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NCT Number: NCT06484660

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

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.

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Key information

Conditions

Fistula Perianal

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Son Llatzer

Palma de Mallorca, Balearic Islands, 07198, Spain

Location status: Recruiting

Location contact

IGNACIO FERNANDEZ HURTADO

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Minimally Invasive Approach In The Mucosal Advancement Flap Technique

Procedure

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

Primary outcomes

  1. Healing rate

    Time frame: 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 outcomes

  1. Postoperative pain

    Time frame: one week

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

  2. Global morbidity

    Time frame: one month

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

  3. Quality of life score

    Time frame: six months

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

  4. Fecal incontinence

    Time frame: six months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Ignacio Fernández_Hurtado

CONTACT

[email protected]

+34871202000 ext. 2134

Sponsors and collaborators

Lead sponsor

Hospital Son Llatzer

Other

Collaborators

  • Fundació d'investigació Sanitària de les Illes Balears

Registry information

Official study title

Efficacy Of Minimally Invasive Approach In The Mucosal Advancement Flap Technique For The Surgical Treatment Of Previously Untreated Complex Perianal Fistula

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Jul 3, 2024
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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