Ignite Creation Date:
2025-12-24 @ 9:18 PM
Ignite Modification Date:
2026-01-06 @ 2:03 PM
Study NCT ID:
NCT00981604
Status:
COMPLETED
Last Update Posted:
2011-12-13
First Post:
2009-09-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Single Incision Laparoscopic Surgery (SILS) Versus Laparoscopic Cholecystectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002769', 'term': 'Cholelithiasis'}, {'id': 'D001657', 'term': 'Biliary Dyskinesia'}], 'ancestors': [{'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D003137', 'term': 'Common Bile Duct Diseases'}, {'id': 'D001649', 'term': 'Bile Duct 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-12', 'completionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-12-12', 'studyFirstSubmitDate': '2009-09-21', 'studyFirstSubmitQcDate': '2009-09-21', 'lastUpdatePostDateStruct': {'date': '2011-12-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Operative Time', 'timeFrame': '1 day'}], 'secondaryOutcomes': [{'measure': 'Operative complications', 'timeFrame': '2 weeks'}, {'measure': 'length of hospitalization', 'timeFrame': '1 week'}, {'measure': 'doses of analgesics', 'timeFrame': '1 week'}, {'measure': 'hospital/operation charges', 'timeFrame': '1 week'}, {'measure': 'surgeon perception of difficulty', 'timeFrame': '1 day'}, {'measure': 'cosmetic scores', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['SILS', 'Laparoscopic Cholecystectomy', 'Children'], 'conditions': ['Cholelithiasis', 'Biliary Dyskinesia']}, 'referencesModule': {'references': [{'pmid': '23331817', 'type': 'DERIVED', 'citation': 'Ostlie DJ, Juang OO, Iqbal CW, Sharp SW, Snyder CL, Andrews WS, Sharp RJ, Holcomb GW 3rd, St Peter SD. Single incision versus standard 4-port laparoscopic cholecystectomy: a prospective randomized trial. J Pediatr Surg. 2013 Jan;48(1):209-14. doi: 10.1016/j.jpedsurg.2012.10.039.'}]}, 'descriptionModule': {'briefSummary': 'Prospective randomized trial of single incision versus standard 4 port laparoscopic cholecystectomy. Hypothesis is that the operative time will be longer with single incision.', 'detailedDescription': 'This will be a prospective, randomized clinical trial involving patients who present to the hospital with an indication for cholecystectomy. We will offer enrollment to several institutions provided they receive institutional approval.\n\nThis will be a definitive trial design. Based on our operative times with SILS compared with our recent experience in standard laparoscopy, a sample size of 60 patients will give us a power of 0.8 with an α of 0.05.\n\nAfter the procedure, both groups will be managed in the same manner per routine care. They will be discharged when tolerating a regular diet and their pain is well-controlled on oral pain medication.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Need for cholecystectomy\n\nExclusion Criteria:\n\n* Need for cholangiogram'}, 'identificationModule': {'nctId': 'NCT00981604', 'acronym': 'SILS', 'briefTitle': 'Single Incision Laparoscopic Surgery (SILS) Versus Laparoscopic Cholecystectomy', 'organization': {'class': 'OTHER', 'fullName': "Children's Mercy Hospital Kansas City"}, 'officialTitle': 'Single Incision Versus Laparoscopic Cholecystectomy', 'orgStudyIdInfo': {'id': '09 07 132'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'SILS Cholecystectomy', 'description': 'Single Incision Laparoscopic Cholecystectomy', 'interventionNames': ['Procedure: SILS']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Laparoscopic Cholecystectomy', 'description': '4 port laparoscopic cholecystectomy', 'interventionNames': ['Procedure: Standard Laparoscopic Cholecystectomy']}], 'interventions': [{'name': 'SILS', 'type': 'PROCEDURE', 'description': 'Single Incision Laparoscopic Cholecystectomy', 'armGroupLabels': ['SILS Cholecystectomy']}, {'name': 'Standard Laparoscopic Cholecystectomy', 'type': 'PROCEDURE', 'otherNames': ['Laparoscopic Cholecystectomy'], 'description': '4 port technique', 'armGroupLabels': ['Standard Laparoscopic Cholecystectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '64108', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': "Children's Mercy Hospital", 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}], 'overallOfficials': [{'name': 'Daniel J Ostlie, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Mercy Hospital Kansas City"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Mercy Hospital Kansas City", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Shawn St. Peter', 'investigatorAffiliation': "Children's Mercy Hospital Kansas City"}}}}