Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-27 @ 11:56 PM
Study NCT ID:
NCT07102134
Status:
COMPLETED
Last Update Posted:
2025-08-03
First Post:
2025-07-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Modified Clipped-LIFT Procedure for High Transsphincteric or Suprasphincteric Fistula
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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-06-25', 'size': 102405, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-07-28T22:09', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 96}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-05-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-01', 'studyFirstSubmitDate': '2025-07-28', 'studyFirstSubmitQcDate': '2025-08-01', 'lastUpdatePostDateStruct': {'date': '2025-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the one-stage healing rate', 'timeFrame': 'Complete wound healing without discharge more than 6 months after the modified LIFT procedure'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['High anal fistula; Ligation of the Intersphincteric Fistula Tract procedure; Sphincter-preserving; Clipped ligation.'], 'conditions': ['Anal Fistula Surgery', 'Anal Fistula']}, 'descriptionModule': {'briefSummary': 'A retrospective analysis was performed on 96 patients who underwent modified LIFT procedures to treat transsphincteric or suprasphincteric fistulas. Two distinct methods were utilized to ligate the internal sphincter side of the intersphincteric tract: one group received conventional ligation with absorbable sutures (Suturing-LIFT, n=74), while the other group was treated with absorbable clips commonly used for vascular or biliary duct occlusion (Clipped-LIFT, n=22). The primary outcome was the one-stage healing rate, which was compared between the two groups, and the safety profile of the clipped-LIFT approach was analyzed. Both univariate and multivariate analyses were conducted to identify potential prognostic factors associated with therapeutic outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* (1) preoperative pelvic MRI confirming Parks classification; (2) all patients undergoing a modified LIFT procedure, either with suture ligation (suturing-LIFT group) or clip ligation (clipped-LIFT group).\n\nExclusion Criteria:\n\n* (1) presence of secondary rectal or anal openings identified as unsuitable for LIFT during postoperative evaluation; (2) lack of clinical outcomes following initial modified LIFT procedure.'}, 'identificationModule': {'nctId': 'NCT07102134', 'briefTitle': 'The Modified Clipped-LIFT Procedure for High Transsphincteric or Suprasphincteric Fistula', 'organization': {'class': 'OTHER', 'fullName': 'Sixth Affiliated Hospital, Sun Yat-sen University'}, 'officialTitle': 'The Modified Clipped Ligation of Intersphincteric Fistula Tract (Clipped-LIFT) for High Transsphincteric or Suprasphincteric Fistula: a Proof-of-concept Study', 'orgStudyIdInfo': {'id': '2024ZSLYEC-053'}, 'secondaryIdInfos': [{'id': '1010PY(2023)-03', 'type': 'OTHER_GRANT', 'domain': 'Sixth Affiliated Hospital of Sun Yat-Sen University Clinical Research -\'1010\'Program"'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Suturing-LIFT', 'description': 'This group received conventional ligation with absorbable sutures', 'interventionNames': ['Procedure: Suturing-LIFT procedure']}, {'type': 'EXPERIMENTAL', 'label': 'Clipped-LIFT', 'description': 'This group was treated with absorbable clips commonly used for vascular or biliary duct occlusion', 'interventionNames': ['Procedure: Clipped-LIFT procedure']}], 'interventions': [{'name': 'Suturing-LIFT procedure', 'type': 'PROCEDURE', 'description': 'This group received conventional ligation with absorbable sutures', 'armGroupLabels': ['Suturing-LIFT']}, {'name': 'Clipped-LIFT procedure', 'type': 'PROCEDURE', 'description': 'This group was treated with absorbable clips commonly used for vascular or biliary duct occlusion', 'armGroupLabels': ['Clipped-LIFT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510655', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Sixth Affiliated Hospital, Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sixth Affiliated Hospital, Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}