Ignite Creation Date:
2025-12-24 @ 5:02 PM
Ignite Modification Date:
2025-12-27 @ 6:16 AM
Study NCT ID:
NCT00971750
Status:
COMPLETED
Last Update Posted:
2012-07-11
First Post:
2009-09-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Laparoscopic Versus Transabdominal Ultrasound in Morbidly Obese Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002769', 'term': 'Cholelithiasis'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'snkothar@gundluth.org', 'phone': '608-775-2331', 'title': 'Dr. Shanu Kothari', 'organization': 'Gundersen Lutheran Health System'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Ultrasound Study Group', 'description': 'Patients with no history of gallbladder surgery who are undergoing elective laparoscopic roux-en-Y gastric bypass that have consented to undergo a preoperative transabdominal ultrasound in addition to routine preoperative assessment for surgery.', 'otherNumAtRisk': 253, 'otherNumAffected': 0, 'seriousNumAtRisk': 253, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Cholelithiasis on Transabdominal Ultrasound Versus Laparoscopic Ultrasound.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '253', 'groupId': 'OG000'}, {'value': '253', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Transabdominal Ultrasound', 'description': 'Patients with no history of gallbladder surgery who are undergoing elective laparoscopic roux-en-Y gastric bypass that have consented to undergo a preoperative transabdominal ultrasound in addition to routine preoperative assessment for surgery.'}, {'id': 'OG001', 'title': 'Laparoscopic Ultrasound', 'description': 'Laparoscopic ultrasound is performed intraoperatively at the time of gastric bypass.'}], 'classes': [{'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.763', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'transabdominal measurements within 30 days prior to surgery; laparoscopic ultrasound measurements are completed intraoperatively', 'description': 'Number of patients with cholelithiasis.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Common Bile Duct (CBD) Diameter Measured by Transabdominal Ultrasound Versus Laparoscopic Ultrasound.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '253', 'groupId': 'OG000'}, {'value': '253', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Transabdominal Ultrasound', 'description': 'Patients with no history of gallbladder surgery who are undergoing elective laparoscopic roux-en-Y gastric bypass that have consented to undergo a preoperative transabdominal ultrasound in addition to routine preoperative assessment for surgery.'}, {'id': 'OG001', 'title': 'Laparoscopic Ultrasound', 'description': 'Laparoscopic ultrasound is performed intraoperatively during gastric bypass'}], 'classes': [{'categories': [{'measurements': [{'value': '4.0', 'spread': '1.28', 'groupId': 'OG000'}, {'value': '3.7', 'spread': '1.37', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'transabdominal measurements will be done within 30 days prior to surgery; laparoscopic ultrasound measurements are completed intraoperatively', 'description': 'Mean CBD diameter.', 'unitOfMeasure': 'millimeters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Polyps on Transabdominal and Laparoscopic Ultrasound', 'denoms': [{'units': 'Participants', 'counts': [{'value': '253', 'groupId': 'OG000'}, {'value': '253', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Transabdominal Ultrasound', 'description': 'Patients with no history of gallbladder surgery who are undergoing elective laparoscopic roux-en-Y gastric bypass that have consented to undergo a preoperative transabdominal ultrasound in addition to routine preoperative assessment for surgery.'}, {'id': 'OG001', 'title': 'Laparoscopic Ultrasound', 'description': 'Laparoscopic ultrasound is performed intraoperatively at the time of gastric bypass.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '6 years', 'description': 'Number of patients with polyps.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ultrasound Study Group', 'description': 'Patients with no history of gallbladder surgery who are undergoing elective laparoscopic roux-en-Y gastric bypass that have consented to undergo a preoperative transabdominal ultrasound in addition to routine preoperative assessment for surgery.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '253'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '253'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '253', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Ultrasound Study Group', 'description': 'Patients with no history of gallbladder surgery who are undergoing elective laparoscopic roux-en-Y gastric bypass that have consented to undergo a preoperative transabdominal ultrasound in addition to routine preoperative assessment for surgery.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '251', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '43.5', 'spread': '9.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '192', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '61', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '253', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 253}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-29', 'studyFirstSubmitDate': '2009-09-03', 'resultsFirstSubmitDate': '2012-03-23', 'studyFirstSubmitQcDate': '2009-09-03', 'lastUpdatePostDateStruct': {'date': '2012-07-11', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-05-29', 'studyFirstPostDateStruct': {'date': '2009-09-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-07-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cholelithiasis on Transabdominal Ultrasound Versus Laparoscopic Ultrasound.', 'timeFrame': 'transabdominal measurements within 30 days prior to surgery; laparoscopic ultrasound measurements are completed intraoperatively', 'description': 'Number of patients with cholelithiasis.'}, {'measure': 'Polyps on Transabdominal and Laparoscopic Ultrasound', 'timeFrame': '6 years', 'description': 'Number of patients with polyps.'}], 'secondaryOutcomes': [{'measure': 'Common Bile Duct (CBD) Diameter Measured by Transabdominal Ultrasound Versus Laparoscopic Ultrasound.', 'timeFrame': 'transabdominal measurements will be done within 30 days prior to surgery; laparoscopic ultrasound measurements are completed intraoperatively', 'description': 'Mean CBD diameter.'}]}, 'conditionsModule': {'keywords': ['ultrasonography', 'gallbladder', 'cholelithiasis', 'laparoscopic', 'gastric bypass', 'obesity', 'bariatric surgery'], 'conditions': ['Cholelithiasis', 'Ultrasonography', 'Laparoscopic Gastric Bypass']}, 'referencesModule': {'references': [{'pmid': '2122943', 'type': 'BACKGROUND', 'citation': 'Yang HL, Li ZZ, Sun YG. Reliability of ultrasonography in diagnosis of biliary lithiasis. Chin Med J (Engl). 1990 Aug;103(8):638-41.'}, {'pmid': '3532178', 'type': 'BACKGROUND', 'citation': 'Cronan JJ. US diagnosis of choledocholithiasis: a reappraisal. Radiology. 1986 Oct;161(1):133-4. doi: 10.1148/radiology.161.1.3532178.'}, {'pmid': '7979854', 'type': 'BACKGROUND', 'citation': 'Shea JA, Berlin JA, Escarce JJ, Clarke JR, Kinosian BP, Cabana MD, Tsai WW, Horangic N, Malet PF, Schwartz JS, et al. Revised estimates of diagnostic test sensitivity and specificity in suspected biliary tract disease. Arch Intern Med. 1994 Nov 28;154(22):2573-81.'}, {'pmid': '6608231', 'type': 'BACKGROUND', 'citation': 'Einstein DM, Lapin SA, Ralls PW, Halls JM. The insensitivity of sonography in the detection of choledocholithiasis. AJR Am J Roentgenol. 1984 Apr;142(4):725-8. doi: 10.2214/ajr.142.4.725.'}, {'pmid': '23571143', 'type': 'DERIVED', 'citation': 'Kothari SN, Obinwanne KM, Baker MT, Mathiason MA, Kallies KJ. A prospective, blinded comparison of laparoscopic ultrasound with transabdominal ultrasound for the detection of gallbladder pathology in morbidly obese patients. J Am Coll Surg. 2013 Jun;216(6):1057-62. doi: 10.1016/j.jamcollsurg.2013.02.009. Epub 2013 Apr 6.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to prospectively compare laparoscopic ultrasound to transabdominal ultrasound for the detection of gallbladder pathology in obese patients presenting for laparoscopic gastric bypass. We hypothesize that laparoscopic ultrasound will be more sensitive and specific for cholelithiasis than transabdominal ultrasound in morbidly obese patients.', 'detailedDescription': 'Asymptomatic cholelithiasis is a prevalent condition in obese patients presenting for bariatric surgery. Transabdominal ultrasound (TAU) remains the gold standard for detection of cholelithiasis. The sensitivity and specificity of transabdominal ultrasound for cholelithiasis reported in literature is between 88-97% and 97-99%, respectively. The ability to detect cholelithiasis with TAU in the obese population may be inhibited due to the presence of increased subcutaneous and visceral fat. Laparoscopic ultrasound (LU) has the potential to overcome these technical challenges. In an era of minimally invasive bariatric surgery, it has been suggested that routine preoperative ultrasound TAU be performed for the detection of cholelithiasis since intraoperative palpation is not feasible. We hypothesize that laparoscopic ultrasound will be more sensitive and specific for cholelithiasis than transabdominal ultrasound in morbidly obese patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Study population will consist of patients undergoing laparoscopic gastric bypass at a community-based teaching institution.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Morbidly obese patients undergoing elective laparoscopic roux-en-Y gastric bypass\n\nExclusion Criteria:\n\n* Prior history of gallbladder surgery'}, 'identificationModule': {'nctId': 'NCT00971750', 'briefTitle': 'Laparoscopic Versus Transabdominal Ultrasound in Morbidly Obese Patients', 'organization': {'class': 'OTHER', 'fullName': 'Gundersen Lutheran Medical Foundation'}, 'officialTitle': 'Comparison of Laparoscopic Ultrasound to Transabdominal Ultrasound for the Detection of Gallbladder Pathology in the Bariatric Surgical Population.', 'orgStudyIdInfo': {'id': '2-03-08-009'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Ultrasound Study Group', 'description': 'Patients with no history of gallbladder surgery who are undergoing elective laparoscopic roux-en-Y gastric bypass that have consented to undergo a preoperative transabdominal ultrasound in addition to routine preoperative assessment for surgery.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '54601', 'city': 'La Crosse', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Gundersen Lutheran Health System', 'geoPoint': {'lat': 43.80136, 'lon': -91.23958}}], 'overallOfficials': [{'name': 'Shanu N Kothari, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gundersen Lutheran Health System'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gundersen Lutheran Medical Foundation', 'class': 'OTHER'}, 'collaborators': [{'name': 'Gundersen Lutheran Health System', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Advanced Research Associate, under direction of Shanu N. Kothari, MD, (PI)', 'investigatorFullName': 'Kara Kallies', 'investigatorAffiliation': 'Gundersen Lutheran Medical Foundation'}}}}