One study was a retrospective cross-sectional study [28]. Two papers [20, 21] were judged as having a serious risk of bias and 16 as having a moderate risk of bias (Table 1).

Epidemiology of CF

Two studies from the UK estimated incidence or prevalence of CF; a population-based study using The Health Improvement Network (THIN) UK primary care database estimated the prevalence of CF in patients without Crohn’s disease at 1.35/10,000 patients in 2017 in the UK, down from 1.83/10,000 patients in 2014. The standardized prevalence of CF in the EU in 2017 was 1.39 (1.26–1.52) per 10,000. The authors suggest that the declining fistula prevalence could be an artifact of a decline in active patients in the database [9]. Another study examined the incidence of anal fistula among patients with a hospital admission for anal abscess in the Hospital Episode Statistics database, an administrative data set with almost complete capture of all hospital episodes in England since its inception in 1987. The authors reported that 52.6% (95% CI 51.6% to 53.0%) of patients without inflammatory bowel disease progressed from anorectal abscess to fistula over 12 months [10]. No studies were identified estimating the incidence or prevalence of CCF specifically.

Clinical Outcomes of Selected Surgical Procedures for CCF

The studies identified in this review described clinical outcomes of healing, recurrence, FI, and pain following local surgical procedures and intersphincteric ligation procedures for CCF. Local surgical procedures included MAF (n = 6), fistulectomy (n = 3), FIPS, (n = 1), and modified Parks’ technique (n = 1). No studies were identified performing lay open fistulotomy. Intersphincteric ligation procedures included LIFT or BioLIFT (n = 7) and TROPIS (n = 1). Outcomes are summarized in Tables 2 and 3.

Table 2 Selected outcomes of local surgical procedures for complex cryptoglandular fistulasTable 3 Selected outcomes of intersphincteric ligation procedures for complex cryptoglandular fistulasFistula Healing (Surgical Success)

Fourteen of 18 studies (seven local surgical and seven intersphincteric ligation studies) reported on fistula healing, or “success” of the intervention. Definitions of these outcomes varied (see Tables 2 and 3); however, many authors defined healing as closure of the opening, healing of the wound, and absence of purulent discharge. Primary healing rates, or the healing rate after the initial intervention of interest without follow-up intervention, in the three studies of MAF reporting this outcome ranged from 65.0% at 1 year in a mix of 31 surgery-experienced and surgery-naïve patients to 86.9% after 6 months in 61 surgery-experienced patients [11, 20, 23]. In another study of 121 patients with a median duration of 74 months (range 8–148 months), patients underwent up to two additional MAFs, until a 100% healing rate was reached [22].

One study reported that 100% of 173 patients healed after fistulectomy, and most patients (168/173) healed within 3–4 weeks. Healing rates were reported for FIPS in one study [21], where 93.2% of 103 patients healed after a mean follow-up of 55.9 months. The authors of these two studies did not report whether the patients were surgically naïve or experienced. One study that assessed healing after modified Parks’ technique reported initial healing in 93.8% of 32 surgery-naïve or surgery-experienced patients with subsequent healing at 100% after a median of 12 months (range 4–24 months) [13].

For LIFT/BioLIFT procedures, primary healing occurred in a range of 57.1% after a median of 12 weeks in a mix of 28 surgery-experienced or surgery-naïve patients to 88% after a mean of 14.6 months (standard error 1.7 months) in a mix of 75 surgery-experienced or surgery-naïve patients [15, 19, 24,25,26]. Healing after initial TROPIS surgery was reached in 84.6% of 61 patients after a median of 9 months (range 6–21 months) in one available study. Including patients who underwent a second TROPIS procedure, the overall healing rate increased to 90.4% [16]. The authors did not report whether these patients were surgery-experienced or surgery-naïve.

Fistula Recurrence/Failure (Surgical Failure)

Seventeen papers reported on fistula recurrence or treatment failure and demonstrated a wide range of findings. The authors defined these outcomes in various ways (see Tables 2 and 3); some authors equated intervention “failure” with “recurrence,” and some reported results separately for these outcomes. Many authors defined recurrence as the clinical occurrence of the fistula, an abscess, or purulent discharge after recovery of the surgical wound within various time periods. In studies of the MAF procedure, recurrence occurred in 4.9–44.4% of patients [11, 12, 18, 20, 22, 23]. Boenicke et al. reported recurrence in three surgery-experienced patients (3/61, 4.9%), one each taking place at 9, 13, and 15 months [11]. Emile et al. reported recurrence in a mix of four surgery-experienced or surgery-naïve patients (4/9, 44.4%) within 1 year of their procedure [18]. Three studies [11, 18, 23] also reported separate failure or disruption of flap rates that ranged from 16% (5/31; three of which occurred within the first week) to 55.5% (5/9 within 1 year of the procedure) of patients [18].

Recurrence rates after fistulectomy ranged from 8.1% (at 1-year follow-up among 175 patients whose surgery experience was not reported) to 60.7% (after a median follow-up period of 26 months [range 2–118 months] among 28 surgery-experienced or surgery-naïve patients) [12, 14, 28]. One study of the modified Parks’ technique reported recurrence after a median of 12 months (range 4–24 months) follow-up in 6.3% of 32 surgery-experienced or surgery-naïve patients who had horseshoe fistula with supralevator extension [13]. The single study of FIPS did not report recurrence rates for patients with CCF [21].

Among studies reporting intersphincteric ligation procedures, recurrence occurred in a range of 7.5% (3 of 40 surgery-experienced and surgery-naïve patients after a mean of 14.2 months follow-up) [17] to 42.9% (12 of 29 surgery-experienced or surgery-naïve patients relapsed within 12 weeks) [15] of patients receiving LIFT/BioLIFT [15, 17, 24, 25, 27]. Treatment failure was experienced in 2.8% (2 of 71 surgery-experienced or surgery-naïve patients after 12 months) [25] to 16.1% (10 of 62 surgery-naïve patients after a median of 24.5 months; range 12–51 months) [26] of patients [19, 25, 26]. The single study of TROPIS did not report recurrence or failure rates [16].

Fecal Incontinence

Tables 2 and 3 indicate the scales and definitions of FI used in each paper. Two of the four studies reporting on FI following MAF procedures did so using the Wexner score, which ranges from 0 (perfect functionality) to 20 (complete incontinence) [29]. Boenicke et al. reported Wexner scores of 0.46 ± 0.97 points at patients’ 6-month follow-up [11]. Lee et al. reported a Wexner score of 0 in 77.8% of patients, 14.8% had a score of 1–5, and 7.4% had a score of 11–13 [20]. Podetta et al. reported FI using the Miller scoring system with range 0–18, with higher numbers representing more frequent incontinence-related symptoms [22, 30]. Of 32 patients who received a second mucosal flap, two patients reported incontinence symptoms. Of patients who received two additional MAF procedures, one patient reported rare gas incontinence after the first MAF and no change in incontinence scores with the subsequent procedures.

One study reported Wexner-identified incontinence in 18.4% of patients with CCF following the FIPS procedure [21]. In El-Said et al., postoperative new-onset minor FI (according to the Wexner score) was reported in 3% of patients following modified Parks’ technique. None of the studies of fistulectomy reported FI by surgery type and for patients with CCF [13].

Seven of eight studies of intersphincteric ligation procedures reported on the outcome of FI. In studies of LIFT and BioLIFT, five studies used Wexner scoring and three used patient-reported scales, including the Fecal Incontinence Quality of Life (FIQL) and the Fecal Incontinence Severity Index (FISI). FI was reported in 0% of patients in two studies [15, 26] using Wexner scoring, and in one study using a self-reported scale [19] (scale name not reported). Ye et al. reported no incontinence in patients postoperatively by Wexner score and FISI [27]. Schulze et al. reported increased incontinence in 1.3% of patients following LIFT [24]. Sun et al. reported improvement in Wexner scores for flatus incontinence after LIFT in 5.7% of patients, and significant improvements in lifestyle, coping, and depression domains of the FIQL [25].

In the one study that reported on TROPIS [16], the authors used the Vaizey incontinence score with a range of 0 (perfect continence) to 24 (complete incontinence) and reported mean scores of less than 1 with no significant change in scores pre- and postoperatively.

Pain

Few studies reported pain as a clinical outcome. The majority used a mix of clinician-reported and patient-reported scales and measured postoperative pain versus perianal pain specifically. One of the two studies of MAF procedures reported that 8.1% (5/61) of patients had experienced postoperative pain that was self-limiting and responsive to analgesics 30 days post-procedure [11]. The scale used in this study was not reported. The second study of MAF used the Numeric Rating Scale (NRS) (1 = no pain; 10 = worst pain imaginable). The mean score did not increase significantly postoperatively (mean score preoperatively 1.4 ± 0.6 vs 3 months postoperatively 1.2 ± 0.5) [23]. One study [21] reported on pain following FIPS and noted that no patients developed postoperative intractable pain after a mean of 55.9 months (range 12–143 months). Using the Short Form-36 Health Survey, version 2, where each item is scored on a range of 0–100 and higher scores indicate more favorable health states, El-Said et al. reported a preoperative mean pain score of 37.5 ± 9.3 and 6-month postoperative mean score of 65.1 ± 7.2 following modified Parks’ technique [13].

Only one study reported on perianal pain associated with intersphincteric ligation procedures. Perianal pain was experienced in 3% of patients following LIFT [24].

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