Ignite Creation Date:
2025-12-24 @ 10:32 PM
Ignite Modification Date:
2025-12-25 @ 8:05 PM
Study NCT ID:
NCT06386835
Status:
RECRUITING
Last Update Posted:
2024-04-26
First Post:
2024-04-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Collagen Paste vs Mucosal Advancement Flap for FIA
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012003', 'term': 'Rectal Fistula'}], 'ancestors': [{'id': 'D007412', 'term': 'Intestinal Fistula'}, {'id': 'D016154', 'term': 'Digestive System Fistula'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D005402', 'term': 'Fistula'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 118}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2027-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-24', 'studyFirstSubmitDate': '2024-04-22', 'studyFirstSubmitQcDate': '2024-04-24', 'lastUpdatePostDateStruct': {'date': '2024-04-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical healing of Fistula-in-ano', 'timeFrame': '1 year', 'description': 'Clinical healing of the fistula-in-ano'}], 'secondaryOutcomes': [{'measure': '30-day morbidity', 'timeFrame': '30 days', 'description': '30-day morbidity using Clavien-Dindo classification'}, {'measure': 'Quality of life score', 'timeFrame': '1 year', 'description': 'Assess effect on Quality of life post operatively using Short Form 36 Health Survey'}, {'measure': 'Postoperative pain score', 'timeFrame': '1 week', 'description': 'assessment of postoperative pain using visual analog score from 0 (no pain) to 10 (severe pain)'}, {'measure': 'Faecal incontinence rate', 'timeFrame': '1 year', 'description': 'Assess postoperative effect on continence'}, {'measure': 'Hospital readmission rate', 'timeFrame': '1 year', 'description': 'Assess hospital re-admission rate'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Fistula-in-ano']}, 'descriptionModule': {'briefSummary': 'The treatment for fistula-in-ano (FIA) remains a challenge to General and Colorectal Surgeons Worldwide. A variety of surgical treatments have been described for high anal fistulas, but none offers the panacea of fistula eradication with guaranteed preservation of continence. This study compares Collagen paste injection to mucosal advancement flap for the treatment of fistula-in-ano.', 'detailedDescription': 'Rectal advancement flaps have been advocated as a means of closing high fistulas with preservation of the external sphincter muscle. With this technique, it shows promising results with success rate of approximately 60%. However, complications have been reported, in particular with a change of continence in 30-35% of patients.\n\nCollagen paste is a novel sphincter-preserving method for fistula closure. Permacol (Medtronic, USA) is a sterile acellular cross-linked porcine dermal collagen matrix suspension. The paste-like suspension form a matrix that accelerates neovascularization, cellular infiltration which promotes healing and fistula closure. The theoretical benefits of paste form compared to previous collagen plug design is that the collagen can moulded into the fistula cavity or tract. This allows better tissue contact with the collagen thus improves healing and reduces the chance of dislodgement. Limited data is available to date. Success rates of collagen paste range from 47.6% to 63%. Hence it has a potential to be the first-line treatment for high FIA with low complication rates and without causing disruption to the anal sphincter complex.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Clinical diagnosis of high cryptoglandular fistula-in-ano.\n* Patients must have undergone a prior EUA to characterise the nature of the fistula.\n* The fistula tract should be ≥ 2 cm in length.\n* Only a single internal fistula opening should be present at EUA, such that the fistula is suitable for treatment by insertion of a seton drain.\n* Patients must have been treated with a draining seton for a minimum period of 6 weeks prior to randomisation.\n* Patients must be aged ≥ 18 years and able to provide informed consent.\n* Fistulas must be of cryptoglandular aetiology.\n\nExclusion Criteria:\n\n* Unable/unwilling to provide informed consent.\n* Contraindication to general anaesthesia or spinal anaesthesia.\n* Low trans-sphincteric fistulas.\n* Non-cryptoglandular fistulas (e.g. Crohn's disease, obstetric, irradiation, malignant, etc.).\n* Other perineal fistulas (e.g. rectovaginal fistulas, pouch-vaginal fistulas, etc.).\n* Complex disease in which more than one internal fistula opening is present and requiring concurrent insertion of more than one fistula plug.\n* Clinical evidence of active perianal sepsis. In the event that there is disagreement between clinical and radiological assessment of active sepsis/collection, the clinical opinion will prevail.\n* Cultural or religious objection to the use of pig tissue.\n* Absolute contraindication to magnetic resonance imaging (MRI) (e.g. cardiac pacemaker).\n* Patients with recurrent anal fistulas previously treated with a fistula plug."}, 'identificationModule': {'nctId': 'NCT06386835', 'briefTitle': 'Collagen Paste vs Mucosal Advancement Flap for FIA', 'organization': {'class': 'OTHER', 'fullName': 'Chinese University of Hong Kong'}, 'officialTitle': 'Collagen Paste Injection Compared With Mucosal Advancement Flap for the Treatment of Fistula-in-ano: Single Centre Non-inferiority Randomised Controlled Trial', 'orgStudyIdInfo': {'id': 'CREC2021.724-T'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Collagen Paste', 'description': 'Seton is removed, the fistula tract is de-epithelialised and collagen paste applied.', 'interventionNames': ['Procedure: Collagen Paste']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Mucosal Advancement Flap', 'description': 'The internal opening is excised and is covered with a "U-shape" rectal mucosal flap', 'interventionNames': ['Procedure: Mucosal advancement']}], 'interventions': [{'name': 'Collagen Paste', 'type': 'PROCEDURE', 'description': 'Collagen paste injection', 'armGroupLabels': ['Collagen Paste']}, {'name': 'Mucosal advancement', 'type': 'PROCEDURE', 'description': 'Mucosal advancement flap', 'armGroupLabels': ['Mucosal Advancement Flap']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shatin', 'state': 'New Territories', 'status': 'RECRUITING', 'country': 'Hong Kong', 'contacts': [{'name': 'Kaori Futaba', 'role': 'CONTACT', 'email': 'kfutaba@surgery.cuhk.edu.hk'}], 'facility': 'Department of Surgery, Chinese University of Hong Kong', 'geoPoint': {'lat': 22.38333, 'lon': 114.18333}}, {'city': 'Shatin', 'status': 'RECRUITING', 'country': 'Hong Kong', 'contacts': [{'name': 'Kaori Futaba', 'role': 'CONTACT', 'email': 'kfutaba@surgery.cuhk.edu.hk', 'phone': '35051495'}], 'facility': 'Prince of Wlaes Hospital', 'geoPoint': {'lat': 22.38333, 'lon': 114.18333}}], 'centralContacts': [{'name': 'Kaori Futaba, FRCS', 'role': 'CONTACT', 'email': 'kfutaba@surgery.cuhk.edu.hk', 'phone': '35051495'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Kaori Futaba', 'investigatorAffiliation': 'Chinese University of Hong Kong'}}}}