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| Name | Class |
|---|---|
| Fundació d'investigació Sanità ria de les Illes Balears | OTHER_GOV |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Minimally Invasive Approach In The Mucosal Advancement Flap Technique | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Minimally Invasive Approach In The Mucosal Advancement Flap Technique | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Healing rate | 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. | six months |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pain | Pain measured in visual analogic scale (VAS). Scale: 0 to 10. Higher scores mean a worse outcome. | one week |
| Global morbidity | Clavien Dindo Scale. Scale: 1 to 5. Higher scores mean worse complications. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ignacio Fernández_Hurtado | Contact | +34871202000 | 2134 | ifernandez@hsll.es |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Son Llatzer | Recruiting | Palma de Mallorca | Balearic Islands | 07198 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42151466 | Derived | Fernandez-Hurtado I, Pages-Valle N, Castro-Suarez M, Sarubbo MF, Baena-Bradaschia S, Cifuentes-Rodenas JA, Serra-Aracil X. Microsurgery in mucosal advancement flap repair: a microscope-assisted, tissue-sparing approach for managing complex perianal fistulas within the IDEAL Stage 1 framework. Surg Endosc. 2026 Jun;40(6):5387-5396. doi: 10.1007/s00464-026-12876-5. Epub 2026 May 18. |
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| one month |
| Quality of life score | SF 36 questionnaire. 36 items. Higher scores mean a better quality of life. | six months |
| Fecal incontinence | Measured in Wexner scale. Score 0 to 20. Higher scores mean a worse outcome. | six months |