Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2026-02-22 @ 6:45 PM
Study NCT ID:
NCT01513005
Status:
COMPLETED
Last Update Posted:
2025-09-19
First Post:
2012-01-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility of Laparoscopic Sleeve Gastrectomy in Day Case Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-16', 'studyFirstSubmitDate': '2012-01-16', 'studyFirstSubmitQcDate': '2012-01-19', 'lastUpdatePostDateStruct': {'date': '2025-09-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'unexpected admission rate', 'timeFrame': 'the day following the surgery', 'description': 'the unexpected admission rate corresponds to the number of overnight hospitalization i.e. the number of patients not treated considering a Day-Case Surgery.'}], 'secondaryOutcomes': [{'measure': 'readmission rate', 'timeFrame': 'one year', 'description': 'the readmission rate is defined as the number of readmission with conventional hospitalization'}, {'measure': 'unexpected consultation rate', 'timeFrame': 'one year', 'description': 'the unexpected consultation rate corresponds to the number of consultations after the Laparoscopic Sleeve Gastrectomy because of a postoperative outcome (adverse event, pain...)'}, {'measure': 'reoperation rate', 'timeFrame': 'one year'}, {'measure': 'overall length of stay', 'timeFrame': 'one year', 'description': 'the overall length of stay corresponds to the duration of all hospitalizations i.e. between the surgical procedure and the end of follow up.'}, {'measure': 'per operative outcomes', 'timeFrame': 'one year', 'description': 'the per operative outcomes include each event observed during the surgical procedure'}, {'measure': 'postoperative outcomes', 'timeFrame': 'one year', 'description': 'the postoperative outcomes include all outcomes reported during the follow-up period'}, {'measure': 'efficiency of Laparoscopic Sleeve Gastrectomy', 'timeFrame': 'six months', 'description': 'the efficiency of Laparoscopic Sleeve Gastrectomy is evaluated with the BAROS questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Laparoscopic Sleeve Gastrectomy', 'obesity management'], 'conditions': ['Obesity']}, 'referencesModule': {'references': [{'pmid': '21769286', 'type': 'BACKGROUND', 'citation': 'Pequignot A, Dhahria A, Mensah E, Verhaeghe P, Badaoui R, Sabbagh C, Regimbeau JM. Stapling and Section of the Nasogastric Tube during Sleeve Gastrectomy: How to Prevent and Recover? Case Rep Gastroenterol. 2011;5(2):350-4. doi: 10.1159/000329706. Epub 2011 Jul 6.'}, {'pmid': '20971049', 'type': 'BACKGROUND', 'citation': 'Dhahri A, Verhaeghe P, Hajji H, Fuks D, Badaoui R, Deguines JB, Regimbeau JM. Sleeve gastrectomy: technique and results. J Visc Surg. 2010 Oct;147(5 Suppl):e39-46. doi: 10.1016/j.jviscsurg.2010.08.016. No abstract available.'}, {'pmid': '19902316', 'type': 'BACKGROUND', 'citation': 'Sabbagh C, Verhaeghe P, Dhahri A, Brehant O, Fuks D, Badaoui R, Regimbeau JM. Two-year results on morbidity, weight loss and quality of life of sleeve gastrectomy as first procedure, sleeve gastrectomy after failure of gastric banding and gastric banding. Obes Surg. 2010 Jun;20(6):679-84. doi: 10.1007/s11695-009-0007-4. Epub 2009 Nov 10.'}, {'pmid': '19081482', 'type': 'BACKGROUND', 'citation': 'Fuks D, Verhaeghe P, Brehant O, Sabbagh C, Dumont F, Riboulot M, Delcenserie R, Regimbeau JM. Results of laparoscopic sleeve gastrectomy: a prospective study in 135 patients with morbid obesity. Surgery. 2009 Jan;145(1):106-13. doi: 10.1016/j.surg.2008.07.013. Epub 2008 Sep 30.'}, {'pmid': '18696169', 'type': 'BACKGROUND', 'citation': 'Fuks D, Dumont F, Berna P, Verhaeghe P, Sinna R, Sabbagh C, Demuynck F, Yzet T, Delcenserie R, Bartoli E, Regimbeau JM. Case report-complex management of a postoperative bronchogastric fistula after laparoscopic sleeve gastrectomy. Obes Surg. 2009 Feb;19(2):261-264. doi: 10.1007/s11695-008-9643-3. Epub 2008 Aug 12.'}, {'pmid': '27687352', 'type': 'RESULT', 'citation': 'Badaoui R, Alami Chentoufi Y, Hchikat A, Rebibo L, Popov I, Dhahri A, Antoun G, Regimbeau JM, Lorne E, Dupont H. Outpatient laparoscopic sleeve gastrectomy: first 100 cases. J Clin Anesth. 2016 Nov;34:85-90. doi: 10.1016/j.jclinane.2016.03.026. Epub 2016 May 3.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to determinate the feasibility of the Laparoscopic Sleeve Gastrectomy, a bariatric surgery i.e. a surgery as a treatment for obesity, could be proposed as a Day-Case surgery.', 'detailedDescription': 'The purpose of this study is to investigate whether the patients with morbid obesity requiring a surgical approach by Laparoscopic Sleeve Gastrectomy could be operated according to a "day-case surgery" modality.\n\nThe sequence of this study is the following:\n\n1. patients consultation for bariatric management: during this consultation, the investigator is looking for exclusion criteria and prescribes laboratory tests.\n2. medical records of each patient are reviewed by an obesity-related staff: Laparoscopic Sleeve Gastrectomy is proposed.\n3. during a second consultation, the surgeon informed the patient about the proposition of the staff and his potential inclusion in this study\n4. after obtained his consent, the surgical procedure is planned and Laparoscopic Sleeve Gastrectomy is done in the Day-Case Surgery Unit.\n5. the following day the surgery, a nurse calls the patient to identify a potential postoperative outcome (nausea, vomiting, uncontrolled pain...)\n6. the 8th postoperative day, a consultation is done with laboratory tests and dietary follow-up.\n7. follow-up consultations are scheduled at 3, 6 and 12 months to evaluate the efficiency of the surgery procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* sufficient understanding\n* good observance of medical prescription\n* availability of a responsible adult for the first operative night\n* patients living nearby the hospital (1 h maximum away)\n* telephonic accessibility\n* between 18 and 60 years old adults\n* body mass index less than 60 kg/m2\n* obesity requiring bariatric surgery\n* surgery validated by an obesity-related staff\n\nExclusion Criteria:\n\n* patient under administrative or legal protection\n* obesity without HAS criteria\n* cardiovascular comorbidity\n* pulmonary comorbidity\n* curative anticoagulant therapy\n* bad diabetes control\n* body mass index higher than 60 kg/m2'}, 'identificationModule': {'nctId': 'NCT01513005', 'acronym': 'GASTRAMBU', 'briefTitle': 'Feasibility of Laparoscopic Sleeve Gastrectomy in Day Case Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire, Amiens'}, 'officialTitle': 'Feasibility of Day Case Management by Laparoscopic Sleeve Gastrectomy for Obesity: a Pilot Study', 'orgStudyIdInfo': {'id': 'PI10-PR.-REGIMBEAU'}, 'secondaryIdInfos': [{'id': '2010-A01178-31', 'type': 'OTHER', 'domain': 'ID-RCB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Laparoscopic Sleeve Gastrectomy', 'interventionNames': ['Procedure: Laparoscopic Sleeve Gastrectomy']}], 'interventions': [{'name': 'Laparoscopic Sleeve Gastrectomy', 'type': 'PROCEDURE', 'description': 'the operative technique consists in few steps:\n\n* position of 4 trocars and insertion of a nasogastric tube\n* dissection and mobilization of the greater curvature of the stomach\n* preparation of the stomach for division\n* gastric partition\n* extraction of the gastric remnant\n* postoperative surveillance', 'armGroupLabels': ['Laparoscopic Sleeve Gastrectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80054', 'city': 'Amiens', 'country': 'France', 'facility': 'North Universitary Hospital', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}], 'overallOfficials': [{'name': 'Jean-Marc REGIMBEAU, MD,phD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Amiens'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire, Amiens', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}