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Impact of Preoperative Bowel Preparation on Healing Outcomes in FiLaC

NCT07800065 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2026-09-02

No results posted yet for this study

Summary

Background: Fistula tract laser closure (FiLaC) has emerged as a sphincter-preserving treatment for anal fistula (AF). However, the optimal role of preoperative bowel preparation (BP) in enhancing postoperative outcomes remains contentious. While some surgeons recommend enemas to empty the rectum, others ignore BP altogether due to concerns about possible contamination from enemas. Current guidelines suggest that the decision to perform BP is at the surgeon's discretion, as it is not definitively linked to healing rates.

Objective: This prospective, non-randomized observational cohort study aims to evaluate whether preoperative bowel preparation significantly impacts primary healing rates following FiLaC in patients with anal fistula.

Methods: One hundred consecutive patients undergoing FiLaC will be prospectively enrolled and stratified into two cohorts: Group A (BP) and Group B (no BP). Anal fistulas will be classified by Parks classification. The primary outcome is complete clinical healing at three months, defined by the absence of discharge, an epithelialized external opening, and no recurrence. Secondary outcomes include six-month healing rates, recurrence, postoperative pain, quality of life, Wexner continence scores, and complication rates. Multivariate logistic regression will be employed to control for potential confounders, including smoking status, prior seton use, and fistula complexity.

Discussion: This study aims to fill the evidence gap regarding the benefits of preoperative BP in FiLaC procedures, improving perioperative protocols to optimize healing outcomes while reducing unnecessary interventions. The findings will provide clinicians with evidence-based guidance on BP strategies.

Conditions

  • Anal Fistula
  • Fistula in Ano
  • Laser
  • Anal Fistula Surgery
  • Bowel Preparation

Interventions

PROCEDURE

Bowel preparation before fistula laser closure (FiLaC) surgery

Standardized bowel preparation will be administered to Group A patients. This involves a clear liquid diet the day prior to surgery. Polyethylene glycol (3 liters) will be initiated at 16:00 PM on the evening before the operation, consumed as 250 mL every 10 minutes, aiming for completion by 21:00 PM. Clear liquid intake is permitted until midnight. If there are particles in the stool on the morning of the operation, a rectal enema will be administered.

Sponsors & Collaborators

  • Acibadem Kent Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-01
Primary Completion
2027-04-01
Completion
2027-12-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07800065 on ClinicalTrials.gov