Efficacy Of Minimally Invasive Approach In The Surgical Treatment Of Complex Perianal Fistula

Condition(s) studied

Investigational drug(s) / intervention(s)

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

Study 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.

Eligibility

Primary outcome measure(s)

• 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.

Trial sites (1)

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