Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2026-06-11 @ 7:18 AM
Study NCT ID:
NCT02027402
Status:
COMPLETED
Last Update Posted:
2014-12-03
First Post:
2013-12-30
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effects of Drainage in Laparoscopic Cholecystectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D041881', 'term': 'Cholecystitis, Acute'}, {'id': 'D002764', 'term': 'Cholecystitis'}], 'ancestors': [{'id': 'D005705', 'term': 'Gallbladder Diseases'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017081', 'term': 'Cholecystectomy, Laparoscopic'}], 'ancestors': [{'id': 'D002763', 'term': 'Cholecystectomy'}, {'id': 'D001662', 'term': 'Biliary Tract Surgical Procedures'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D010535', 'term': 'Laparoscopy'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'gshth@catholic.ac.kr', 'phone': '821052065266', 'title': 'Teaho Hong', 'organization': "Seoul St Mary's hospital"}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '2 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Drain Insertion', 'description': "Laparoscopic cholecystectomy with drain insertion is performed in this arm.\n\nLaparoscopic cholecystectomy with drain insertion: In the drain insertion group, investigators use the closed suction drain through a lateral 5-mm trocar and placed it in Morrison's pouch.", 'otherNumAtRisk': 94, 'otherNumAffected': 9, 'seriousNumAtRisk': 98, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'no Drain Insertion', 'description': 'In this arm, investigators perform only laparoscopic cholecystectomy, and not insert a drain', 'otherNumAtRisk': 99, 'otherNumAffected': 9, 'seriousNumAtRisk': 100, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'voiding difficulty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'prolonged postoperative shoulder pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Complication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'no Drain Insertion', 'description': 'In this arm, investigators perform only laparoscopic cholecystectomy, and not insert a drain'}, {'id': 'OG001', 'title': 'Drain Insertion', 'description': "Laparoscopic cholecystectomy with drain insertion is performed in this arm.\n\nLaparoscopic cholecystectomy with drain insertion: In the drain insertion group, investigators use the closed suction drain through a lateral 5-mm trocar and placed it in Morrison's pouch."}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 weeks', 'description': 'complication is subhepatic fluid collection with abscess or subhepatic hematoma or bile leakage.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Operative Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Drain Insertion', 'description': "Laparoscopic cholecystectomy with drain insertion is performed in this arm.\n\nLaparoscopic cholecystectomy with drain insertion: In the drain insertion group, investigators use the closed suction drain through a lateral 5-mm trocar and placed it in Morrison's pouch."}, {'id': 'OG001', 'title': 'no Drain Insertion', 'description': 'In this arm, investigators perform only laparoscopic cholecystectomy, and not insert a drain'}], 'classes': [{'categories': [{'measurements': [{'value': '47.8', 'spread': '17.7', 'groupId': 'OG000'}, {'value': '43.1', 'spread': '17.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1day', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Postoperative Hospital Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Drain Insertion', 'description': "Laparoscopic cholecystectomy with drain insertion is performed in this arm.\n\nLaparoscopic cholecystectomy with drain insertion: In the drain insertion group, investigators use the closed suction drain through a lateral 5-mm trocar and placed it in Morrison's pouch."}, {'id': 'OG001', 'title': 'no Drain Insertion', 'description': 'In this arm, investigators perform only laparoscopic cholecystectomy, and not insert a drain'}], 'classes': [{'categories': [{'measurements': [{'value': '2.5', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '2.3', 'spread': '0.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2weeks', 'unitOfMeasure': 'day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Postoperative Pain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Drain Insertion', 'description': "Laparoscopic cholecystectomy with drain insertion is performed in this arm.\n\nLaparoscopic cholecystectomy with drain insertion: In the drain insertion group, investigators use the closed suction drain through a lateral 5-mm trocar and placed it in Morrison's pouch."}, {'id': 'OG001', 'title': 'no Drain Insertion', 'description': 'In this arm, investigators perform only laparoscopic cholecystectomy, and not insert a drain'}], 'classes': [{'title': '6hr after operation', 'categories': [{'measurements': [{'value': '5.0', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '5.2', 'spread': '2.4', 'groupId': 'OG001'}]}]}, {'title': '24hr after operation', 'categories': [{'measurements': [{'value': '3.9', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '2.0', 'groupId': 'OG001'}]}]}, {'title': '48hr after operation', 'categories': [{'measurements': [{'value': '2.1', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '1.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6hr after operation - 24hr after operation - 48hr after operation', 'description': 'Postoperative pain was estimated using the visual analog scale (VAS) from 0 (no pain) to 10 (worst pain imaginable) at 6, 24, and 48 hours after the operation.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Drain Insertion', 'description': "Laparoscopic cholecystectomy with drain insertion is performed in this arm.\n\nLaparoscopic cholecystectomy with drain insertion: In the drain insertion group, investigators use the closed suction drain through a lateral 5-mm trocar and placed it in Morrison's pouch."}, {'id': 'FG001', 'title': 'no Drain Insertion', 'description': 'In this arm, investigators perform only laparoscopic cholecystectomy, and not insert a drain'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '98'}, {'groupId': 'FG001', 'numSubjects': '100'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '94'}, {'groupId': 'FG001', 'numSubjects': '99'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '198', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Drain Insertion', 'description': "Laparoscopic cholecystectomy with drain insertion is performed in this arm.\n\nLaparoscopic cholecystectomy with drain insertion: In the drain insertion group, investigators use the closed suction drain through a lateral 5-mm trocar and placed it in Morrison's pouch."}, {'id': 'BG001', 'title': 'no Drain Insertion', 'description': 'In this arm, investigators perform only laparoscopic cholecystectomy, and not insert a drain'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58', 'spread': '15.6', 'groupId': 'BG000'}, {'value': '50', 'spread': '15.9', 'groupId': 'BG001'}, {'value': '54', 'spread': '16.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '92', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Korea, Republic of', 'categories': [{'measurements': [{'value': '98', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '198', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 198}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-30', 'studyFirstSubmitDate': '2013-12-30', 'resultsFirstSubmitDate': '2014-11-23', 'studyFirstSubmitQcDate': '2014-01-02', 'lastUpdatePostDateStruct': {'date': '2014-12-03', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-11-30', 'studyFirstPostDateStruct': {'date': '2014-01-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-12-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complication', 'timeFrame': '2 weeks', 'description': 'complication is subhepatic fluid collection with abscess or subhepatic hematoma or bile leakage.'}], 'secondaryOutcomes': [{'measure': 'Operative Time', 'timeFrame': '1day'}, {'measure': 'Postoperative Hospital Stay', 'timeFrame': '2weeks'}, {'measure': 'Postoperative Pain Score', 'timeFrame': '6hr after operation - 24hr after operation - 48hr after operation', 'description': 'Postoperative pain was estimated using the visual analog scale (VAS) from 0 (no pain) to 10 (worst pain imaginable) at 6, 24, and 48 hours after the operation.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Acute Cholecystitis', 'Empyema of Gallbladder', 'Abscess of Gallbladder']}, 'referencesModule': {'references': [{'pmid': '25881915', 'type': 'DERIVED', 'citation': 'Kim EY, Lee SH, Lee JS, Yoon YC, Park SK, Choi HJ, Yoo DD, Hong TH. Is routine drain insertion after laparoscopic cholecystectomy for acute cholecystitis beneficial? A multicenter, prospective randomized controlled trial. J Hepatobiliary Pancreat Sci. 2015 Jul;22(7):551-7. doi: 10.1002/jhbp.244. Epub 2015 Apr 16.'}]}, 'descriptionModule': {'briefSummary': 'During laparoscopic surgery for an acutely inflamed gallbladder, most surgeons routinely insert a drain. However, no consensus has been reached regarding the need for drainage in these cases, and the use of a drain remains controversial. This study is coordinated to find out the surgical outcomes and perioperative morbidity according to the insertion of drain after laparoscopic cholecystectomy. Investigators expect that the routine use of a drain after laparoscopic cholecystectomy for an acutely inflamed gallbladder will have no effects on the postoperative morbidity.', 'detailedDescription': 'Drain has been widely used in many abdominal surgeries for therapeutic purposes such as the removal of infected debris or abscess, and supporting the healing of leakage or fistula. Although the usability of therapeutic drain is commonly accepted, the efficacy of prophylactic drain still has been debated. Most surgeons have inserted prophylactic drain with expectations that the drain would be helpful for early detection of postoperative bleeding or leakage, and also prevention of intra-abdominal abscess through removing debris or curd. However, there are only few evidence-based studies for the actual effectiveness of prophylactic drain and the objections against the routine use of drain have been raised.\n\nMost surgeons have placed the drain after cholecystectomy with expectations that it could help to detect postoperative bleeding or bile leakage and prevent intra-abdominal infection. However, there is a lack of evidence regarding the role of drain in laparoscopic cholecystectomy for acutely inflamed gallbladder and surgeons have placed the drain based on their experiences and beliefs, not on evidence-based guidelines. In the previous retrospective study, \\[4\\] we described that the routine drain use in laparoscopic cholecystectomy for acutely inflamed gallbladder has no advantage to detect bile leak or bleeding and it was no helpful to prevent the postoperative morbidities such as intra-abdominal abscess or wound infection. The aim of present multicenter trial is to assess the value of routine drain use in laparoscopic cholecystectomy for acutely inflamed gallbladder in a large, randomized controlled prospective study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* acutely inflamed gallbladder\n\nExclusion Criteria:\n\n* chronic cholecystitis\n* gallbladder polyp or gallbladder cancer\n* the patient who underwent reduced port surgery\n* the patient who underwent common bile duct exploration during the operation\n* the patient who underwent concurrent operation\n* the patient who had past history of upper abdominal surgery\n* the patient who had a immunodeficiency state\n* the case which had a suspicion of delayed bile leakage\n* the case which had a incomplete cystic duct ligation\n* the patient who underwent open conversion surgery during the operation\n* the patient who had a high risk of bleeding'}, 'identificationModule': {'nctId': 'NCT02027402', 'briefTitle': 'Effects of Drainage in Laparoscopic Cholecystectomy', 'organization': {'class': 'OTHER', 'fullName': "Seoul St. Mary's Hospital"}, 'officialTitle': 'To Drain or Not to Drain in Laparoscopic Cholecystectomy for the Patients With Acutely Inflamed Gallbladder ; a Multicenter Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'seoul -S2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Drain insertion', 'description': 'Laparoscopic cholecystectomy with drain insertion is performed in this arm.', 'interventionNames': ['Procedure: Laparoscopic cholecystectomy with drain insertion']}, {'type': 'NO_INTERVENTION', 'label': 'no drain insertion', 'description': 'In this arm, investigators perform only laparoscopic cholecystectomy, and not insert a drain'}], 'interventions': [{'name': 'Laparoscopic cholecystectomy with drain insertion', 'type': 'PROCEDURE', 'description': 'In the drain insertion group, investigators use the closed suction drain through a lateral 5-mm trocar and placed it in right subhepatic space', 'armGroupLabels': ['Drain insertion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '137-701', 'city': 'Seoul', 'state': 'Seocho-gu, Banopo-dong', 'country': 'South Korea', 'facility': "Department of HBP Surgery, Seoul St. Mary's hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Taeho Hong', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "SeoulSt.Mary's hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Seoul St. Mary's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': "Incheon St.Mary's Hospital", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant proffesor', 'investigatorFullName': 'Taeho Hong', 'investigatorAffiliation': "Seoul St. Mary's Hospital"}}}}