A systematic review of the quality of reporting of interventions in the surgical treatment of Crohn’s anal fistula: an assessment using the TIDiER and Blencowe frameworks

Background Crohn’s anal fistula is a challenging condition, and may require multiple surgical procedures. To replicate successful procedures, these must be adequately reported in the literature. The aim of this study was to review the quality of reporting of components of surgical interventions for Crohn’s anal fistula. Methods A systematic review was conducted. It was registered with PROSPERO (CRD:42019135157). The Medline and EMBASE databases were searched for studies reporting interventions intended to close fistula in patients with Crohn’s disease, published between 1999 and August 2019. Abstracts and full texts were screened for inclusion by two reviewers. Dual extraction of data was performed to compare reporting to the TIDiER and Blencowe frameworks for reporting of interventions. Results Initial searches identified 207 unique studies; 38 full texts were screened for inclusion and 33 were included. The most common study design was retrospective cohort (17/33), and the most frequently reported interventions were anal fistula plug (n = 8) and fibrin glue (n = 6). No studies showed coverage of all domains of TIDieR. Reporting was poor among domains related to who provided an intervention, where it was provided, and how it was tailored. Reporting of domains in the Blencowe framework was poor; the majority of studies did not report the component steps of procedures or efforts to standardise them. Conclusions This study demonstrates that reporting on technical aspects of interventions for Crohn’s anal fistula is poor. Surgeons should aim to improve reporting to allow accurate reproduction of techniques both in clinical practice and in clinical trials.

Treatment of Complex Anal Fistula by Video-Assisted Anal Fistula Treatment Combined with Anal Fistula Plug: A Single-Center Study

Objective. The surgical treatment of complex anal fistulae is very challenging because of the incidence of incontinence after traditional approaches. There are no studies on the role of video-assisted anal fistula treatment (VAAFT) combined with anal fistula plug (AFP) in the complex anal fistulae. The aim of this study was to demonstrate the efficacy of treating complex anal fistulae using VAAFT combined with AFP. Method. This was a retrospective, nonrandomized observational study. 57 consecutive patients with complex anal fistulae who had undergone the VAAFT with AFP in our hospital between April 2016 and December 2019 were included. The primary outcomes were the cure rate, recurrence rate, and Wexner incontinence scores; the secondary outcomes were surgery time, blood loss, wound healing time postoperatively, pain, and patient satisfaction. Results. All 57 patients completed the surgery and follow-up, with an average follow-up time of 28 months; 6 patients suffered with recurrence (recurrence rate: 10.5%). The average surgery time was 57.9 minutes, and the average wound healing time was 46 days. There were no severe postoperative complications, and anal sphincter function was protected in all patients. Conclusions. The treatment of complex anal fistula by VAAFT combined with AFP is safe and effective, has a high healing rate and few postoperative complications, and is a promising surgery that can effectively protect the patient’s anal sphincter function.

Video-assisted anal fistula treatment combined with anal fistula plug for treatment of horseshoe anal fistula

Objective Horseshoe anal fistula is a common anorectal disease, and there is no standard procedure for its treatment. In this study, we performed a modified surgical procedure for the treatment of horseshoe anal fistula and investigated its efficacy and adverse effects. Methods We retrospectively analyzed the outcomes of video-assisted anal fistula treatment combined with an anal fistula plug (VAAFT-Plug) in 26 patients with a horseshoe anal fistula. The follow-up period ranged from 6 to 18 months. Preoperative and postoperative data were collected to analyze the cure rate, anal sphincter function, and incidence of complications. Results The surgeries were successfully performed in all patients, 23 of whom were cured (effective cure rate of 88.46%). Three patients developed recurrence and were cured after traditional surgery. No patients developed severe complications or postoperative anal incontinence. The VAAFT-Plug protocol was performed with a small incision in the fistula that subsequently promoted fistula healing and preserved sphincter function. Conclusion Although randomized controlled trials will be needed to fully validate these findings, our results suggest that VAAFT-Plug represents a promising treatment strategy for horseshoe anal fistulas. This technique preserves normal anal function and achieves satisfactory outcomes in most patients.

Manejo de la fístula anorrectal compleja. LIFT, colgajo de avance y otras técnicas.

Las fístulas anorrectales complejas son un desafío para el coloproctólogo. Son una patología frecuente que afecta la calidad de vida de los pacientes. La patogénesis aún no esta clara, estarían involucradas citoquinas y el proceso de transición de epitelio a mesénquima. El gold estandar para su estudio es la resonancia nuclear magnética, su uso por si mismo disminuye la recurrencia. El objetivo del tratamiento es lograr la curación sin afectar la función del esfínter evitando las recidivas. Existen múltiples técnicas, siendo la de mayor aceptación la ligadura interesfinteriana del trayecto fistuloso, con tasa de curación sobre el 70%, con mínimo impacto en continencia. Esta revisión incluye otras técnicas como el colgajo endorrectal de avance, uso de sellante, Permacol, células madres, Anal fistula plug, Video asisted anal fistula treatment, Over the scope clip y Fístula laser closure.

Anal fistula plug versus surgeon’s preference for surgery for trans-sphincteric anal fistula: the FIAT RCT

Background The aim of fistula surgery is to eradicate the disease while preserving anal sphincter function. The efficacy of the Surgisis® anal fistula plug (Cook Medical, Bloomington, IN, USA) in the treatment of trans-sphincteric fistula-in-ano has been variably reported. Objectives To undertake a randomised comparison of the safety and efficacy of the Surgisis anal fistula plug in comparison with surgeon’s preference for the treatment of trans-sphincteric anal fistulas. Design A randomised, unblinded, parallel-arm, prospective, multicentre clinical trial. Setting Hospitals in the UK NHS involving colorectal surgeons accredited by the Association of Coloproctology of Great Britain and Ireland. Participants Adult patients suffering from trans-sphincteric fistula-in-ano of cryptoglandular origin. Interventions Patients were randomised on a 1 : 1 basis to either the fistula plug or the surgeon’s preference [e.g. fistulotomy, cutting seton, advancement flap or ligation of intersphincteric fistula tract (LIFT) procedure]. Main outcome measures The primary outcome measure was quality of life as measured by the Faecal Incontinence Quality of Life (FIQoL) questionnaire at 12-month follow-up. Secondary outcome measures included clinical and radiological fistula healing rates, faecal incontinence rates, complications rates, reintervention rates and cost-effectiveness. Results Between May 2011 and March 2016, 304 participants were recruited (152 fistula plug vs. 152 surgeon’s preference). No difference in FIQoL score between the two trial groups was seen at the 6-week, 6-month or 12-month follow-up. Clinical evidence of fistula healing was reported in 66 of 122 (54%) participants in the fistula plug group and in 66 of 119 (55%) participants in the surgeon’s preference group at 12 months. Magnetic resonance imaging (MRI) showed fistula healing in 54 of 110 (49%) participants in the fistula plug group and in 63 of 112 (56%) participants in the surgeon’s preference group. Variation in 12-month clinical healing rates was observed: 55%, 64%, 75%, 53% and 42% for fistula plug, cutting seton, fistulotomy, advancement flap and LIFT procedure, respectively. Faecal incontinence rates were low at baseline, with small improvement in both groups post treatment. Complications and reinterventions were frequent. The mean total costs were £2738 [standard deviation (SD) £1151] in the fistula plug group and £2308 (SD £1228) in the surgeon’s preference group. The average total quality-adjusted life-years (QALYs) gain was much smaller in the fistula plug group (0.829, SD 0.174) than in the surgeon’s preference group (0.790, SD 0.212). Using multiple imputation and probabilistic sensitivity analysis, and adjusting for differences in baseline EuroQol-5 Dimensions, three-level version utility, there was a 35–45% chance that the fistula plug was as cost-effective as surgeon’s preference over a range of thresholds of willingness to pay for a single QALY of £20,000–30,000. Limitations Limitations include a smaller sample size than originally calculated, a lack of blinding that perhaps biased patient-reported outcomes and a lower compliance rate with MRI at 12-month follow-up. Conclusions The Surgisis anal fistula plug is associated with similar FIQoL score to surgeon’s preference at 12-month follow-up. The higher costs and highly uncertain and small gains in QALYs associated with the fistula plug mean that this technology is unlikely to be considered a cost-effective use of resources in the UK NHS. Future work Further in-depth analysis should consider the clinical and MRI characteristics of fistula-in-ano in an attempt to identify predictors of fistula response to treatment. Trial registration Current Controlled Trials ISRCTN78352529. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 21. See the NIHR Journals Library website for further project information.