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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-01

Study Completion Date

2023-07-01

Brief Summary

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

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Detailed Description

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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.

Conditions

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Perianal Fistula Transsphincteric Anal Fistula

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Fistulotomy with marsupialization

40 patients with a simple low transsphincteric anal fistula. A fistulotomy with marsupialization is performed.

Group Type ACTIVE_COMPARATOR

Fistulotomy with marsupialization

Intervention Type PROCEDURE

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.

Fistulotomy with open wound

40 patients with a simple low transsphincteric anal fistula. A fistulotomy leaving the wound open is performed.

Group Type ACTIVE_COMPARATOR

Fistulotomy with open wound

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes