Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2026-01-07 @ 12:55 AM
Study NCT ID:
NCT02023294
Status:
COMPLETED
Last Update Posted:
2013-12-30
First Post:
2013-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Conventional Laparoscopic Sleeve Gastrectomy Versus Endograb-assisted Single-port Sleeve Gastrectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009767', 'term': 'Obesity, Morbid'}], 'ancestors': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-23', 'studyFirstSubmitDate': '2013-12-10', 'studyFirstSubmitQcDate': '2013-12-23', 'lastUpdatePostDateStruct': {'date': '2013-12-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Perioperative complications', 'timeFrame': '1 month', 'description': 'Appearence of intraoperative and postoperative complications derived from the technique will be recorded an compared with the two techniques.'}], 'primaryOutcomes': [{'measure': 'Postoperative Pain', 'timeFrame': '3 days', 'description': 'Postoperative pain is assessed using a visual analog scale (VAS)on the first 3 postoperative days'}], 'secondaryOutcomes': [{'measure': 'Cosmestic results', 'timeFrame': '1,3 and 6 months', 'description': 'Cosmetic results will be assess using visual analog scale (VAS)at 1,3 and 6 months after surgery'}, {'measure': 'Operative time', 'timeFrame': 'Surgery', 'description': 'operative time will be compared between two thechniques'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Morbid Obesity']}, 'referencesModule': {'references': [{'pmid': '19880099', 'type': 'BACKGROUND', 'citation': 'Morales-Conde S, Garcia Moreno J, Canete Gomez J, Barranco Moreno A, Socas Macias M. [Single incision laparoscopic right hemicolectomy due to cancer of the colon]. Cir Esp. 2010 Aug;88(2):129-31. doi: 10.1016/j.ciresp.2009.07.016. Epub 2009 Oct 31. No abstract available. Spanish.'}, {'pmid': '17593452', 'type': 'BACKGROUND', 'citation': 'Martin-Cartes J, Morales-Conde S, Suarez-Grau J, Lopez-Bernal F, Bustos-Jimenez M, Cadet-Dussort H, Socas-Macias M, Alamo-Martinez J, Tutosaus-Gomez JD, Morales-Mendez S. Use of hyaluronidase cream to prevent peritoneal adhesions in laparoscopic ventral hernia repair by means of intraperitoneal mesh fixation using spiral tacks. Surg Endosc. 2008 Mar;22(3):631-4. doi: 10.1007/s00464-007-9423-5.'}, {'pmid': '11965467', 'type': 'BACKGROUND', 'citation': "Feliu-Pala X, Martin-Gomez M, Morales-Conde S, Fernandez-Sallent E. The impact of the surgeon's experience on the results of laparoscopic hernia repair. Surg Endosc. 2001 Dec;15(12):1467-70. doi: 10.1007/s00464-001-9017-6."}]}, 'descriptionModule': {'briefSummary': 'Bariatric surgery has been established as the best treatment for morbid obesity, compared with diet or medical treatment. Laparoscopic approach have improved the results of this surgery in terms of postoperative pain, reduction in the number of complications and hospital stay, as well as better cosmetic results. Conventional laparoscopic technique requires five to seven abdominal incisions to facilitate placement of the multiple trocars. New Single Incision Laparoscopic Surgery (SILS)has been developed as a new technique where only one incision is needed for the introduction of all trocars. Altough this technique can be performed with conventional laparoscopic instruments, new devides have been developed for facilitate this operations by SILS. The investigators think that reducing the number of incision would decrease the postoperative pain and improve cosmetic results in our patients, being a safe and technically feasible intervention supported by these special devices.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body Mass Index \\> 40\n* Body Mass Index \\> 35 with 2 mayor comorbidities\n\nExclusion Criteria:\n\n* Severe gastroesophageal reflux\n* Esophagitis grade B or higher\n* Midline periumbilical incision\n* Umbilical hernia \\>4cms.'}, 'identificationModule': {'nctId': 'NCT02023294', 'acronym': 'GTLEND', 'briefTitle': 'Conventional Laparoscopic Sleeve Gastrectomy Versus Endograb-assisted Single-port Sleeve Gastrectomy', 'organization': {'class': 'OTHER', 'fullName': 'Hospitales Universitarios Virgen del Rocío'}, 'officialTitle': 'Prospective Randomized Clinical Trial Comparing COnventional Laparoscopic Sleeve Gastrectomy Versus Endograb-assisted Single-port Sleeve Gastrectomy', 'orgStudyIdInfo': {'id': 'GTL-EG-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Lap', 'description': 'Patients candidate to bariatric surgery undergoing Conventional laparoscopic Sleeve Gastrectomy', 'interventionNames': ['Procedure: Convetional laparoscopic Sleeve Gastrectomy']}, {'type': 'EXPERIMENTAL', 'label': 'SILS', 'description': 'Patients candidate to bariatric surgery undergoing Single Incision Laparoscopic Sleeve Gastrectomy supported by Endograb', 'interventionNames': ['Procedure: SILS Sleeve gastrectomy']}], 'interventions': [{'name': 'Convetional laparoscopic Sleeve Gastrectomy', 'type': 'PROCEDURE', 'description': 'Convetional laparoscopic sleeve gastrectomy using 5 ports (incisions) in the abdominal wall', 'armGroupLabels': ['Lap']}, {'name': 'SILS Sleeve gastrectomy', 'type': 'PROCEDURE', 'otherNames': ['Endograb™ (Virtual Ports, Misgav, Israel)'], 'description': 'Single incision Sleeve gastrectomy using only one port (incision) on the abdominal wall assisted by an special Traction Device for single port surgery (Endograb)', 'armGroupLabels': ['SILS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41013', 'city': 'Seville', 'state': 'Seville', 'country': 'Spain', 'facility': 'Hospital Universitario Virgen del Rocio', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}], 'overallOfficials': [{'name': 'Morales Conde Salvador, phD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitario Virgen del Rocio'}, {'name': 'Alarcón del Agua Isaías, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital Universitario Virgen del Rocio'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospitales Universitarios Virgen del Rocío', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Innovation and Minimally Invasive Surgery Unit Cordinator', 'investigatorFullName': 'Salvador Morales Conde', 'investigatorAffiliation': 'Hospitales Universitarios Virgen del Rocío'}}}}