Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2026-02-22 @ 8:20 AM
Study NCT ID:
NCT02652702
Status:
TERMINATED
Last Update Posted:
2020-07-07
First Post:
2015-12-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Comparing Circular Stapler-assisted Colostomy vs Hand-stitching Colostomy of Colorectal Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'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': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'whyStopped': 'Not enough patients recruited', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-01', 'studyFirstSubmitDate': '2015-12-29', 'studyFirstSubmitQcDate': '2016-01-09', 'lastUpdatePostDateStruct': {'date': '2020-07-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-01-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'colostomy associated complications', 'timeFrame': '2 year', 'description': 'measure the colostomy associated complications,such like hemorrhage,necrosis, stenosis, prolapse, and para-stomal hernia.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['circular stapler-assisted colostomy'], 'conditions': ['Colorectal Carcinoma']}, 'descriptionModule': {'briefSummary': 'Conventional hand-stitching colostomy involves extensive hand-stitching by the surgeon. There are significant variations in the outcome of surgery due to differences in the suture techniques of surgeons. The use of a circular stapler in colostomy seems more rapid and efficient colostomy than the conventional methods.But all those reports are single center retrospective cohort study，no randomized controlled trials have been carried out so far.The aim of this study is to comparing the safety and efficiency of circular stapler-assisted colostomy with conventional hand-stitching colostomy in patients with colorectal carcinoma.', 'detailedDescription': 'It has been difficult to standardize the pull-out of the colon and the size, shape and sutures of the colostomy due to the different techniques employed and varying levels of skill of surgeons in different regions.Thus, various postoperative colostomy complications are inevitable after surgery. Surgeons have been looking for a simple and efficient way to standardize colostomy and reduce its complications.\n\nSo we want to compare the safety and efficiency of circular stapler-assisted colostomy with conventional hand-stitching colostomy in colorectal cancer patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Receiving permanent colostomy because of colorectal cancer\n* Age of ≥18 and ≤80\n\nExclusion Criteria:\n\n* Not willing or incapable to comply with all study visits and assessments\n* Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that puts the patient at high risk for treatment-related complications'}, 'identificationModule': {'nctId': 'NCT02652702', 'acronym': 'STAPLER', 'briefTitle': 'Study Comparing Circular Stapler-assisted Colostomy vs Hand-stitching Colostomy of Colorectal Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'Zhejiang University'}, 'officialTitle': 'Randomized Clinical Trial Comparing the Safety and Efficiency of Circular Stapler-assisted Colostomy With Hand-stitching Colostomy for Colorectal Cancer Patients', 'orgStudyIdInfo': {'id': 'CRCCZ-D01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Circular Stapler-assisted Colostomy', 'description': 'Using Circular Stapler-assisted Technique to Finish Colostomy after colorectal carcinoma surgery when patient need permanent sigmoid stoma.', 'interventionNames': ['Procedure: circular stapler-assisted colostomy']}, {'type': 'EXPERIMENTAL', 'label': 'Hand-stitching Colostomy', 'description': 'Using Conventional Hand-stitching Technique to Finish Colostomy after colorectal carcinoma surgery when patient need permanent sigmoid stoma.', 'interventionNames': ['Procedure: conventional hand-stitching colostomy']}], 'interventions': [{'name': 'circular stapler-assisted colostomy', 'type': 'PROCEDURE', 'description': 'procedure:circular stapler-assisted colostomy device:circular stapler', 'armGroupLabels': ['Circular Stapler-assisted Colostomy']}, {'name': 'conventional hand-stitching colostomy', 'type': 'PROCEDURE', 'description': 'procedure:hand-stitching colostomy', 'armGroupLabels': ['Hand-stitching Colostomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310999', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Second Affiliated Hospital Zhejiang University College of Medicine', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ding Ke-Feng', 'investigatorAffiliation': 'Zhejiang University'}}}}