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

Last updated: March 18, 2024
Sponsor: Consorci Sanitari de l'Alt Penedès i Garraf
Overall Status: Trial Not Available

Phase

N/A

Condition

Rectal Disorders

Acne Inversa

Treatment

Fistulotomy with marsupialization

Fistulotomy with open wound

Clinical Study ID

NCT04722965
CSAPG-13
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

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

Treatment Group(s): 2
Primary Treatment: Fistulotomy with marsupialization
Phase:
Study Start date:
April 01, 2021
Estimated Completion Date:
July 01, 2023

Study 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.

Connect with a study center

  • Consorci Sanitari Alt Penedes i Garraf

    Sant Pere De Ribes, Barcelona 08810
    Spain

    Site Not Available

  • Consorci Sanitari Garraf

    Sant Pere De Ribes, Barcelona 08810
    Spain

    Active - Recruiting

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