Efficacy Of Minimally Invasive Approach In The Surgical Treatment Of Complex Perianal Fistula

July 5, 2026 updated by: Ignacio Fernandez Hurtado, Hospital Son Llatzer

Efficacy Of Minimally Invasive Approach In The Mucosal Advancement Flap Technique For The Surgical Treatment Of Previously Untreated Complex Perianal Fistula

The goal of this clinical trial is to study whether the minimally invasive approach in the mucosal advancement flap technique for the treatment of complex perianal fistula improves the healing rate compared to non-minimally invasive surgery.

The main question it aims to answer is:

- Does the healing rate of patients undergoing minimally invasive approach in the mucosal advancement flap technique improve compared to patients undergoing non-minimally invasive surgery?

Researchers will also compare minimally invasive approach in the mucosal advancement flap technique to the non-minimally invasive approach in terms of postoperative pain, fecal incontinence and healing time.

Quality of life and global morbidity will also be analyzed.

Participants will:

  • Undergo surgical treatment of complex perianal fistula performed by mucosal advancement flap performed by a minimally invasive technique.
  • Attend control visits and fill in symptom forms one week, one month, three months and six months after the surgical procedure.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Ignacio Fernández_Hurtado
  • Phone Number: 2134 +34871202000
  • Email: ifernandez@hsll.es

Study Locations

  • Spain
    • Balearic Islands
      • Palma de Mallorca, Balearic Islands, Spain, 07198
        • Recruiting
        • Hospital Son Llatzer
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age older than 18.
  • Present with a complex perianal fistula not surgically treated with curative intention.
  • Present only one main fistulous tract.
  • Mucosal advancement flap as the chosen technique for the treatment of the fistula.
  • Patient has given informed consent to participate in the study.

Exclusion Criteria:

  • Non-cryptoglandular internal fistulous orifice (IFO).
  • Extrasphincteric fistula.
  • Coexistence of anal fissure.
  • Coexistence of hemorrhoids tributary to surgery.
  • Coexistence of anal or rectal prolapse.
  • Coexistence of inflammatory bowel disease.
  • Coexistence of anal or colorrectal cancer.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Minimally Invasive Approach In The Mucosal Advancement Flap Technique
Procedure: Minimally Invasive Approach In The Mucosal Advancement Flap Technique
Surgical treatment of complex perianal fistula. Less tissue damage. Electrocoagulation source with 75% lower power. Better de-epithelialization of the intra-sphinteric tract. More precise closure of orifice. More consistent mucosal flap

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Healing rate
Time Frame: six months
Healing will be measured if 4 criteria are present: no supuration or pain for more than a week, no open external fistulous orifice, no palpable trajectory, no internal fistulous orifice and no tract or collections in 3D endoanal ultrasound.
six months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain
Time Frame: one week
Pain measured in visual analogic scale (VAS). Scale: 0 to 10. Higher scores mean a worse outcome.
one week
Fecal incontinence
Time Frame: six months
Measured in Wexner scale. Score 0 to 20. Higher scores mean a worse outcome.
six months
Global morbidity
Time Frame: one month
Clavien Dindo Scale. Scale: 1 to 5. Higher scores mean worse complications.
one month
Quality of life score
Time Frame: six months
SF 36 questionnaire. 36 items. Higher scores mean a better quality of life.
six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Son Llatzer

Collaborators

Fundació d'investigació Sanitària de les Illes Balears

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2021

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

June 26, 2024

First Submitted That Met QC Criteria

July 1, 2024

First Posted (Actual)

July 3, 2024

Study Record Updates

Last Update Posted (Actual)

July 7, 2026

Last Update Submitted That Met QC Criteria

July 5, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IB4521/21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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