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

Randomized Clinical Trial for the Treatment of Lower Transsphincteric Perianal Fistula Using Fistulotomy With Marsupialization vs Open Wound

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

Study Overview

• Status: Withdrawn
• Conditions: Perianal Fistula; Transsphincteric Anal Fistula
• Intervention / Treatment: Procedure: Fistulotomy with marsupialization; Procedure: Fistulotomy with open wound

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Sant Pere De Ribes, Barcelona, Spain, 08810
      • Consorci Sanitari Alt Penedes i Garraf

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Fistulotomy with marsupialization; 40 patients with a simple low transsphincteric anal fistula. A fistulotomy with marsupialization is performed.	Procedure: Fistulotomy with marsupialization; A probe is placed in the fistula tract and it's laid open over that probe. The tract is curretted. Wound edges are sutured to the bottom of the fistula using interrupted sutures of vicryl 3-0 completing the marsupialization.
Active Comparator: Fistulotomy with open wound; 40 patients with a simple low transsphincteric anal fistula. A fistulotomy leaving the wound open is performed.	Procedure: Fistulotomy with open wound; A probe is placed in the fistula tract and it's laid open over that probe. The tract is curretted. The wound is left open.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound healing time	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.	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain	Maximum pain experienced by the patient in the postoperative period measured by the visual scale of pain.	6 weeks
Return to daily activities	Days it takes the patients to return their daily activities (e.g. job).	6 weeks
Operating time	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.	60 minutes
Hospitalization time	Days the patient has to stay admitted in the hospital.	2 days
Anal incontinence	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.	6 weeks
Frequency of dressing change	Number of times per day a patient needs a dressing change	6 weeks
Who performs the dressing change	Indicate who performs the dressing change: Patient, family member or medical professional.	6 weeks
Postoperative wound infection	Presence of erythema, induration surrounding the wound or suppuration with or without an isolated pathogenic microorganism.	6 weeks
Recurrence of the fistula	Reappearance of the fistula after complete healing of the surgical wound within the period of the study.	1 year
Bleeding of the postoperative wound	Number of bleeding episodes that require more changing of the dressings or assistance of a medical professional.	6 weeks

Collaborators and Investigators

• Sponsor: Consorci Sanitari de l'Alt Penedès i Garraf
• Investigators: Principal Investigator: Jessica Gonzales, MD, CSAPG

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Estimated): February 1, 2023
• Study Completion (Estimated): July 1, 2023

Study Registration Dates

• First Submitted: January 21, 2021
• First Submitted That Met QC Criteria: January 21, 2021
• First Posted (Actual): January 25, 2021

Study Record Updates

• Last Update Posted (Actual): March 19, 2024
• Last Update Submitted That Met QC Criteria: March 18, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: perianal fistula; marsupialization; low transsphincteric anal fistula; fistulotomy
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Rectal Diseases; Intestinal Fistula; Digestive System Fistula; Fistula; Rectal Fistula
• Other Study ID Numbers: CSAPG-13

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No