Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2026-03-09 @ 11:21 AM
Study NCT ID:
NCT03909360
Status:
UNKNOWN
Last Update Posted:
2019-04-16
First Post:
2019-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Drainage or Not for Laparoscopic Cholecystetomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002764', 'term': 'Cholecystitis'}, {'id': 'D041761', 'term': 'Cholecystolithiasis'}], 'ancestors': [{'id': 'D005705', 'term': 'Gallbladder Diseases'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002769', 'term': 'Cholelithiasis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-03-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2020-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-04-12', 'studyFirstSubmitDate': '2019-03-17', 'studyFirstSubmitQcDate': '2019-04-08', 'lastUpdatePostDateStruct': {'date': '2019-04-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'bleeding Bile leakage', 'timeFrame': 'day 1 to one month post LC operation', 'description': 'the morbidity of bleeding\n\nthe morbidity of bile leakage'}, {'measure': 'bile leakage', 'timeFrame': 'day 1 to one month post LC operation', 'description': 'the morbidity of bile leakage'}, {'measure': 'Puncture drainage Puncture drainage', 'timeFrame': 'day 1 to one month post LC operation', 'description': 'the percentage of puncture drainage\n\nPuncture drainage\n\nPuncture drainage'}, {'measure': 'reoperation Reoperation', 'timeFrame': 'day 1 to one month post LC operation', 'description': 'the percentage of reoperation'}, {'measure': 'readmission', 'timeFrame': 'day 1 to one month post LC operation', 'description': 'the percentage of readmission'}], 'secondaryOutcomes': [{'measure': 'hospital stay', 'timeFrame': 'day 1 to discharge post LC operation', 'description': 'hospital stay'}, {'measure': 'Hospitalization expenses', 'timeFrame': 'day 1 to discharge post LC operation', 'description': 'Hospitalization expenses'}, {'measure': 'VAS score', 'timeFrame': 'day 1 to discharge post LC operation', 'description': 'VAS score'}, {'measure': 'Nausea and vomiting', 'timeFrame': 'day 1 to discharge post LC operation', 'description': 'the morbidity of Nausea and vomiting'}, {'measure': 'infection', 'timeFrame': 'day 1 to discharge post LC operation', 'description': 'the morbidity of infection (abdominal, incision,pulmonary,et al)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cholecystitis', 'Cholecystolithiasis', 'Polyps Gallbladder', 'Adenomyosis of Gallbladder']}, 'referencesModule': {'references': [{'pmid': '36856748', 'type': 'DERIVED', 'citation': 'Zhu H, Liu D, Zhou D, Wu J, Yu Y, Jin Y, Ye D, Ding C, Zhang X, Huang B, Peng S, Li J. Effectiveness of no drainage after elective day-case laparoscopic cholecystectomy, even with intraoperative gallbladder perforation: a randomized controlled trial. Langenbecks Arch Surg. 2023 Mar 1;408(1):112. doi: 10.1007/s00423-023-02846-z.'}]}, 'descriptionModule': {'briefSummary': 'Surgeons usually choosing drainage tube for laparoscopic cholecystectomy according to their experiences but not guidelines. The investigators design a RCT to evaluate the role of drainage in LC surgery and compare the clinical results between drainage and no drainage.', 'detailedDescription': 'The investigators design a RCT to evaluate the role of drainage in LC surgery and compare the clinical results between drainage and no drainage.\n\nCompare complications as below betwwen drainage and no drainage groups.\n\n1. VAS\n2. Nause and vomiting\n3. infection\n4. bleeding\n5. bile leakage\n6. puncture drainage\n7. readmission\n8. reoperation\n9. hospital stay\n10. hospital expense'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age:18-75 years old\n* indicated and planed to receive laparoscopic cholecystectomy\n\nExclusion Criteria:\n\n* cirrohosis Child Grading B and C\n* upper abdominal surgery history\n* adjustment of surgical name intraoperative'}, 'identificationModule': {'nctId': 'NCT03909360', 'briefTitle': 'Drainage or Not for Laparoscopic Cholecystetomy', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': 'Role of Abdominal Drainage for Laparoscopic Cholecystectomy a Prospective Randomised Study', 'orgStudyIdInfo': {'id': 'zyeyLCdrainage'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'drainage', 'description': 'Placement of subhepatic drainage tube for laparoscopic cholecytetomy', 'interventionNames': ['Procedure: drainage tube']}, {'type': 'NO_INTERVENTION', 'label': 'no drainage', 'description': 'no placement of subhepatic drainage tube for laparoscopic cholecytetomy'}], 'interventions': [{'name': 'drainage tube', 'type': 'PROCEDURE', 'description': 'sub-hepatic drainage tube for laparoscopic cholecystectomy', 'armGroupLabels': ['drainage']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310009', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Huanbing Zhu', 'role': 'CONTACT', 'email': 'juvanbn@msn.com', 'phone': '15857174159'}], 'facility': 'The second affiliated hospital of Zhejiang University School of Medicine', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Huanbing Zhu, MD', 'role': 'CONTACT', 'email': 'juvanbn@msn.com', 'phone': '15857174159'}], 'overallOfficials': [{'name': 'Jiangtao Li, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}