Ignite Creation Date:
2025-12-26 @ 11:10 AM
Ignite Modification Date:
2025-12-26 @ 11:10 AM
Study NCT ID:
NCT04078828
Status:
UNKNOWN
Last Update Posted:
2021-11-30
First Post:
2019-08-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
PR in Endoscopic LAR for Rectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012004', 'term': 'Rectal Neoplasms'}], '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'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2022-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-11-28', 'studyFirstSubmitDate': '2019-08-15', 'studyFirstSubmitQcDate': '2019-08-31', 'lastUpdatePostDateStruct': {'date': '2021-11-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The rate of anastomotic leakage after laparoscopic anterior resection for rectal cancer', 'timeFrame': '30 days after surgery'}, {'measure': 'Re-operation rate after anastomotic leakage', 'timeFrame': '30 days after surgery'}, {'measure': 'The rate of general complications', 'timeFrame': '30 days after surgery'}], 'secondaryOutcomes': [{'measure': 'Operative time', 'timeFrame': 'Operation day'}, {'measure': 'Postoperative hospital stay', 'timeFrame': '1 year after surgery'}, {'measure': 'Incidence of defecation dysfunction', 'timeFrame': 'From the date of operation until the date of complication,assessed up to 3 years'}, {'measure': '3-year local recurrence rate', 'timeFrame': 'From date of operation until the date of local-recurrence (up to 3 years)'}, {'measure': '5-year disease-free survival', 'timeFrame': 'From date of operation until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years'}, {'measure': 'Postoperative quality of life as assessed by EORTC QLQ-C30 questionnaire', 'timeFrame': '1 year after operation'}, {'measure': 'Blood loss', 'timeFrame': 'Operation day'}, {'measure': 'White blood cells(WBC) ,C-reactive protein (CRP) and procalcitonin (PCT) count in the blood sample', 'timeFrame': '1 days after surgery'}, {'measure': 'White blood cells(WBC) ,C-reactive protein (CRP) and procalcitonin (PCT) count in the blood sample', 'timeFrame': '3 days after surgery'}, {'measure': 'White blood cells(WBC) ,C-reactive protein (CRP) and procalcitonin (PCT) count in the blood sample', 'timeFrame': '5 days after surgery'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['minimally invasive surgical'], 'conditions': ['Rectal Carcinoma']}, 'descriptionModule': {'briefSummary': 'The anastomotic leakage remains the major early complication after laparoscopic anterior resection(LAR) for medium \\& low rectal cancer. Pelvic floor reconstruction (PR) is a key step in various standard resections for open radical rectal cancer surgery, which was considered to be helpful for decreasing the rate of leakage. However, PR in endoscopic LAR surgery is not routine practice and remains controversial. The purpose of this study is to evaluate the efficacy of PR during LAR for mid/low rectal carcinoma, especially in preventing anastomotic leakage.', 'detailedDescription': 'Eligible patients with rectal cancer will be randomly assigned to group with pelvic floor reconstruction(PR) versus group without pelvic floor reconstruction(NPR).\n\nWe want to investigate the rate of anastomotic leakage and re-operation between the two groups, some other relevant outcomes will be concerned all the same.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. patients with histologically proven rectal adenocarcinoma\n2. tumor located in the middle and lower rectum and anastomosis under the peritoneal reflection\n3. Tumor assessed as a depth of invasion that was confined to pT1-pT3, bN0-1M0 by ultrasound colonoscopy and/or pelvic MRI\n4. Negative circumferential resection margin confirmed by MRI\n5. Performance status (ECOG) 0\\~1\n6. Written informed consent for participation in the trial\n\nExclusion Criteria:\n\n1. History of accepting lower abdominal surgery.\n2. More than one colorectal tumor\n3. Patients with unresectable distant metastasis or multiple metastases\n4. Received neoadjuvant radiotherapy before surgery\n5. Signs of acute intestinal obstruction, bleeding or perforation needing emergency surgery\n6. Patients and/or family members cannot understand and accept this study\n7. Non-rectal adenocarcinoma was confirmed by postoperative pathological examination'}, 'identificationModule': {'nctId': 'NCT04078828', 'briefTitle': 'PR in Endoscopic LAR for Rectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Southwest Hospital, China'}, 'officialTitle': 'Pelvic Floor Reconstruction (PR) in Endoscopic Low Anterior Resection for Rectal Cancer', 'orgStudyIdInfo': {'id': 'PRLAR-SURGERY'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'PR', 'interventionNames': ['Procedure: Pelvic floor Reconstruction']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Non-PR', 'interventionNames': ['Procedure: Pelvic floor Reconstruction']}], 'interventions': [{'name': 'Pelvic floor Reconstruction', 'type': 'PROCEDURE', 'description': 'Pelvic floor Reconstruction after laparoscopic anterior resection and double-stapling technique anastomosis were finished.', 'armGroupLabels': ['Non-PR', 'PR']}]}, 'contactsLocationsModule': {'locations': [{'zip': '400038', 'city': 'Chongqing', 'state': 'Chongqing Municipality', '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.com', 'phone': '+862368754167'}, {'name': 'Li Chuan, MD', 'role': 'CONTACT', 'email': '79168391@qq.com', 'phone': '+862368754167'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Southwest Hospital, China', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Secretary of General Surgery', 'investigatorFullName': 'Li Chuan', 'investigatorAffiliation': 'Southwest Hospital, China'}}}}