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

Recruiting now · Not applicable

Conditions studied: Fistula Perianal

In brief

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.

Key facts

Study ID

NCT06484660

Run by

Hospital Son Llatzer

People needed

40

Starts

2021-08-01

Expected to finish

2026-12-31

Last updated by the study team

2026-07-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Hospital Son Llatzer — Palma de Mallorca, Balearic Islands, Spain (enrolling)

Full record on ClinicalTrials.gov

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