Treatment of Lower Transsphincteric Perianal Fistula: Fistulotomy With Marsupialization vs Open Wound

Not Applicable

Withdrawn

• Conditions: Perianal Fistula; Transsphincteric Anal Fistula
• Interventions: Procedure: Fistulotomy with open wound; Procedure: Fistulotomy with marsupialization

• Registration Number: NCT04722965
• Lead Sponsor: Consorci Sanitari de l'Alt Penedès i Garraf

Brief Summary

This study will compare the results of marsupialization versus open wound after fistulotomy in low transsphincteric perianal fistulas.

Detailed Description

This is a multi-center triple blinded randomized clinical trial in which we'll compare two techniques for the treatment of simple low transsphincteric perianal fistulas. 40 patients will undergo a fistulotomy with marsupialization and 40 patients will undergo a fistulotomy with open wound. There will be an inclussion visit in which personal information will be recorded and the consent will be signed. Randomization will be done after inclusion, following a balanced blocks model. Information of the surgery technic won't be available for the investigator. The patients will have a journal in which they'll write their postoperative symptoms. Follow up will be done at weeks 2, 4 and 6 by the main investigator of each center. Data will be based in clinical examination, patient's diary and medical records. Statistical analysis of the primary outcome will be based in a superiority analysis using the Mantel-Cox test, or in case needed, a multivariate Cox regression analysis. The secondary outcomes will be analyzed by comparing times, percentages, mean or median with parametric or non parametric tests as it corresponds.

Study Timeline

• Study First Submitted: 2021-01-21
• Study First Submitted QC: 2021-01-21
• Study First Posted: 2021-01-25
• Study Start: 2021-04-01
• Primary Completion: 2023-02-01
• Study Completion: 2023-07-01
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-18
• Last Update Posted: 2024-03-19

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Low transsphinteric perianal fistula, defined as a single tract in the lower third of the anal sphincter, confirmed by ultrasound and intraoperative evaluation.
• Ability to understand the study, to sign the consent and to complete the follow-up.

Exclusion Criteria

• Under 18 years of age.
• Complex/recurrent fistula.
• Patients in which by clinical criteria is decided not to perform a fistulotomy.
• Anorectal malignancy.
• Crohn's desease.
• ASA IV or other contraindication for surgery.
• Inmunosuppressed patients or in treatment with steroids or cytotoxic drugs.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fistulotomy with open wound	Fistulotomy with open wound	40 patients with a simple low transsphincteric anal fistula. A fistulotomy leaving the wound open is performed.
Fistulotomy with marsupialization	Fistulotomy with marsupialization	40 patients with a simple low transsphincteric anal fistula. A fistulotomy with marsupialization is performed.

Primary Outcome Measures

Name	Time	Method
Wound healing time	6 weeks	Comparisson of the time it takes for the wound to not have areas without epithelium after the fistulotomy between the group with marsupialization and the open wound group.

Secondary Outcome Measures

Name	Time	Method
Hospitalization time	2 days	Days the patient has to stay admitted in the hospital.
Return to daily activities	6 weeks	Days it takes the patients to return their daily activities (e.g. job).
Operating time	60 minutes	Time the surgery takes since the assessment of the fistula tract to the beginning of dressing of the postoperative wound. It's measured in minutes.
Who performs the dressing change	6 weeks	Indicate who performs the dressing change: Patient, family member or medical professional.
Postoperative pain	6 weeks	Maximum pain experienced by the patient in the postoperative period measured by the visual scale of pain.
Bleeding of the postoperative wound	6 weeks	Number of bleeding episodes that require more changing of the dressings or assistance of a medical professional.
Anal incontinence	6 weeks	Postoperative anal incontinence measured by the Browning and Parks incontinence scale: I: normal continence, II: Continent for solid and liquid stools but not for flatus, III: Continent for solid stools only, IV: Complete incontinence.
Frequency of dressing change	6 weeks	Number of times per day a patient needs a dressing change
Postoperative wound infection	6 weeks	Presence of erythema, induration surrounding the wound or suppuration with or without an isolated pathogenic microorganism.
Recurrence of the fistula	1 year	Reappearance of the fistula after complete healing of the surgical wound within the period of the study.

Trial Locations

Locations (1)

Consorci Sanitari Alt Penedes i Garraf; 🇪🇸 Sant Pere De Ribes, Barcelona, Spain