Ignite Creation Date:
2025-12-24 @ 5:40 PM
Ignite Modification Date:
2025-12-30 @ 6:00 AM
Study NCT ID:
NCT02905968
Status:
UNKNOWN
Last Update Posted:
2016-09-19
First Post:
2016-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transanual Tube Placement in Low Anterior Resection (LAR) for Rectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012004', 'term': 'Rectal Neoplasms'}, {'id': 'D057868', 'term': 'Anastomotic Leak'}], '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'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 520}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-09-14', 'studyFirstSubmitDate': '2016-09-08', 'studyFirstSubmitQcDate': '2016-09-14', 'lastUpdatePostDateStruct': {'date': '2016-09-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-09-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'anastomotic leak rate', 'timeFrame': '30 days post operatively', 'description': 'Anastomotic leak is a common and serious complication after low anterior, resection, and often leads to re-operation.'}], 'secondaryOutcomes': [{'measure': 'Time Frame: Reoperation rate after anastomotic leak', 'timeFrame': '30 days post operatively', 'description': 'Anastomotic leak is a common and serious complication after low anterior, resection, and often leads to excrement peritonitis, and re-operation as colostomy'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Anastomotic leak', 'Low rectal cancer'], 'conditions': ['Rectal Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effectiveness of transanual tube placement in low anterior resection (LAR) for rectal cancer in preventing anastomotic leakage.', 'detailedDescription': 'Transanual tube placement after anastomosis in low anterior resection for rectal cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age ≥ 18 and ≤ 75 years;\n2. Primary tumor has undergone histologically confirmed rectal adenocarcinoma; Low rectal cancer was defined by the presence of the inferior pole of the tumor below the peritoneal reflection (in 11 cm from the anal margin).\n3. Together with clinical or radiological evidence of Stage II (T3-4, N0, M0) or Stage III (T1-4, N1-2, M0) disease (according to the 2010 revision of the International Union Against Cancer primary tumor, regional nodes, metastasis (TNM) staging system).\n4. Performance status (ECOG) 0\\~1\n5. Adequate hematological function: Neutrophils≥1.5 x109/l and platelet count≥100 x109/l; hemoglobin (Hb) ≥9g/dl (within 1 week prior to randomization)\n6. Adequate hepatic and renal function: Serum bilirubin≤1.5 x upper limit of normal (ULN), alkaline phosphatase ≤5x ULN, and serum transaminase (either primary tumor, regional nodes, metastasis (AST) or ALT) ≤ 5 x ULN(within 1 week prior to randomization);\n7. Written informed consent for participation in the trial.\n\nExclusion Criteria:\n\n1. Body mass index (BMI) more than 30 kg/m2.\n2. Serious pre-operative comorbidity, including cardiovascular disease (coronary arteriosclerosis, arrhythmia, heart failure), pulmonary dysfunction (lung emphysema, obstructive lung disease), liver insufficiency (Child-Pugh B or C), renal insufficiency (serum creatinine \\>2.0 mg/dl), and arterial circulation disturbance (occlusion of arterial vessels of limb in patient's history.\n3. History of accepting abdominal surgery."}, 'identificationModule': {'nctId': 'NCT02905968', 'briefTitle': 'Transanual Tube Placement in Low Anterior Resection (LAR) for Rectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Fudan University'}, 'officialTitle': 'The Safety and Effect of Transanual Tube Placement in Low Anterior Resection (LAR) for Rectal Cancer to Prevent Anastomotic Leak: Randomized Control Trial Study', 'orgStudyIdInfo': {'id': 'TTPLAR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TTPLAR', 'description': 'Transanual tube placement after anastomosis in low anterior resection for rectal cancer.', 'interventionNames': ['Device: transanual tube placement']}, {'type': 'NO_INTERVENTION', 'label': 'NORLAR', 'description': 'Tranditional low anterior resection without transanual tube placement or ileostomy.'}], 'interventions': [{'name': 'transanual tube placement', 'type': 'DEVICE', 'description': 'Transanual tube placement after anastomosis in low anterior resection for rectal cancer.', 'armGroupLabels': ['TTPLAR']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'jianmin xu, MD', 'role': 'CONTACT', 'email': 'xujmin@aliyun.com', 'phone': '008613501984869'}], 'facility': 'Department of General Surgery, Zhongshan Hospital, Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'jianmin Xu, MD', 'role': 'CONTACT', 'email': 'xujmin@aliyun.com', 'phone': '008613501984869'}], 'overallOfficials': [{'name': 'Tuo Yi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fudan University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fudan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof.', 'investigatorFullName': 'Xu jianmin', 'investigatorAffiliation': 'Fudan University'}}}}