Fistula Perianal
Conditions
Keywords
Perianal Fistula, Mucosal Advancement Flap, Minimally Invasive Approach
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.
Interventions
PROCEDUREMinimally 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
Sponsors
Hospital Son Llatzer
Fundació d'investigació Sanitària de les Illes Balears
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain | one week | Pain measured in visual analogic scale (VAS). Scale: 0 to 10. Higher scores mean a worse outcome. |
| Global morbidity | one month | Clavien Dindo Scale. Scale: 1 to 5. Higher scores mean worse complications. |
| Quality of life score | six months | SF 36 questionnaire. 36 items. Higher scores mean a better quality of life. |
| Fecal incontinence | six months | Measured in Wexner scale. Score 0 to 20. Higher scores mean a worse outcome. |
Countries
Spain
Contacts
CONTACTIgnacio Fernández_Hurtado
Outcome results
None listed