Video-assisted anal fistula treatment versus fistulectomy and sphincter repair in the treatment of high cryptoglandular anal fistula: a randomized clinical study

BACKGROUND: Video-assisted anal fistula treatment (VAAFT) may have a recurrence rate comparable to that of fistulectomy and sphincter repair (FSR) in the treatment of high anal fistula and with potential advantages in wound healing, functional outcome and quality of life. The aim and objectives of the study are to compare the outcome of VAAFT with that of FSR for high cryptoglandular anal fistula. METHODS: This was a single-centre randomized controlled trial of adults with high anal fistula comparing FSR with VAAFT. Primary outcome was fistula recurrence. Secondary outcomes were results of anal manometry, quality of life and faecal continence. A power calculation of 33 patients in each arm (1 : 1) was based on recurrence in the FSR and VAAFT groups of 5 per cent and 30 per cent respectively. Follow-up at 6 months after surgery included physical examination, MRI, anal manometry, quality-of-life assessment (RAND SF 36 questionnaire) and faecal-continence assessment (Wexner score). RESULTS: The study was terminated early due to high recurrence rates in both groups. A total of 45 patients were included. Recurrence rates were 65 per cent for VAAFT and 27 per cent for FSR, with hazard ratio 4.18 (P = 0.016). Length of the fistula was a risk factor with an association with recurrence (hazard ratio 1.8, P = 0.020). There were significant differences in quality of life in favour of FSR and in anal manometry in favour of VAAFT with a significant improvement in Wexner score in both groups. CONCLUSION: FSR was associated with a lower recurrence rate than VAAFT in the management of complex anal fistulae in this single-centre study but the study was terminated early due to higher than predicted recurrence rate in both groups. REGISTRATION NUMBER: NCT02585167 (http://www.clinicaltrials.org).