Ignite Creation Date:
2025-12-24 @ 12:46 PM
Ignite Modification Date:
2026-02-24 @ 5:46 AM
Study NCT ID:
NCT03768661
Status:
COMPLETED
Last Update Posted:
2020-04-14
First Post:
2018-12-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Incisional Hernia Rate After Single-incision Laparoscopic Cholecystectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002769', 'term': 'Cholelithiasis'}, {'id': 'D000069290', 'term': 'Incisional Hernia'}], 'ancestors': [{'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}, '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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 185}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2017-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-13', 'studyFirstSubmitDate': '2018-12-03', 'studyFirstSubmitQcDate': '2018-12-06', 'lastUpdatePostDateStruct': {'date': '2020-04-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'incisional hernia rate', 'timeFrame': '5 years', 'description': 'Incisional Hernia by clinical examination or CT scan'}], 'secondaryOutcomes': [{'measure': 'operating time of the procedure', 'timeFrame': 'During the perioperative period', 'description': 'Total duration of the surgical procedure (in minutes)'}, {'measure': 'postoperative complications 1', 'timeFrame': 'Rate of participants suffering from biliary complication assesed after 30 days of follow-up', 'description': 'biliary leak or bile duct injury'}, {'measure': 'postoperative complications 2', 'timeFrame': 'Rate of participants who needed reoperation assesed after 30 days of follow-up', 'description': 'reoperations'}, {'measure': 'postoperative complications 3', 'timeFrame': 'Rate of participants suffering from seroma and/or wound infection assesed after 30 days of follow-up', 'description': 'surgical site occurrence'}, {'measure': 'cosmetic satisfaction', 'timeFrame': "patient's own cosmetic evaluation using a visual analogue score ranging from 0 to 10 (0=worst to 10=best) after 30 days of follow-up", 'description': "patient's cosmetic evaluation"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cholecystectomy', 'laparoscopy', 'single-incision laparoscopic surgery', 'incisional hernia', 'trocar-site hernia'], 'conditions': ['Cholelithiasis']}, 'referencesModule': {'references': [{'pmid': '20607556', 'type': 'BACKGROUND', 'citation': 'Antoniou SA, Pointner R, Granderath FA. Single-incision laparoscopic cholecystectomy: a systematic review. Surg Endosc. 2011 Feb;25(2):367-77. doi: 10.1007/s00464-010-1217-5. Epub 2010 Jul 7.'}, {'pmid': '28039641', 'type': 'BACKGROUND', 'citation': 'Evers L, Bouvy N, Branje D, Peeters A. Single-incision laparoscopic cholecystectomy versus conventional four-port laparoscopic cholecystectomy: a systematic review and meta-analysis. Surg Endosc. 2017 Sep;31(9):3437-3448. doi: 10.1007/s00464-016-5381-0. Epub 2016 Dec 30.'}, {'pmid': '24536008', 'type': 'BACKGROUND', 'citation': 'Jorgensen LN, Rosenberg J, Al-Tayar H, Assaadzadeh S, Helgstrand F, Bisgaard T. Randomized clinical trial of single- versus multi-incision laparoscopic cholecystectomy. Br J Surg. 2014 Mar;101(4):347-55. doi: 10.1002/bjs.9393.'}, {'pmid': '27778171', 'type': 'BACKGROUND', 'citation': 'Arezzo A, Passera R, Bullano A, Mintz Y, Kedar A, Boni L, Cassinotti E, Rosati R, Fumagalli Romario U, Sorrentino M, Brizzolari M, Di Lorenzo N, Gaspari AL, Andreone D, De Stefani E, Navarra G, Lazzara S, Degiuli M, Shishin K, Khatkov I, Kazakov I, Schrittwieser R, Carus T, Corradi A, Sitzman G, Lacy A, Uranues S, Szold A, Morino M. Multi-port versus single-port cholecystectomy: results of a multi-centre, randomised controlled trial (MUSIC trial). Surg Endosc. 2017 Jul;31(7):2872-2880. doi: 10.1007/s00464-016-5298-7. Epub 2016 Oct 24.'}, {'pmid': '31073959', 'type': 'DERIVED', 'citation': 'Hoyuela C, Juvany M, Guillaumes S, Ardid J, Trias M, Bachero I, Martrat A. Long-term incisional hernia rate after single-incision laparoscopic cholecystectomy is significantly higher than that after standard three-port laparoscopy: a cohort study. Hernia. 2019 Dec;23(6):1205-1213. doi: 10.1007/s10029-019-01969-x. Epub 2019 May 9.'}], 'seeAlsoLinks': [{'url': 'https://www.asahq.org/standards-and-guidelines/asa-physical-status-classification-system', 'label': 'American Society of Anesthesiologists. ASA Physical Status Classification System'}, {'url': 'http://www.cdc.gov/nhsn/PDFs/pscManual/9pscSSIcurrent.pdf', 'label': 'Centers for Disease Control and Prevention. National Healthcare Safety Network (NHSN) Procedure-Associated (PA) Module: Surgical Site Infection (SSI) Event'}]}, 'descriptionModule': {'briefSummary': 'Single-incision laparoscopic cholecystectomy (SILC) requires a larger incision than standard laparoscopy, which may increase the incidence of incisional hernias.\n\nThis study evaluated SILC and standard multiport cholecystectomy with respect to perioperative outcomes, hospital stay, cosmetic results, and postoperative complications, including the 5-years incisional hernia rate.', 'detailedDescription': 'A cohort study was performed for patients who underwent a laparoscopic cholecystectomy under an institutional review approved protocol. Between 2009 and 2011, 45 unselected patients underwent SILC performed by the same two surgeons.\n\nThe study inclusion criteria were the following: patients over 18 years with cholelithiasis, and candidates for elective surgery with no significant cardiopulmonary, hepatic or renal impairment (ASA score less than 4).\n\nThe exclusion criteria included the following: acute cholecystitis, associated CBD stones or pancreatitis, an emergency operation for complicated disease, mental illness, or patient refusal and/or absence of informed consent. All included patients signed a standard consent form after being informed about the characteristics of the SILC procedure.\n\nThe outcomes of these patients were compared with those of a control cohort series of 140 patients who underwent standard LC (with the same inclusion and exclusion criteria) during the same period.\n\nThe primary endpoint of the study was to determine the incisional hernia rate at the umbilical wound after 5 years of follow-up. Hernias were defined as evidence of a hernia at the clinical examination or those confirmed by ultrasound examination in case of clinical doubt.\n\nThe study secondary endpoints included the following: duration of surgery (from the start of the incision to skin closure), intraoperative and postoperative complications (30 days), hospital stay, and cosmetic satisfaction results (measured using a visual analogue scale score ranging from 0 to 10).\n\nThe following variables were also collected: age, gender, body mass index (BMI) and comorbidities. The anesthetic risk was measured according to the ASA classification system. Prolonged hospital stay (more than 24 h) and readmission (patients who returned for medical consultation before scheduled follow-up) were also recorded. All data were collected prospectively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '\\- patients over 18 years with cholelithiasis and candidates for elective surgery (cholecystectomy)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients over 18 years with cholelithiasis and candidates for elective surgery (cholecystectomy)\n* abscence of significant cardiopulmonary, hepatic or renal impairment (ASA score less than 4)\n\nExclusion Criteria:\n\n* acute cholecystitis\n* associated common bile duct stones or pancreatitis\n* emergency operation for complicated disease\n* ASA 4 (American Society of Anesthesiologists)\n* pregnancy\n* mental illness\n* patient refusal and/or absence of informed consent'}, 'identificationModule': {'nctId': 'NCT03768661', 'briefTitle': 'Incisional Hernia Rate After Single-incision Laparoscopic Cholecystectomy', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Plató'}, 'officialTitle': 'Long-term Incisional Hernia Rate After Single-Incision Laparoscopic Cholecystectomy (SILC) in Front of Standard Laparoscopy', 'orgStudyIdInfo': {'id': 'SILS Chole Hernia'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'SILC Group', 'description': 'patients with symptomatic cholelithiasis submitted to a single-incision laparoscopic cholecystectomy', 'interventionNames': ['Procedure: Single-incision Laparoscopic cholecystectomy']}, {'label': 'Laparoscopy Group', 'description': 'patients with symptomatic cholelithiasis submitted to a standard three trocar laparoscopic cholecystectomy', 'interventionNames': ['Procedure: Laparoscopic Cholecystectomy']}], 'interventions': [{'name': 'Single-incision Laparoscopic cholecystectomy', 'type': 'PROCEDURE', 'description': 'laparoscopic cholecystectomy performed through a single device located at a unique umbilical incision', 'armGroupLabels': ['SILC Group']}, {'name': 'Laparoscopic Cholecystectomy', 'type': 'PROCEDURE', 'description': 'laparoscopic cholecystectomy performed using three-trocars standard technique', 'armGroupLabels': ['Laparoscopy Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08006', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Plató', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'overallOfficials': [{'name': 'Carlos Hoyuela, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chief, Dept. of Surgery'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Plató', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}