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

Not Applicable

Recruiting

• Conditions: Fistula Perianal
• Interventions: Procedure: Minimally Invasive Approach In The Mucosal Advancement Flap Technique

• Registration Number: NCT06484660
• Lead Sponsor: Hospital Son Llatzer

Brief Summary

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

Not available

Study Timeline

• Study Start: 2021-08-01
• Study First Submitted: 2024-06-26
• Status Verified: 2024-07
• Study First Submitted QC: 2024-07-01
• Last Update Submitted: 2024-07-02
• Study First Posted: 2024-07-03
• Last Update Posted: 2024-07-05
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Minimally Invasive Approach In The Mucosal Advancement Flap Technique	Minimally Invasive Approach In The Mucosal Advancement Flap Technique	-

Primary Outcome Measures

Name	Time	Method
Healing rate	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hospital Son Llatzer; 🇪🇸 Palma De Mallorca, Illes Balears, Spain