Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT01348620
Status:
UNKNOWN
Last Update Posted:
2011-05-05
First Post:
2011-04-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Single Port Laparoscopic Cholecystectomy Versus Four Port Laparoscopic Cholecystectomy: Impact on Postoperative Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 58}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-05', 'lastUpdateSubmitDate': '2011-05-04', 'studyFirstSubmitDate': '2011-04-26', 'studyFirstSubmitQcDate': '2011-05-04', 'lastUpdatePostDateStruct': {'date': '2011-05-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-05-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post-operative pain scores (visual analogue pain scale from 0-10)', 'timeFrame': 'Before surgery (baseline) and 2 hrs, 4 hrs, 6hrs, 12hrs, 24hrs and 48hrs after surgery'}], 'secondaryOutcomes': [{'measure': 'Patient-assessed cosmesis on the Visual Analogue Scale', 'timeFrame': '30 days after surgery'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['single port cholecystectomy'], 'conditions': ['Postoperative Pain']}, 'referencesModule': {'references': [{'pmid': '18982149', 'type': 'BACKGROUND', 'citation': 'Rao PP, Bhagwat SM, Rane A, Rao PP. The feasibility of single port laparoscopic cholecystectomy: a pilot study of 20 cases. HPB (Oxford). 2008;10(5):336-40. doi: 10.1080/13651820802276622.'}, {'pmid': '20066749', 'type': 'BACKGROUND', 'citation': 'Hirano Y, Watanabe T, Uchida T, Yoshida S, Tawaraya K, Kato H, Hosokawa O. Single-incision laparoscopic cholecystectomy: single institution experience and literature review. World J Gastroenterol. 2010 Jan 14;16(2):270-4. doi: 10.3748/wjg.v16.i2.270.'}, {'pmid': '18815836', 'type': 'BACKGROUND', 'citation': 'Tacchino R, Greco F, Matera D. Single-incision laparoscopic cholecystectomy: surgery without a visible scar. Surg Endosc. 2009 Apr;23(4):896-9. doi: 10.1007/s00464-008-0147-y. Epub 2008 Sep 25.'}, {'pmid': '18709515', 'type': 'BACKGROUND', 'citation': 'Gumbs AA, Milone L, Sinha P, Bessler M. Totally transumbilical laparoscopic cholecystectomy. J Gastrointest Surg. 2009 Mar;13(3):533-4. doi: 10.1007/s11605-008-0614-8.'}, {'pmid': '19630589', 'type': 'BACKGROUND', 'citation': 'Kuon Lee S, You YK, Park JH, Kim HJ, Lee KK, Kim DG. Single-port transumbilical laparoscopic cholecystectomy: a preliminary study in 37 patients with gallbladder disease. J Laparoendosc Adv Surg Tech A. 2009 Aug;19(4):495-9. doi: 10.1089/lap.2008.0424.'}, {'pmid': '26036221', 'type': 'DERIVED', 'citation': 'Partelli S, Barugola G, Sartori A, Crippa S, Falconi M, Ruffo G. Single-incision laparoscopic cholecystectomy versus traditional laparoscopic cholecystectomy performed by a single surgeon: findings of a randomized trial. Surg Today. 2016 Mar;46(3):313-8. doi: 10.1007/s00595-015-1182-7. Epub 2015 Jun 3.'}, {'pmid': '21910897', 'type': 'DERIVED', 'citation': 'Steinemann DC, Raptis DA, Lurje G, Oberkofler CE, Wyss R, Zehnder A, Lesurtel M, Vonlanthen R, Clavien PA, Breitenstein S. Cosmesis and body image after single-port laparoscopic or conventional laparoscopic cholecystectomy: a multicenter double blinded randomised controlled trial (SPOCC-trial). BMC Surg. 2011 Sep 12;11:24. doi: 10.1186/1471-2482-11-24.'}]}, 'descriptionModule': {'briefSummary': 'This is a single-institution, prospective, randomized controlled trial. Subjects determined to need a cholecystectomy will be consented for surgery and study participation prior to enrollment in this study. Patients will then be randomized to receive either a single port laparoscopic cholecystectomy or a four port laparoscopic cholecystectomy.', 'detailedDescription': 'The main advantages of laparoscopic surgery are reduced postoperative pain, shorter hospital stay and the cosmetic result. Although reduced, however, pain is still substantial and constitutes the main clinical problem after laparoscopic cholecystectomy, in particular for future daily planned procedures.\n\nRecently, a new technique of laparoscopic cholecystectomy has been developed, in which all instruments are inserted through the same port placed in the umbilical incision. This technique for cholecystectomy has been proved to be feasible and safe by several studies.\n\nThe purpose of the study is to compare postoperative pain, operating time, cosmetic result, between one port and standard laparoscopic cholecystectomy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Biliary cholic\n* Biliary dyskinesia\n* Gallbladder polyps\n* Other diagnosis at the discretion of the surgeon\n\nExclusion Criteria:\n\n* History of Acute cholecystitis\n* Jaundice\n* Choledocolithiasis\n* History of Pancreatitis\n* Severe comorbidity\n* BMI \\> 30'}, 'identificationModule': {'nctId': 'NCT01348620', 'briefTitle': 'Single Port Laparoscopic Cholecystectomy Versus Four Port Laparoscopic Cholecystectomy: Impact on Postoperative Pain', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS Sacro Cuore Don Calabria di Negrar'}, 'orgStudyIdInfo': {'id': 'MNT-2011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single port laparoscopic device', 'interventionNames': ['Device: Single port laparoscopic cholecystectomy SINGLE SITE LAPAROSCOPY ACCESS SYSTEM (Johnson & Johnson Medical Spa)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Four-port laparoscopic device', 'interventionNames': ['Procedure: Four port laparoscopic cholecystectomy surgery']}], 'interventions': [{'name': 'Single port laparoscopic cholecystectomy SINGLE SITE LAPAROSCOPY ACCESS SYSTEM (Johnson & Johnson Medical Spa)', 'type': 'DEVICE', 'otherNames': ['One-trocar cholecistectomy'], 'description': 'Single port laparoscopic cholecystectomy. SINGLE SITE LAPAROSCOPY ACCESS SYSTEM (Johnson \\& Johnson Medical Spa)', 'armGroupLabels': ['Single port laparoscopic device']}, {'name': 'Four port laparoscopic cholecystectomy surgery', 'type': 'PROCEDURE', 'otherNames': ['traditional Laparoscopic cholecistectomy'], 'description': 'Four port laparoscopic cholecystectomy surgery', 'armGroupLabels': ['Four-port laparoscopic device']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37024', 'city': 'Negrar', 'state': 'Verona', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giuliano Barugola, MD', 'role': 'CONTACT', 'email': 'barugolagiuliano@hotmail.com'}, {'name': 'Giacomo Ruffo, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Giuliano Barugola, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Alberto Sartori, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Stefano crippa, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Stefano Partelli, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Sacro Cuore - Don Calabria Hospital', 'geoPoint': {'lat': 45.52918, 'lon': 10.93899}}], 'centralContacts': [{'name': 'Giuliano Barugola, MD', 'role': 'CONTACT', 'email': 'barugolagiuliano@hotmail.com', 'phone': '00390456013111'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS Sacro Cuore Don Calabria di Negrar', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dr Perantoni Laura', 'oldOrganization': 'Sacro Cuore Don Calabria General Hospital'}}}}