Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2026-02-23 @ 1:12 AM
Study NCT ID:
NCT02142660
Status:
COMPLETED
Last Update Posted:
2014-12-31
First Post:
2012-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sprayshield as Adhesion Barrier System for Obese Patients
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-30', 'studyFirstSubmitDate': '2012-03-05', 'studyFirstSubmitQcDate': '2014-05-19', 'lastUpdatePostDateStruct': {'date': '2014-12-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-05-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'During the second surgical step the intensity of the adhesions in the operative field will be determined by the adhesion surface area and the adhesion intensity using', 'timeFrame': 'intra operative', 'description': 'During Conversion in Bypass or Sleeve Gastrectomy the intensity of the adhesions in the operative field will be determined by the adhesion surface area and the adhesion intensity using a 4-point : scale 0 (no adhesion), 1 (fine and esily detachable adhesions), 2 (thick vascularize adhesion), 3 (intense adhesion preventing the identification of cleavable plane between organs)'}], 'secondaryOutcomes': [{'measure': 'Duration of surgery', 'timeFrame': '30 day surgical mortility', 'description': 'Duration of surgery 30 day surgical mortility'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Adhesion barrier system', 'Bariatric surgery'], 'conditions': ['Severe Obesity']}, 'referencesModule': {'references': [{'pmid': '21468625', 'type': 'RESULT', 'citation': 'Nocca D, Guillaume F, Noel P, Picot MC, Aggarwal R, El Kamel M, Schaub R, de Seguin de Hons C, Renard E, Fabre JM. Impact of laparoscopic sleeve gastrectomy and laparoscopic gastric bypass on HbA1c blood level and pharmacological treatment of type 2 diabetes mellitus in severe or morbidly obese patients. Results of a multicenter prospective study at 1 year. Obes Surg. 2011 Jun;21(6):738-43. doi: 10.1007/s11695-011-0385-2.'}, {'pmid': '21298508', 'type': 'RESULT', 'citation': 'Fezzi M, Kolotkin RL, Nedelcu M, Jaussent A, Schaub R, Chauvet MA, Cassafieres C, Lefebvre P, Renard E, Bringer J, Fabre JM, Nocca D. Improvement in quality of life after laparoscopic sleeve gastrectomy. Obes Surg. 2011 Aug;21(8):1161-7. doi: 10.1007/s11695-011-0361-x.'}, {'pmid': '18340499', 'type': 'RESULT', 'citation': 'Blanc PM, Lagoutte JM, Picot MC, Deneve E, de Seguin C, Fabre JM, Nocca D. Preliminary results of the laparoscopic adjustable gastric banding procedure by a new generation of silicone band: MIDBAND. Obes Surg. 2008 May;18(5):569-72. doi: 10.1007/s11695-008-9441-y.'}, {'pmid': '18317859', 'type': 'RESULT', 'citation': 'Nocca D, Krawczykowsky D, Bomans B, Noel P, Picot MC, Blanc PM, de Seguin de Hons C, Millat B, Gagner M, Monnier L, Fabre JM. A prospective multicenter study of 163 sleeve gastrectomies: results at 1 and 2 years. Obes Surg. 2008 May;18(5):560-5. doi: 10.1007/s11695-007-9288-7.'}, {'pmid': '17103270', 'type': 'RESULT', 'citation': 'Nocca D, Aggarwal R, Blanc P, Gallix B, Di Mauro GL, Millat B, Seguin des De Hons C, Deneve E, Rodier JG, Tincani G, Pierredon MA, Fabre JM. Laparoscopic vertical banded gastroplasty. A multicenter prospective study of 200 procedures. Surg Endosc. 2007 Jun;21(6):870-4. doi: 10.1007/s00464-006-9048-0. Epub 2006 Nov 14.'}]}, 'descriptionModule': {'briefSummary': 'The application of SprayShield during a laparoscopic band removal (first surgical step) will be evaluated to see if the postoperative adhesions between the stomach, the left liver and the diaphragm are not severe, facilitating the surgical surgical step of a gastric bypass or a sleeve gastrectomy.', 'detailedDescription': 'Monocenter and observational study on 20 obese patients, requiring removal of the gastric band for poor results (weight regain or insufficient weight-loss) or mechanical complications of the band ( slippage, esophageal dilation) and schedule for a second step surgery of gastric bypass or sleeve gastrectomy 2 months later.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Obese male or female who would benefit from a gastric band removal and for whom a second surgical step with conversion to sleeve gastrectomy or bypass is scheduled', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Obese male or female who would benefit from a gastric band removal and for whom a second surgical step with conversion to sleeve gastrectomy or bypass is scheduled\n\nExclusion Criteria:\n\n* The patients having an ablation of ring motivated for an infectious complication'}, 'identificationModule': {'nctId': 'NCT02142660', 'acronym': 'Sprayshield', 'briefTitle': 'Sprayshield as Adhesion Barrier System for Obese Patients', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Prospective Study Evaluating the Usefulness of Sprayshield as Adhesion Barrier System in Two Steps Laparoscopic Bariatric Surgery for Obese Patients', 'orgStudyIdInfo': {'id': 'UF8744'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Sprayshield', 'description': 'Applied to the operating zone during an ablation of gastric died ring at obese patients programmed for the second bariatric surgery to type of bypass gastric or of gastrectomie', 'interventionNames': ['Procedure: ablation of gastric']}], 'interventions': [{'name': 'ablation of gastric', 'type': 'PROCEDURE', 'description': 'Applied to the operating zone during an ablation of gastric died ring at obese patients programmed for the second bariatric surgery to type of bypass gastric or of gastrectomie in wing', 'armGroupLabels': ['Sprayshield']}]}, 'contactsLocationsModule': {'locations': [{'zip': '342950', 'city': 'Montpellier', 'country': 'France', 'facility': 'Department of Digestive Surgery A, Saint Eloi Hospital', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'overallOfficials': [{'name': 'Jean Michel FABRE', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Montpellier'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}