Ignite Creation Date:
2025-12-24 @ 12:36 PM
Ignite Modification Date:
2026-01-09 @ 9:20 PM
Study NCT ID:
NCT03699761
Status:
UNKNOWN
Last Update Posted:
2023-05-06
First Post:
2018-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Role of Pelvic Peritonization in Laparoscopic or Robotic Low Anterior Resection
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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2024-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-03', 'studyFirstSubmitDate': '2018-10-05', 'studyFirstSubmitQcDate': '2018-10-05', 'lastUpdatePostDateStruct': {'date': '2023-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Grade III-IV complications', 'timeFrame': '30 days', 'description': 'The rate of grade III-IV complication according to Clavien-Dindo classification after low anterior resection'}], 'secondaryOutcomes': [{'measure': 'Rate of reoperation', 'timeFrame': '30 days', 'description': 'The rate of reoperation after leakage'}, {'measure': 'Detection of inflammation markers', 'timeFrame': '7 days', 'description': 'C-reactive protein(1, 3, 5, 7 days after operation, and 1 day before discharge, all blood drawn is venous blood)'}, {'measure': 'The rate of anastomotic leakage', 'timeFrame': '30 days', 'description': 'Clinical diagnostic criteria for anastomotic leakage: 1. Abdominal and systemic infection symptoms: abdominal pain, bloating, fever, elevated white blood cells, PCT, CRP and other inflammation indicators; 2. Gas, pus, feces passing through the pelvic drainage tube, abdominal incision, etc.'}, {'measure': 'Hospital time', 'timeFrame': '30 days', 'description': 'Comparison of hospital stay between the two groups'}, {'measure': 'Overall complication rate', 'timeFrame': '30days', 'description': 'Overall complication rate include I-IV grade'}, {'measure': 'Estimated blood loss', 'timeFrame': '1 day', 'description': 'Blood loss will be measured according to the suction and the weight of wet gauze, and then minus the irrigation'}, {'measure': 'Operation time', 'timeFrame': '1 day', 'description': 'The time from start to end of surgery'}, {'measure': 'Postoperative bleeding', 'timeFrame': '7 days', 'description': 'Postoperative intra-abdominal bleeding'}, {'measure': 'Intestinal obstruction', 'timeFrame': '30 days', 'description': 'Incidence of intestinal obstruction caused by various reasons after surgery'}, {'measure': 'Readmission rate', 'timeFrame': '30 days', 'description': 'Rate of hospital readmissions due to complications after discharge'}, {'measure': 'LARS', 'timeFrame': '12 months', 'description': 'Low Anterior resection syndrome caused by rectal surgery'}, {'measure': 'Acute inflammatory Response', 'timeFrame': '7 days', 'description': 'Procalcitonin(1, 3, 5, 7 days after operation, and 1 day before discharge, all blood drawn is venous blood)'}, {'measure': 'Acute inflammatory Response', 'timeFrame': '7 days', 'description': 'Check Neutrophils(1, 3, 5, 7 days after operation, and 1 day before discharge, all blood drawn is venous blood)'}, {'measure': 'Detection of other inflammation markers', 'timeFrame': '7 days', 'description': 'interleukin-6(1, 3, 5, 7 days after operation, and 1 day before discharge, all blood drawn is venous blood)'}, {'measure': 'Treatment cost', 'timeFrame': '30 days', 'description': 'Comparison of cost between the two groups'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Anastomotic leakage', 'Complication', 'Reoperation', 'Pelvic Peritonization'], 'conditions': ['Rectum Cancer']}, 'descriptionModule': {'briefSummary': 'A randomized controlled clinical trial to compare the short and long outcomes of low anterior resection for middle-low rectal cancer with or without pelvic peritonization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Matching the diagnostic criteria of rectal adenocarcinoma\n* Laparoscopic or robotic radical surgery for rectal cancer\n* Preoperative TNM staging T1-3N0-2M0\n* No history of malignant tumors by preoperative examination\n* Middle and low rectal cancer\n* Tumor size of 4 cm or less\n* ASA 1-3 scores\n* Written informed consent by the patient\n* The patient is willing to randomize to any group\n\nExclusion Criteria:\n\n* Previous abdominal surgery\n* Past malignant tumor history\n* Preoperative examination suggests distant metastasis\n* Be participating or have participated in other clinical studies related to rectal cancer surgery within 6 months\n* Emergency operation\n\nElimination criteria\n\n* The tumor is confirmed to be T4b during the operation or other tumors are found to be combined with other tumors during the operation\n* The anastomosis is located above the peritoneum reflex\n* Intraoperative conversion to laparotomy\n* Change the surgical method to perform Miles or Hartmann surgery\n* Postoperative pathologically confirmed non-adenocarcinoma\n* The patient asked to withdraw'}, 'identificationModule': {'nctId': 'NCT03699761', 'briefTitle': 'The Role of Pelvic Peritonization in Laparoscopic or Robotic Low Anterior Resection', 'organization': {'class': 'OTHER', 'fullName': 'Southwest Hospital, China'}, 'officialTitle': 'Evaluation of Pelvic Peritonization in Robotic or Laparoscopic Low Anterior Resection for Rectal Cancer', 'orgStudyIdInfo': {'id': 'POLAR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pelvic Peritonization', 'interventionNames': ['Procedure: Closure of the pelvic peritoneum', 'Procedure: Nonclosure of the pelvic peritoneum']}, {'type': 'NO_INTERVENTION', 'label': 'Without Pelvic Peritonization'}], 'interventions': [{'name': 'Closure of the pelvic peritoneum', 'type': 'PROCEDURE', 'description': 'Closure of the pelvic peritoneum after anastomosis for middle-low rectal caner.', 'armGroupLabels': ['Pelvic Peritonization']}, {'name': 'Nonclosure of the pelvic peritoneum', 'type': 'PROCEDURE', 'description': 'Nonclosure of the pelvic peritoneum after anastomosis for middle-low rectal caner.', 'armGroupLabels': ['Pelvic Peritonization']}]}, 'contactsLocationsModule': {'locations': [{'zip': '400038', 'city': 'Chongqing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Tang Bo, M.D/Ph.D', 'role': 'CONTACT', 'email': 'tangtbo@sina.com', 'phone': '+862368754167'}], 'facility': 'General Surgery Center of PLA', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}], 'centralContacts': [{'name': 'Tang Bo, MD', 'role': 'CONTACT', 'email': 'tangtbo@sina.cn', 'phone': '+8613883902288'}, {'name': 'Li Chuan', 'role': 'CONTACT', 'email': 'lee_tran@126.com', 'phone': '+86-18323479228'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Southwest Hospital, China', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Tang Bo', 'investigatorAffiliation': 'Southwest Hospital, China'}}}}