Prospective study to predict outcome following anal fistula surgery
Research type
Research Study
Full title
Prospective study to predict functional outcome following anal fistula lay open through preoperative assessment using combined anal ultrasound and vector volume manometry.
IRAS ID
229773
Contact name
Andrew Williams
Contact email
Sponsor organisation
Guy’s and St Thomas’ NHS Foundation Trust R&D Department
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
Fistula-in-ano is one of the most common anorectal diseases with an incidence of 8.6-10 per 100000/year. A fistula is a tunnel from the inside of the anus, through the sphincter muscles onto the external perianal skin. It affects young healthy adults, with a male preponderance.
The most reliable treatment to cure the fistula track is to lay the tunnel open fully to allow complete healing, although this comes at the cost of division of the portion of sphincter muscles contained within the track. For low fistula, laying open is the treatment of choice, due to high success rate and low recurrence rate. For high and complex fistula, the significant muscle division involved in lay open, results in a reduction in continence.
At present the decision of which fistulas are suitable for lay open is not based on any robust pre-operative assessment but relies only on clinical assessment and surgeon experience.
The aim of the study is to create a Clinical Diagnostic algorithm to predict quality of life and sphincter function before surgical treatment using endoanal ultrasound and anorectal manometry. These studies are routinely performed before operation for fistula in ano in our Department. In addition the results of preoperative endoanal ultrasound and anorectal manometry will be correlated with Continence score and Quality of life obtained through validated questionnaires administered to all patients before doing endoanal ultrasound and anorectal manometry.
We will administer again the Continence score and Quality of life questionnaires 3 months after surgical treatment and during the same appointment we will repeat the endoanal ultrasound and anorectal manometry. Then we will correlate post-operative and pre-operative results to assess changes in anal sphincter anatomy and function.
The end-point is to validate the pre-assessment of anal fistula through these two tests in order to obtain more robust information before surgical treatment.
REC name
London - London Bridge Research Ethics Committee
REC reference
18/LO/0062
Date of REC Opinion
16 Mar 2018
REC opinion
Further Information Favourable Opinion