Fistula PerianalNCT06484660
Efficacy Of Minimally Invasive Approach In The Surgical Treatment Of Complex Perianal Fistula
A study testing Minimally Invasive Approach In The Mucosal Advancement Flap Technique in people with Fistula Perianal, run by Hospital Son Llatzer at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fistula Perianal
- What is being tested?
- Minimally Invasive Approach In The Mucosal Advancement Flap Technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 1 Aug 2021to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Son Llatzer
Palma de Mallorca, Balearic Islands, 07198
IGNACIO FERNANDEZ HURTADO, ifernandez@hsll.es
About this study
Official title: Efficacy Of Minimally Invasive Approach In The Mucosal Advancement Flap Technique For The Surgical Treatment Of Previously Untreated 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:
Read more
- 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.
- Conditions
- Fistula Perianal
- Being tested
- Minimally Invasive Approach In The Mucosal Advancement Flap Technique
- Keywords
- Perianal Fistula, Mucosal Advancement Flap, Minimally Invasive Approach
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimally Invasive Approach In The Mucosal Advancement Flap TechniqueProcedure or 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
| Study group | Role | What they receive |
|---|---|---|
| Minimally Invasive Approach In The Mucosal Advancement Flap Technique | Experimental | Not described Receives: Procedure: Minimally Invasive Approach In The Mucosal Advancement Flap Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: six months
Secondary outcomes (4)
Postoperative pain
Pain measured in visual analogic scale (VAS). Scale: 0 to 10. Higher scores mean a worse outcome.
Measured: one week
Global morbidity
Clavien Dindo Scale. Scale: 1 to 5. Higher scores mean worse complications.
Measured: one month
Quality of life score
SF 36 questionnaire. 36 items. Higher scores mean a better quality of life.
Measured: six months
Fecal incontinence
Measured in Wexner scale. Score 0 to 20. Higher scores mean a worse outcome.
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start1 Aug 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fistula PerianalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Son Llatzer
- Sponsor type
- University, hospital or other
- Collaborators
- Fundació d'investigació Sanitària de les Illes Balears
- Responsible party
- Principal investigator, Ignacio Fernandez Hurtado, Hospital Son Llatzer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06484660
- Sponsor's protocol ID
- IB4521/21
- Status last verified
- Jun 2026
- First submitted
- 26 Jun 2024
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Of Minimally Invasive Approach In The Mucosal Advancement Flap Technique For The Surgical Treatment Of Previously Untreated Complex Perianal Fistula
- ClinicalTrials.gov ID
- NCT06484660
- Acronym / sponsor ID
- IB4521/21
- Conditions
- Fistula Perianal
- Keywords
- Perianal Fistula, Mucosal Advancement Flap, Minimally Invasive Approach
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hospital Son LlatzerUniversity, hospital or other
- Collaborators
- Fundació d'investigació Sanitària de les Illes Balears
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 3 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Minimally Invasive Approach In The Mucosal Advancement Flap Technique | Experimental | Procedure: Minimally Invasive Approach In The Mucosal Advancement Flap Technique |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- Non-cryptoglandular internal fistulous orifice (IFO).
- Extrasphincteric fistula.
- Coexistence of anal fissure.
- Coexistence of hemorrhoids tributary to surgery.
- Coexistence of anal or rectal prolapse.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Minimally Invasive Approach In The Mucosal Advancement Flap TechniqueSurgical 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 | Procedure or surgery | Minimally Invasive Approach In The Mucosal Advancement Flap Technique |
Primary outcome
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.
4 secondary outcomes
Postoperative pain
Time frame: one week
Global morbidity
Time frame: one month
Quality of life score
Time frame: six months
Fecal incontinence
Time frame: six months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Derived from this study: PubMed 42151466Fernandez-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.
- Individual participant dataSharing planned: No
Related trials for Fistula Perianal
RecruitingPhase 4
Risankizumab for Refractory Perianal Fistulizing Crohn's Disease
Crohn Disease, Perianal Fistula
Not yet recruiting
Seton Re-routing for High Perianal Fistula
High Perianal Fistula, Fistula-in-Ano
Not yet recruitingPhase 4
Antibiotics After Incision and Drainage to Prevent Fistula Formation After First Episode of Perianal Abscess
Perianal Abscess, Anal Fistula
Not yet recruiting
FiLaC and PRGF-Endoret for Multi-recurrent Cryptoglandular Perianal Fistula (PLASMA Pilot Study)
Perianal Fistula
Recruiting
Loose Seton Prior to Surgery for Single-tract Cryptoglandular Fistula vs no Seton
Cryptoglandular Perianal Fistula
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Minimally Invasive Approach In The Mucosal Advancement Flap Technique in people with Fistula Perianal, run by Hospital Son Llatzer at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ignacio Fernández_Hurtado (+34871202000 ext. 2134, ifernandez@hsll.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healing rate (time frame: six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06484660, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.