Ignite Creation Date:
2025-12-24 @ 11:48 AM
Ignite Modification Date:
2026-01-31 @ 11:52 PM
Study NCT ID:
NCT03074461
Status:
UNKNOWN
Last Update Posted:
2017-06-01
First Post:
2017-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transverse Coloplasty vs. Side-to-end Anastomosis Following Low Anterior Resection (LAR): CSAR Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012004', 'term': 'Rectal Neoplasms'}, {'id': 'D005242', 'term': 'Fecal Incontinence'}], 'ancestors': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'There is no masking in the CSAR Trial'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Study participants will be randomized in two parallel study arms regarding their neorectal reconstruction in low anterior resection, the experimental arm using the side-to-end anastomosis and the control group using the transverse coloplasty technique.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-04-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2020-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-05-31', 'studyFirstSubmitDate': '2017-02-26', 'studyFirstSubmitQcDate': '2017-03-03', 'lastUpdatePostDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stool frequency', 'timeFrame': 'time = 6 months postoperative', 'description': 'Between group differences in stool frequency at t = 6 months postoperative'}], 'secondaryOutcomes': [{'measure': 'Postoperative complications', 'timeFrame': 'through study completion (an average of 12 months postoperative)', 'description': '* Septic intraabdominal complications related to anastomosis (anastomotic insufficiencies, suture insufficiencies, abscesses);\n* Wound infection'}, {'measure': 'Quality of Life', 'timeFrame': 'baseline, postoperative (2-3 months, 6 months, 12 months)', 'description': 'Quality of Life with focus on colorectally specialized questionnaires'}, {'measure': 'Antimotility drug usage', 'timeFrame': 'baseline, postoperative (2-3 months, 6 months, 12 months)', 'description': 'Usage of antimotility drugs (e.g. loperamide) evaluated by standardized questionnaires'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Rectal Cancer', 'Low Anterior Resection', 'Coloplasty Pouch', 'Side-to-end Anastomosis', 'Continence', 'Quality of Life'], 'conditions': ['Rectal Cancer', 'Rectal Neoplasms', 'Rectal Tumors', 'Fecal Incontinence']}, 'descriptionModule': {'briefSummary': "CSAR Trial's aim is to determine whether the transverse coloplasty pouch or the side-to-end anastomosis as rectal reservoir reconstruction offers the best functional results.", 'detailedDescription': 'This study directly compares two neorectal reservoir-techniques, the transverse coloplasty and the side-to-end anastomosis, in low anterior resection in distal rectal cancer for the first time. Its focus is on the functional results. Besides stool frequency, the quality of life, safety of the procedures and the usage of stool modulating drugs is monitored in an 12 months-follow up regime.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Scheduled low anterior resection in patients with distal rectal carcinoma and planned anastomosis in mid/distal third of rectum\n* Local curative approach\n* Normal continence preoperatively\n* Non-IBD-associated carcinoma\n* Possible sphincter salvage\n* Signed informed consent\n\nExclusion Criteria:\n\n* Non-curative approaches\n* Emergency surgery in cases of tumor perforation, abscess, sepsis\n* Proximal rectal carcinoma (\\> 12 cm from anocutaneous line)\n* Lack of informed consent\n* Age \\<18 years\n* Inclusion in other trials with interference of endpoints\n* Life expectancy less than 24 months (as estimated by the treating physicians)\n* Pregnancy\n* Immunosuppression'}, 'identificationModule': {'nctId': 'NCT03074461', 'acronym': 'CSAR', 'briefTitle': 'Transverse Coloplasty vs. Side-to-end Anastomosis Following Low Anterior Resection (LAR): CSAR Trial', 'organization': {'class': 'OTHER', 'fullName': 'Ludwig-Maximilians - University of Munich'}, 'officialTitle': 'Transverse Coloplasty vs. Side-to-end Anastomosis Following Low Anterior Resection (LAR): CSAR Trial', 'orgStudyIdInfo': {'id': '17-129'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Side-to-End', 'description': 'Side-to-End Anastomosis as neorectal reconstruction technique in low anterior resection (LAR)', 'interventionNames': ['Procedure: Side-to-End Anastomosis']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Transverse Coloplasty', 'description': 'Transverse Coloplasty pouch as neorectal reconstruction technique in low anterior resection (LAR)', 'interventionNames': ['Procedure: Transverse Coloplasty']}], 'interventions': [{'name': 'Side-to-End Anastomosis', 'type': 'PROCEDURE', 'description': 'During the scheduled low anterior resection (LAR) in patients with distal rectal cancer and anticipated anastomosis in the mid or distal rectal third, the reconstruction phase of the LAR consists of the implementation of a side-to-end colorectal anastomosis.', 'armGroupLabels': ['Side-to-End']}, {'name': 'Transverse Coloplasty', 'type': 'PROCEDURE', 'otherNames': ['Coloplasty Pouch, Transverse Coloplasty Pouch'], 'description': 'During the scheduled low anterior resection (LAR) in patients with distal rectal cancer and anticipated anastomosis in the mid or distal rectal third, the reconstruction phase of the LAR consists of the implementation of a transverse coloplasty pouch. For this purpose an end-to-end colorectal anastomosis is initially performed, followed by a longitudinal incision of approx. 8-10 cm length proximal of the anastomosis and a subsequent transverse suture in terms of the coloplasty technique.', 'armGroupLabels': ['Transverse Coloplasty']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80336', 'city': 'München', 'state': 'Bavaria', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Andreas Hölscher, MD', 'role': 'CONTACT', 'email': 'dr.hoelscher@maria-theresia-klinik.de', 'phone': '0049/89/7207325'}, {'name': 'Carolin Orlitsch, MD', 'role': 'CONTACT', 'email': 'dr.orlitsch@maria-theresia-klinik.de', 'phone': '0049/89/7207325'}], 'facility': 'Maria-Theresia-Klinik', 'geoPoint': {'lat': 48.69668, 'lon': 13.46314}}, {'zip': '80639', 'city': 'München', 'state': 'Bavaria', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Johann Spatz, MD', 'role': 'CONTACT', 'email': 'johann.spatz@barmherzige-muenchen.de', 'phone': '0049/89/17972302'}], 'facility': 'Krankenhaus Barmherzige Brüder München', 'geoPoint': {'lat': 48.69668, 'lon': 13.46314}}, {'zip': '81377', 'city': 'München', 'state': 'Bavaria', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Markus Rentsch, MD', 'role': 'CONTACT', 'email': 'markus.rentsch@med.uni-muenchen.de', 'phone': '0049/89/4400/711213'}, {'name': 'Sandro M Hasenhütl, MD', 'role': 'CONTACT', 'email': 'sandro.hasenhuetl@med.uni-muenchen.de', 'phone': '0049/89/4400/711242'}], 'facility': 'Klinikum der Universität München', 'geoPoint': {'lat': 48.69668, 'lon': 13.46314}}], 'centralContacts': [{'name': 'Markus Rentsch, MD', 'role': 'CONTACT', 'email': 'markus.rentsch@med.uni-muenchen.de', 'phone': '0049/89/4400/711213'}, {'name': 'Sandro M Hasenhütl, MD', 'role': 'CONTACT', 'email': 'sandro.hasenhuetl@med.uni-muenchen.de', 'phone': '0049/89/4400/711242'}], 'overallOfficials': [{'name': 'Markus Rentsch, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of General, Visceral, and Transplantation Surgery'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is no plan to make individual participant data available to third parties beyond the study team.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ludwig-Maximilians - University of Munich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Markus Rentsch', 'investigatorAffiliation': 'Ludwig-Maximilians - University of Munich'}}}}