Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2026-02-19 @ 9:05 PM
Study NCT ID:
NCT06484660
Status:
RECRUITING
Last Update Posted:
2025-09-03
First Post:
2024-06-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy Of Minimally Invasive Approach In The Surgical Treatment Of Complex Perianal Fistula
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-26', 'studyFirstSubmitDate': '2024-06-26', 'studyFirstSubmitQcDate': '2024-07-01', 'lastUpdatePostDateStruct': {'date': '2025-09-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-07-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Healing rate', 'timeFrame': 'six months', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Postoperative pain', 'timeFrame': 'one week', 'description': 'Pain measured in visual analogic scale (VAS). Scale: 0 to 10. Higher scores mean a worse outcome.'}, {'measure': 'Global morbidity', 'timeFrame': 'one month', 'description': 'Clavien Dindo Scale. Scale: 1 to 5. Higher scores mean worse complications.'}, {'measure': 'Quality of life score', 'timeFrame': 'six months', 'description': 'SF 36 questionnaire. 36 items. Higher scores mean a better quality of life.'}, {'measure': 'Fecal incontinence', 'timeFrame': 'six months', 'description': 'Measured in Wexner scale. Score 0 to 20. Higher scores mean a worse outcome.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Perianal Fistula', 'Mucosal Advancement Flap', 'Minimally Invasive Approach'], 'conditions': ['Fistula Perianal']}, 'descriptionModule': {'briefSummary': '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.\n\nThe main question it aims to answer is:\n\n\\- 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?\n\nResearchers 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.\n\nQuality of life and global morbidity will also be analyzed.\n\nParticipants will:\n\n* Undergo surgical treatment of complex perianal fistula performed by mucosal advancement flap performed by a minimally invasive technique.\n* Attend control visits and fill in symptom forms one week, one month, three months and six months after the surgical procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age older than 18.\n* Present with a complex perianal fistula not surgically treated with curative intention.\n* Present only one main fistulous tract.\n* Mucosal advancement flap as the chosen technique for the treatment of the fistula.\n* Patient has given informed consent to participate in the study.\n\nExclusion Criteria:\n\n* Non-cryptoglandular internal fistulous orifice (IFO).\n* Extrasphincteric fistula.\n* Coexistence of anal fissure.\n* Coexistence of hemorrhoids tributary to surgery.\n* Coexistence of anal or rectal prolapse.\n* Coexistence of inflammatory bowel disease.\n* Coexistence of anal or colorrectal cancer.'}, 'identificationModule': {'nctId': 'NCT06484660', 'briefTitle': 'Efficacy Of Minimally Invasive Approach In The Surgical Treatment Of Complex Perianal Fistula', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Son Llatzer'}, 'officialTitle': 'Efficacy Of Minimally Invasive Approach In The Mucosal Advancement Flap Technique For The Surgical Treatment Of Previously Untreated Complex Perianal Fistula', 'orgStudyIdInfo': {'id': 'IB4521/21'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Minimally Invasive Approach In The Mucosal Advancement Flap Technique', 'interventionNames': ['Procedure: Minimally Invasive Approach In The Mucosal Advancement Flap Technique']}], 'interventions': [{'name': 'Minimally Invasive Approach In The Mucosal Advancement Flap Technique', 'type': 'PROCEDURE', 'description': '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', 'armGroupLabels': ['Minimally Invasive Approach In The Mucosal Advancement Flap Technique']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07198', 'city': 'Palma de Mallorca', 'state': 'Balearic Islands', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'IGNACIO FERNANDEZ HURTADO', 'role': 'CONTACT', 'email': 'ifernandez@hsll.es'}], 'facility': 'Hospital Son Llatzer', 'geoPoint': {'lat': 39.56939, 'lon': 2.65024}}], 'centralContacts': [{'name': 'Ignacio Fernández_Hurtado', 'role': 'CONTACT', 'email': 'ifernandez@hsll.es', 'phone': '+34871202000', 'phoneExt': '2134'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Son Llatzer', 'class': 'OTHER'}, 'collaborators': [{'name': "Fundació d'investigació Sanitària de les Illes Balears", 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Specialist in General Surgery. Specialist in Digestive Surgery', 'investigatorFullName': 'Ignacio Fernandez Hurtado', 'investigatorAffiliation': 'Hospital Son Llatzer'}}}}