Efficacy Of Minimally Invasive Approach In The Surgical Treatment Of Complex Perianal Fistula
NCT ID: NCT06484660
Last Updated: 2025-09-03
Study Results
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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RECRUITING
NA
40 participants
INTERVENTIONAL
2021-08-01
2025-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Minimally Invasive Approach In The Mucosal Advancement Flap Technique
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
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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Fundació d'investigació Sanitària de les Illes Balears
OTHER_GOV
Hospital Son Llatzer
OTHER
Responsible Party
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Ignacio Fernandez Hurtado
Specialist in General Surgery. Specialist in Digestive Surgery
Locations
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Hospital Son Llatzer
Palma de Mallorca, Balearic Islands, Spain
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IB4521/21
Identifier Type: -
Identifier Source: org_study_id
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