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

NCT ID: NCT06484660

Last Updated: 2025-09-03

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

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-01

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Fistula Perianal

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Minimally Invasive Approach In The Mucosal Advancement Flap Technique

Group Type EXPERIMENTAL

Minimally Invasive Approach In The Mucosal Advancement Flap Technique

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundació d'investigació Sanitària de les Illes Balears

OTHER_GOV

Sponsor Role collaborator

Hospital Son Llatzer

OTHER

Sponsor Role lead

Responsible Party

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Ignacio Fernandez Hurtado

Specialist in General Surgery. Specialist in Digestive Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital Son Llatzer

Palma de Mallorca, Balearic Islands, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Ignacio Fernández_Hurtado

Role: CONTACT

+34871202000 ext. 2134

Facility Contacts

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IGNACIO FERNANDEZ HURTADO

Role: primary

Other Identifiers

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IB4521/21

Identifier Type: -

Identifier Source: org_study_id

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