Efficacy Of Minimally Invasive Approach In The Surgical Treatment Of Complex Perianal Fistula
ConditionFistula Perianal
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHospital Son Llatzer
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
Non-cryptoglandular internal fistulous orifice (IFO).
Extrasphincteric fistula.
Coexistence of anal fissure.
Coexistence of hemorrhoids tributary to surgery.
Trial design
Treatments tested in this trial
- Minimally Invasive Approach In The Mucosal Advancement Flap Technique
Treatment groups
40 Participants
are divided into 1 treatment groupSponsors and collaborators
Hospital Son Llatzer
Lead sponsor
Fundació d'investigació Sanitària de les Illes Balears
Collaborator
Source ClinicalTrials.gov