Ignite Creation Date:
2025-12-24 @ 5:21 PM
Ignite Modification Date:
2025-12-27 @ 5:21 AM
Study NCT ID:
NCT00835250
Status:
COMPLETED
Last Update Posted:
2013-03-12
First Post:
2009-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Laparoscopic Cholecystectomy vs Hybrid Natural Orifice Translumenal Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002769', 'term': 'Cholelithiasis'}], 'ancestors': [{'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002763', 'term': 'Cholecystectomy'}], 'ancestors': [{'id': 'D001662', 'term': 'Biliary Tract Surgical Procedures'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-03-11', 'studyFirstSubmitDate': '2009-02-02', 'studyFirstSubmitQcDate': '2009-02-02', 'lastUpdatePostDateStruct': {'date': '2013-03-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-02-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Parietal complications after surgery (infection and hernia)', 'timeFrame': 'One year'}], 'secondaryOutcomes': [{'measure': "Surgical pain. General complications. Patient's preferences.", 'timeFrame': 'One year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Transvaginal cholecystectomy', 'NOTES', 'Minilaparoscopy', 'Endoscopic surgery', 'Cholecystectomy', 'Surgical translumenal endoscopic surgery', 'Transvaginal translumenal endoscopic surgery'], 'conditions': ['Cholelithiasis']}, 'referencesModule': {'references': [{'pmid': '18290693', 'type': 'RESULT', 'citation': 'Dolz C, Noguera JF, Martin A, Vilella A, Cuadrado A. [Transvaginal cholecystectomy (NOTES) combined with minilaparoscopy]. Rev Esp Enferm Dig. 2007 Dec;99(12):698-702. doi: 10.4321/s1130-01082007001200004. Spanish.'}, {'pmid': '22648123', 'type': 'DERIVED', 'citation': 'Noguera JF, Cuadrado A, Dolz C, Olea JM, Garcia JC. Prospective randomized clinical trial comparing laparoscopic cholecystectomy and hybrid natural orifice transluminal endoscopic surgery (NOTES) (NCT00835250). Surg Endosc. 2012 Dec;26(12):3435-41. doi: 10.1007/s00464-012-2359-4. Epub 2012 May 31.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine the feasibility of cholecystectomy made by a transvaginal approach with a NOTES procedure (natural orifice translumenal endoscopic surgery).', 'detailedDescription': 'Natural orifice transluminal endoscopic surgery (NOTES) makes it possible to perform intraperitoneal surgical procedures with a minimal number of access points in the abdominal wall. At the present time these procedures are hybrids. It is expected a better cosmetic result and lower incidence in parietal complications in front of laparoscopic cholecystectomy, but is necessary to investigate that these benefits should not be associated with complications of the new access to abdominal cavity.\n\nMethods. Prospective randomized clinical series of 60 female patients with gallstones that underwent endoscopic surgery, 20 of them operated with conventional laparoscopic approach, 20 by transumbilical endoscopic approach and 20 of them by transvaginal endoscopic approach. Variables as surgical wound infection, urinary tract infection, evisceration, hernia, mortality and other complications will be analyzed.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* age over 18 and under 65\n* symptomatic cholelithiasis with an indication for performing laparoscopic surgery\n* absence of any gynecological condition that could complicate the procedure (pelvic inflammatory disease or endometriosis)\n* perforated hymen\n* agreement on the patient's part not to use the vagina for two weeks after the surgery\n* signed specific informed consent upon providing specific information about the new surgical approach.\n\nExclusion Criteria:\n\n* age under 18 or over 65\n* unperforated hymen\n* presence of illness or condition with an increased risk of pelvic damage with transvaginal approach."}, 'identificationModule': {'nctId': 'NCT00835250', 'briefTitle': 'Laparoscopic Cholecystectomy vs Hybrid Natural Orifice Translumenal Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Son Llatzer'}, 'officialTitle': 'Prospective Randomized Clinical Trial Comparing Laparoscopic Cholecystectomy and Hybrid Natural Orifice Translumenal Endoscopic Surgery (NOTES)', 'orgStudyIdInfo': {'id': 'LLATZERNOTES-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Laparoscopy', 'description': 'Laparoscopic cholecystectomy', 'interventionNames': ['Procedure: Cholecystectomy']}, {'type': 'EXPERIMENTAL', 'label': 'Transumbilical', 'description': 'Transumbilical endoscopic cholecystectomy', 'interventionNames': ['Procedure: Cholecystectomy']}, {'type': 'EXPERIMENTAL', 'label': 'Transvaginal', 'description': 'Transvaginal endoscopic cholecystectomy', 'interventionNames': ['Procedure: Transvaginal hybrid NOTES cholecystectomy', 'Procedure: Cholecystectomy']}], 'interventions': [{'name': 'Transvaginal hybrid NOTES cholecystectomy', 'type': 'PROCEDURE', 'otherNames': ['NOTES cholecystectomy', 'Transvaginal cholecystectomy'], 'description': 'Cholecystectomy performed by using a combination of working tools inserted through the entry port for the minilaparoscopy and the videogastroscope, inserted into peritoneal cavity by transvaginal approach. The gallbladder is removed transvaginally through the videogastroscope.', 'armGroupLabels': ['Transvaginal']}, {'name': 'Cholecystectomy', 'type': 'PROCEDURE', 'description': 'Extirpation of the gallbladder by a surgical procedure', 'armGroupLabels': ['Laparoscopy', 'Transumbilical', 'Transvaginal']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07140', 'city': 'Palma de Mallorca', 'state': 'Balearic Islands', 'country': 'Spain', 'facility': 'Hospital Son Llàtzer', 'geoPoint': {'lat': 39.56939, 'lon': 2.65024}}], 'overallOfficials': [{'name': 'Angel Cuadrado, MD PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital Son Llàtzer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Son Llatzer', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief Department of Surgery', 'investigatorFullName': 'Jose F. Noguera', 'investigatorAffiliation': 'Hospital Son Llatzer'}}}}