Ignite Creation Date:
2025-12-24 @ 6:35 PM
Ignite Modification Date:
2025-12-31 @ 8:27 AM
Study NCT ID:
NCT02417857
Status:
COMPLETED
Last Update Posted:
2015-04-16
First Post:
2015-04-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Single İncision Laparoscopic Cholecystectomy Versus Laparoscopic Cholecystectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D017081', 'term': 'Cholecystectomy, Laparoscopic'}, {'id': 'D003226', 'term': 'Congresses as Topic'}], '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'}, {'id': 'D009938', 'term': 'Organizations'}, {'id': 'D004472', 'term': 'Health Care Economics and Organizations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-15', 'studyFirstSubmitDate': '2015-04-08', 'studyFirstSubmitQcDate': '2015-04-15', 'lastUpdatePostDateStruct': {'date': '2015-04-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-04-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of life measure', 'timeFrame': 'We had performed the questionnaire at postoperative 6 th month'}], 'secondaryOutcomes': [{'measure': 'Body Image Questionnaire measure', 'timeFrame': 'We had performed the questionnaire at postoperative 6 th month'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Single İncision Laparoscopic Surgery', 'Conventional Laparoscopic Surgery'], 'conditions': ['Laparoscopic Surgical Procedures']}, 'referencesModule': {'references': [{'pmid': '23269370', 'type': 'RESULT', 'citation': 'Abd Ellatif ME, Askar WA, Abbas AE, Noaman N, Negm A, El-Morsy G, El Nakeeb A, Magdy A, Amin M. Quality-of-life measures after single-access versus conventional laparoscopic cholecystectomy: a prospective randomized study. Surg Endosc. 2013 Jun;27(6):1896-906. doi: 10.1007/s00464-012-2625-5. Epub 2012 Dec 27.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to compare outcomes of quality-of-life measures and evaluate the body image and cosmesis between Single Incision Laparoscopic Cholecystectomy (SILC) and Conventional Laparoscopic Cholecystectomy (CLC).Twenty eight patients underwent SILC and 30 underwent LC.Fifty-eight patients were included the study and divided into two groups. The results of the questionnaires were statistically compared.', 'detailedDescription': 'Recently, single incision laparoscopic cholecystectomy (SILC) is one of the minimally invasive technique, developed to reduce the need of multiple ports and has become popular among the surgeons. This study was conducted with fifty eight patients between January 2011 and March 2013 in Turkey. Fifty-eight patients were included the study and divided into two groups. Quality-of-life measures was evaluated by the EuroQol EQ-5D questionnaire.Cosmesis and body image were evaluated with the Body Image Questionnaire. All statistical analyses were performed by IBM Statistics 21.0 and MS-Excel 2007. A value of p\\<0.05 was accepted as statistically significant.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patients who were scheduled for elective cholecystectomy were included in the study\n\nExclusion Criteria:\n\n* pregnancy\n* acute cholecystitis\n* ASA 3-4 (American Society of Anesthesiologists)\n* history of bile duct stone migration\n* biller pancreatitis\n* upper laparatomy\n* any ventral hernia repair\n* chronic systemic disease or\n* with allergic attitude to any agent'}, 'identificationModule': {'nctId': 'NCT02417857', 'briefTitle': 'Comparison of Single İncision Laparoscopic Cholecystectomy Versus Laparoscopic Cholecystectomy', 'organization': {'class': 'OTHER', 'fullName': 'Ankara Mevki Military Hospital'}, 'officialTitle': 'Quality-of-life, Body Image and Cosmesis After Single Incision Laparoscopic Cholecystectomy (SILC) Versus Conventional Laparoscopic Cholecystectomy (CLC)', 'orgStudyIdInfo': {'id': 'GMMA-LEC-1648.4-70'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Laparoscopic Cholecystectomy (SILC)', 'description': 'Group 1: Single Incision Laparoscopic Cholecystectomy (Intervention)', 'interventionNames': ['Procedure: Laparoscopic Cholecystectomy (Single Incision)']}, {'type': 'EXPERIMENTAL', 'label': 'Laparoscopic Cholecystectomy (CLC)', 'description': 'Group 2: Conventional Laparoscopic Cholecystectomy (Intervention)', 'interventionNames': ['Procedure: Laparoscopic Cholecystectomy (Conventional)']}], 'interventions': [{'name': 'Laparoscopic Cholecystectomy (Single Incision)', 'type': 'PROCEDURE', 'description': 'We performed Single Incision Laparoscopic Cholecystectomy (SILC) operation to the group-1', 'armGroupLabels': ['Laparoscopic Cholecystectomy (SILC)']}, {'name': 'Laparoscopic Cholecystectomy (Conventional)', 'type': 'PROCEDURE', 'description': 'We performed Conventional Laparoscopic Cholecystectomy (CLC) to group-2', 'armGroupLabels': ['Laparoscopic Cholecystectomy (CLC)']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Huseyin SINAN, Prof. M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'VAN MILITARY HOSPITAL, GENERAL SURGERY DEPARTMENT, VAN, TURKEY'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara Mevki Military Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'General Surgeon (M.D.)', 'investigatorFullName': 'MD. Mehmet SAYDAM (General Surgeon)', 'investigatorAffiliation': 'Ankara Mevki Military Hospital'}}}}