Impact of Preoperative Bowel Preparation on Healing Outcomes in FiLaC
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAcibadem Kent Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years
Diagnosed cryptoglandular AF (simple or complex)
Scheduled for FiLaC procedure
Provided written informed consent
Disqualifiers
Fistula associated with Crohn's disease, tuberculosis, or malignancy
Signs of inflammation (presence of abscess)
Anovaginal fistulas
History of pelvic radiotherapy
Trial population
Patients with anal fistula
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Bowel preparation before fistula laser closure (FiLaC) surgery
Procedure/SurgeryStandardized 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.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Anal fistula patients receiving bowel preparation before FiLaC1 intervention
Group B: Anal fistula patients receiving no bowel preparation before FiLaC0 interventions
Trial outcomes
Primary outcomes
1
Primary outcome Complete clinical healing
Complete clinical healing is defined as a fully epithelialized external opening with no discharge, inflammation, or other signs of fistula persistence. An independent, blinded colorectal surgeon will assess healing during follow-up. The Perianal Fistula Disease Severity Score (PFDS, 0-4 scale) will also be used for secondary evaluation. Fistulas will be classified as low/simple (superficial, intersphincteric) or high/complex (transsphincteric, suprasphincteric, extrasphincteric) during analysis.
Time frame
Three monthsSecondary outcomes
1
Secondary Outcome Clinical healing at six months
Defined as a fully epithelialized external opening with no discharge, inflammation, or other signs of fistula persistence, assessed by an independent, blinded colorectal surgeon. 2.Defined as return of discharge, non-epithelialized external opening, or other signs of fistula after initial healing. 3.Pain scores measured on a 0-10 scale at four time points: postoperative day 1, week 1, month 1, and month 3. 4\. Wexner
Time frame
Six months2
Clinically confirmed fistula recurrence
Recurrence defined as return of symptoms (e.g., discharge, non-healed external opening) after initial healing, confirmed during clinical examination.
Time frame
Up to 6 months postoperatively3
Postoperative pain measured by Visual Analog Scale (VAS)
Pain will be self-reported by the patient using a 0-10 VAS scale on postoperative day 1, week 1, month 1, and month 3.
Time frame
Day 1, Week 1, Month 1, Month 34
Change in continence status measured by Wexner Continence Score
Wexner score will be recorded preoperatively and at 3 months postoperatively to assess changes in continence function
Time frame
Preoperative and 3 months postoperativeLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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