Ignite Creation Date:
2025-12-24 @ 12:42 PM
Ignite Modification Date:
2026-01-21 @ 6:50 PM
Study NCT ID:
NCT06553261
Status:
RECRUITING
Last Update Posted:
2024-08-14
First Post:
2024-08-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anastomotic Leakage in Right Colectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057868', 'term': 'Anastomotic Leak'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007507', 'term': 'Therapeutic Irrigation'}, {'id': 'D004322', 'term': 'Drainage'}], 'ancestors': [{'id': 'D006875', 'term': 'Hydrotherapy'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3446}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-12-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-11', 'studyFirstSubmitDate': '2024-08-11', 'studyFirstSubmitQcDate': '2024-08-11', 'lastUpdatePostDateStruct': {'date': '2024-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical outcome', 'timeFrame': '2010-2019', 'description': 'Survival or death'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anastomotic Leak']}, 'descriptionModule': {'briefSummary': 'Data of patients undergoing elective right colectomy for benign and malignant disease using an open or laparoscopic approach are to be collected in seven colorectal units among Austria for the period between January 2010 and December 2019. Demographic, peri- and postoperative data of patients were analyzed retrospectively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with benign or malignant diseases in the right colon.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with benign or malignant diseases in the right portion of the colon.\n* elective surgery\n\nExclusion Criteria:\n\n* emergent surgery'}, 'identificationModule': {'nctId': 'NCT06553261', 'briefTitle': 'Anastomotic Leakage in Right Colectomy', 'organization': {'class': 'OTHER', 'fullName': 'Barmherzige Brüder Vienna'}, 'officialTitle': 'Open Versus Laparoscopic Right Colectomy: Does the Initial Approach Impact on Management and Outcome in Anastomotic Leakage? A Multicenter Cohort Study', 'orgStudyIdInfo': {'id': 'LEAK1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients after laparoscopic right hemicolectomy', 'description': 'Patients who had undergone a laparoscopic tight colectomy and had anastomotic leak.', 'interventionNames': ['Procedure: suturing of leak, lavage, drainage', 'Procedure: Formation of a new anasthomosis', 'Procedure: Fecal diversion']}, {'label': 'Patients after open right hemicolectomy', 'description': 'Patients who had undergone a laparoscopic tight colectomy and had anastomotic leak.', 'interventionNames': ['Procedure: suturing of leak, lavage, drainage', 'Procedure: Formation of a new anasthomosis', 'Procedure: Fecal diversion']}], 'interventions': [{'name': 'suturing of leak, lavage, drainage', 'type': 'PROCEDURE', 'description': 'Operative suturing of the leak, lavage, drainage within a revision surgery.', 'armGroupLabels': ['Patients after laparoscopic right hemicolectomy', 'Patients after open right hemicolectomy']}, {'name': 'Formation of a new anasthomosis', 'type': 'PROCEDURE', 'description': 'Operative resection of the old leaking anastomosis and formation of a new one.', 'armGroupLabels': ['Patients after laparoscopic right hemicolectomy', 'Patients after open right hemicolectomy']}, {'name': 'Fecal diversion', 'type': 'PROCEDURE', 'description': 'Formation of a deviating stoma.', 'armGroupLabels': ['Patients after laparoscopic right hemicolectomy', 'Patients after open right hemicolectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1020', 'city': 'Vienna', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Benhard Dauser, Assoc. Prof.', 'role': 'CONTACT', 'email': 'bernhard.dauser@gmail.com', 'phone': '0043 1 211210', 'phoneExt': '5098'}, {'name': 'Iliyan Iliev, MD', 'role': 'CONTACT', 'email': 'iliyaniliev18s@gmail.com', 'phone': '0043 6607435277'}], 'facility': 'Krankenhaus der Barmherzigen Brüder', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'centralContacts': [{'name': 'Bernhard Dauser, Assoc. Prof.', 'role': 'CONTACT', 'email': 'bernhard.dauser@gmail.com', 'phone': '0043 1 211210', 'phoneExt': '5098'}, {'name': 'ILIYAN ILIEV, MD', 'role': 'CONTACT', 'email': 'iliyaniliev18s@gmail.com', 'phone': '0043 6607435277'}], 'overallOfficials': [{'name': 'Bernhard Dauser, Assoc. Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Krankenhaus der Barmherzigen Brüder Vienna'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Barmherzige Brüder Vienna', 'class': 'OTHER'}, 'collaborators': [{'name': 'Barmherzige Brüder Salzburg', 'class': 'OTHER'}, {'name': 'Kepler University Hospital', 'class': 'OTHER'}, {'name': 'University of Salzburg', 'class': 'OTHER'}, {'name': 'Hospital Barmherzige Schwestern Vienna', 'class': 'OTHER'}, {'name': 'Medical University of Vienna', 'class': 'OTHER'}, {'name': 'University Hospital, Saarland', 'class': 'OTHER'}, {'name': 'Sigmund Freud PrivatUniversitat', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'ILIYAN ILIEV', 'investigatorAffiliation': 'Barmherzige Brüder Vienna'}}}}