Efficacy of cyanoacrylate glue versus fistulotomy in the management of simple low anal fistula in tertiary care hospital - A Randomised Controlled study

SUMMARY OF PROTOCOL

Objective: To compare the duration of wound healing between cyanoacrylate glue application and fistulotomy in patients with simple low anal fistula. The secondary outcome measured are Post operative pain, Duration of hospital stay, Maintenance of anal continence.

Materials and methods:

This Randomized control study design includes patients above 18 years of age with simple low anal fistula. Exclusion criteria are complex and high anal fistula and Diabetes mellitus. After Computer generated block randomization, two groups with 28 study participants in each group will be allocated. Group A will undergo fistulotomy. Group B will receive 1-3 ml of N-butyl cyanoacrylate glue in to the fistula tract. After 24 hours, patient will be discharged and will be followed up every 2 weeks for one month and monthly once for 2 months.

Data will be collected in the predesigned case report form and following measuring tools will be used

1)Complete healing (epithelization) at 24 hours after surgery, at time of discharge,1st,2nd,3rd month

2)Pain will be assessed before intervention and at 24 hours after surgery, at time of discharge,1st, 2nd,3rd month using Visual analog scale

3)Post operative incontinence to Gas/Liquids/solids at 24 hours, after surgery, at time of discharge, 1st, 2nd, 3rd month will be measured using The Wexner score

All the collected data will be entered in a Microsoft Excel sheet and will be analyzed using SPSS software and categorical data will be expressed in percentage or number and will be measured using Chi-square test. All numerical data will be expressed as mean and standard deviation and measured using independence t test. P value <0.05 will be considered as significant.