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RecruitingNCT06484660Updated Jul 7, 2026

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

An interventional study of Minimally Invasive Approach In The Mucosal Advancement Flap Technique in Fistula Perianal, sponsored by Hospital Son Llatzer. Recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-07.

Sponsored by Hospital Son Llatzer · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 10 months after the study started (first participant enrolled Aug 2021, registered Jun 2024).
  • Started Aug 2021; still recruiting 5 years 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

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.
02

Conditions studied

  • Fistula Perianal

Keywords

  • Perianal Fistula
  • Mucosal Advancement Flap
  • Minimally Invasive Approach
03

In context

Lead sponsor

Hospital Son Llatzer is the lead sponsor of 16 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Minimally Invasive Approach In The Mucosal Advancement Flap Technique

    Procedure: Minimally Invasive Approach In The Mucosal Advancement Flap Technique

Interventions

  • ProcedureMinimally 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

06

What researchers measure

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

07

Study locations

1 of 1 sites recruiting
  • Hospital Son Llatzer
    Palma de Mallorca, Balearic Islands 07198, Spain
    Recruiting
08

References and documents

Publications

  • Fernandez-Hurtado I, Pages-Valle N, Castro-Suarez M, Sarubbo MF, Baena-Bradaschia S, Cifuentes-Rodenas JA, Serra-Aracil X. Microsurgery in mucosal advancement flap repair: a microscope-assisted, tissue-sparing approach for managing complex perianal fistulas within the IDEAL Stage 1 framework. Surg Endosc. 2026 Jun;40(6):5387-5396. doi: 10.1007/s00464-026-12876-5. Epub 2026 May 18. PubMed 42151466 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06484660
Lead sponsor
Hospital Son Llatzer
Collaborators
Fundació d'investigació Sanitària de les Illes Balears
Responsible party
Ignacio Fernandez Hurtado (Specialist in General Surgery. Specialist in Digestive Surgery, Hospital Son Llatzer) — Principal investigator
First posted
Jul 3, 2024
Start date
Aug 1, 2021
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Jul 7, 2026

Study contacts

Ignacio Fernández_Hurtado
Contact
ifernandez@hsll.es
+34871202000 ext. 2134

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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