Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06484660

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

Led by Hospital Son Llatzer · Updated on 2025-09-03

40

Participants Needed

1

Research Sites

230 weeks

Total Duration

On this page

Sponsors

H

Hospital Son Llatzer

Lead Sponsor

F

Fundació d'investigació Sanitària de les Illes Balears

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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.
Not Eligible

You will not qualify if you...

  • 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.

AI-Screening

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Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Hospital Son Llatzer

Palma de Mallorca, Balearic Islands, Spain, 07198

Actively Recruiting

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Research Team

I

Ignacio Fernández_Hurtado

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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