Minimally invasive surgery for complex perianal fistula treatment
Efficacy Of Minimally Invasive Approach In The Mucosal Advancement Flap Technique For The Surgical Treatment Of Previously Untreated Complex Perianal Fistula
This study is testing a new, less invasive surgery for treating complex perianal fistulas to see if it helps patients heal better and feel less pain compared to traditional surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospital Son Llatzer Academic / other |
| Locations | 1 site (Palma de Mallorca, Balearic Islands) |
| Trial ID | NCT06484660 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of a minimally invasive surgical technique, specifically the mucosal advancement flap, in treating complex perianal fistulas. The study aims to compare healing rates, postoperative pain, fecal incontinence, and healing time between patients undergoing this minimally invasive approach and those receiving traditional non-minimally invasive surgery. Participants will be monitored through follow-up visits and symptom assessments over six months to evaluate their recovery and quality of life.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with a complex perianal fistula that has not been previously treated surgically.
Not a fit: Patients with certain conditions such as inflammatory bowel disease, anal or colorectal cancer, or other complicating factors may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved healing rates and reduced postoperative complications for patients with complex perianal fistulas.
How similar studies have performed: Other studies have shown promising results with minimally invasive techniques in surgical treatments, suggesting potential for success in this approach as well.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Palma de Mallorca, Balearic Islands
- Hospital Son Llatzer — Palma de Mallorca, Balearic Islands, Spain (Recruiting)
Study contacts
- Study coordinator: Ignacio Fernández_Hurtado
- Email: ifernandez@hsll.es
- Phone: +34871202000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.