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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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Minimally Invasive Approach In The Mucosal Advancement Flap Technique

    Procedure/Surgery

    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

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Minimally Invasive Approach In The Mucosal Advancement Flap TechniqueExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
six months

Secondary outcomes

1

Postoperative pain

Pain measured in visual analogic scale (VAS). Scale: 0 to 10. Higher scores mean a worse outcome.

Time frame
one week
2

Global morbidity

Clavien Dindo Scale. Scale: 1 to 5. Higher scores mean worse complications.

Time frame
one month
3

Quality of life score

SF 36 questionnaire. 36 items. Higher scores mean a better quality of life.

Time frame
six months
4

Fecal incontinence

Measured in Wexner scale. Score 0 to 20. Higher scores mean a worse outcome.

Time frame
six months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hospital Son Llatzer

Lead sponsor

Fundació d'investigació Sanitària de les Illes Balears

Collaborator

Source ClinicalTrials.gov
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