Ignite Creation Date:
2025-12-24 @ 3:25 PM
Ignite Modification Date:
2026-04-16 @ 6:33 PM
Study NCT ID:
NCT01116492
Status:
COMPLETED
Last Update Posted:
2010-05-21
First Post:
2010-05-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of the Inflammatory Reaction in Standard vs Single Port Cholecystectomy for Uncomplicated Cholelithiasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002769', 'term': 'Cholelithiasis'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, '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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-05', 'completionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-05-20', 'studyFirstSubmitDate': '2010-05-04', 'studyFirstSubmitQcDate': '2010-05-04', 'lastUpdatePostDateStruct': {'date': '2010-05-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-05-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['SILS', 'Inflammatory reaction', 'a-defensins', 'SILS vs standard laparoscopic cholecystectomy'], 'conditions': ['Cholelithiasis', 'Inflammatory Response']}, 'descriptionModule': {'briefSummary': 'This is a study of the inflammatory reaction in standard 4 port laparoscopic cholecystectomy vs Single Port Laparoscopic (SIL) cholecystectomy. It is assumed that the reduced trauma in SIL Cholecystectomy causes reduced inflammatory reaction compared to the 4 port laparoscopic cholecystectomy.', 'detailedDescription': 'Two groups of 20 patients each are included in this study. Pre operatively, 6 and 24 hours postoperatively, blood is taken from these patients, it is centrifuged and the plasma is taken. IL-6, a-defensins and CRP are measured for each sample.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Uncomplicated cholelithiasis\n* American Society of Anesthesiologists (ASA) I or II\n* No previous operations in upper abdomen\n* Body mass index (BMI) \\<30\n\nExclusion Criteria:\n\n* Cholecystitis\n* ASA \\> II\n* BMI\\>30\n* Previous operations in upper abdomen\n* Previous operations in intestine'}, 'identificationModule': {'nctId': 'NCT01116492', 'acronym': 'Lap vs SILS', 'briefTitle': 'Study of the Inflammatory Reaction in Standard vs Single Port Cholecystectomy for Uncomplicated Cholelithiasis', 'organization': {'class': 'OTHER', 'fullName': 'G. Hatzikosta General Hospital'}, 'officialTitle': 'Study of the Inflammatory Reaction in Standard vs Single Port Cholecystectomy for Uncomplicated Cholelithiasis', 'orgStudyIdInfo': {'id': 'GH-1948-05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Lap Group', 'description': 'Patients in this group are operated for uncomplicated cholelithiasis with standard 4 port laparoscopic cholecystectomy', 'interventionNames': ['Other: Laparoscopic cholecystectomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'SILS group', 'description': 'Patients in this group are operated for uncomplicated cholelithiasis with Single Incision Laparoscopic Cholecystectomy', 'interventionNames': ['Other: Single incision laparoscopic cholecystectomy']}], 'interventions': [{'name': 'Single incision laparoscopic cholecystectomy', 'type': 'OTHER', 'description': 'One port placed through the umbilicus', 'armGroupLabels': ['SILS group']}, {'name': 'Laparoscopic cholecystectomy', 'type': 'OTHER', 'description': 'Standard 4 port laparoscopic cholecystectomy', 'armGroupLabels': ['Lap Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45001', 'city': 'Ioannina', 'country': 'Greece', 'facility': '"G. Hatzikosta" General Hospital of Ioannina', 'geoPoint': {'lat': 39.66341, 'lon': 20.85187}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'G. Hatzikosta General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Konstantinos Tsimogiannis MD', 'oldOrganization': '"G. Hatzikosta" General Hospital of Ioannina'}}}}