Nctid:
NCT06222177
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000005764", "term"=>"Gastroesophageal Reflux"}], "ancestors"=>[{"id"=>"D000015154", "term"=>"Esophageal Motility Disorders"}, {"id"=>"D000003680", "term"=>"Deglutition Disorders"}, {"id"=>"D000004935", "term"=>"Esophageal Diseases"}, {"id"=>"D000005767", "term"=>"Gastrointestinal Diseases"}, {"id"=>"D000004066", "term"=>"Digestive System Diseases"}], "browseLeaves"=>[{"id"=>"M12701", "name"=>"Obesity", "relevance"=>"LOW"}, {"id"=>"M8880", "name"=>"Gastroesophageal Reflux", "asFound"=>"Gastro Esophageal Reflux", "relevance"=>"HIGH"}, {"id"=>"M17874", "name"=>"Esophageal Motility Disorders", "relevance"=>"LOW"}, {"id"=>"M17875", "name"=>"Esophageal Spasm, Diffuse", "relevance"=>"LOW"}, {"id"=>"M6882", "name"=>"Deglutition Disorders", "relevance"=>"LOW"}, {"id"=>"M8085", "name"=>"Esophageal Diseases", "relevance"=>"LOW"}, {"id"=>"M8883", "name"=>"Gastrointestinal Diseases", "relevance"=>"LOW"}, {"id"=>"M7255", "name"=>"Digestive System Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Nutritional and Metabolic Diseases", "abbrev"=>"BC18"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Digestive System Diseases", "abbrev"=>"BC06"}, {"name"=>"Ear, Nose, and Throat Diseases", "abbrev"=>"BC09"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"RETROSPECTIVE", "observationalModel"=>"COHORT"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>150}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2024-01-01", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2024-06-01", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-01-26", "studyFirstSubmitDate"=>"2024-01-15", "studyFirstSubmitQcDate"=>"2024-01-15", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-30", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-24", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-04-01", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Acid exposure time", "timeFrame"=>"January-March 2024"}]}, "oversightModule"=>{"isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Gastro Esophageal Reflux"]}, "referencesModule"=>{"references"=>[{"pmid"=>"37466827", "type"=>"RESULT", "citation"=>"Bonaldi M, Rubicondo C, Andreasi V, Giorgi R, Cesana G, Ciccarese F, Uccelli M, Zanoni A, Villa R, De Carli S, Oldani A, Dokic D, Olmi S. Role of Preoperative High-Resolution Manometry in the Identification of Patients at High Risk of Postoperative GERD Symptoms 1 Year After Sleeve Gastrectomy. Obes Surg. 2023 Sep;33(9):2749-2757. doi: 10.1007/s11695-023-06732-x. Epub 2023 Jul 19."}, {"pmid"=>"37935430", "type"=>"RESULT", "citation"=>"Memon MA, Osland E, Yunus RM, Alam K, Hoque Z, Khan S. Gastroesophageal reflux disease following laparoscopic vertical sleeve gastrectomy and laparoscopic roux-en-Y gastric bypass: meta-analysis and systematic review of 5-year data. Dis Esophagus. 2024 Feb 29;37(3):doad063. doi: 10.1093/dote/doad063."}, {"pmid"=>"36270615", "type"=>"RESULT", "citation"=>"Siboni S, Kristo I, Rogers BD, De Bortoli N, Hobson A, Louie B, Lee YY, Tee V, Tolone S, Marabotto E, Visaggi P, Haworth J, Ivy M, Greenan G, Facchini C, Masuda T, Yano F, Perry K, Balasubramanian G, Theodorou D, Triantafyllou T, Cusmai L, Boveri S, Schoppmann SF, Gyawali CP, Bonavina L. Improving the Diagnostic Yield of High-Resolution Esophageal Manometry for GERD: The \"Straight Leg-Raise\" International Study. Clin Gastroenterol Hepatol. 2023 Jul;21(7):1761-1770.e1. doi: 10.1016/j.cgh.2022.10.008. Epub 2022 Oct 19."}]}, "descriptionModule"=>{"briefSummary"=>"There is an increasing interest in High resolution manometry (HRM) in the preoperative assessment of patients with obesity, in order to identify the best surgical option. Sleeve gastrectomy (SG) has been known to increase the risk of gastro-esophageal reflux disease (GERD). Different techniques have been recently developed and validated to offer to these patients protection against pathologic GERD after SG.\n\nA recent study found a significant correlation between straight leg raise (SLR) maneuver during HRM and a positive pH-study. However, these maneuver has not been validated in an obese population, therefore the normality cut-off remain unknown.\n\nA multicenter study with a large number of patients undergoing pre-operative assessment for bariatric surgery could provide a precise threshold to predict pathologic esophageal acid exposure time."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"75 years", "minimumAge"=>"18 years", "samplingMethod"=>"PROBABILITY_SAMPLE", "studyPopulation"=>"Obese patients with thorough pathophysiologic evaluation with or without suspect of GERD", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Complete and adequate HRM and pH-impedance study performed within 2 weeks\n* Successfully performed SLR maneuver (adequate intra-abdominal pressure augmentation)\n* Obese with BMI\\>35 Kg/m2\n\nExclusion Criteria:\n\n* Patients under the age of 18\n* Patients with prior foregut surgery\n* Paraesophageal hiatal hernia\n* Scleroderma\n* Eosinophilic esophagitis\n* Pregnancy"}, "identificationModule"=>{"nctId"=>"NCT06222177", "acronym"=>"SLR obese", "briefTitle"=>"Thresholds of SLR Maneuver in Obese Patients", "organization"=>{"class"=>"OTHER", "fullName"=>"IRCCS Policlinico S. Donato"}, "officialTitle"=>"Defining High-resolution Manometry Thresholds of Backward Pressure Across the Lower Esophageal Sphincter Through Straight Leg Raise Maneuver in Obese Patients", "orgStudyIdInfo"=>{"id"=>"SLR_Obese"}}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"GERD group", "description"=>"Patients with AET\\>6% at pH-study", "interventionNames"=>["Diagnostic Test: Pathophysiologic evaluation"]}, {"label"=>"Non GERD group", "description"=>"Patients with AET\\<6% at pH-study", "interventionNames"=>["Diagnostic Test: Pathophysiologic evaluation"]}], "interventions"=>[{"name"=>"Pathophysiologic evaluation", "type"=>"DIAGNOSTIC_TEST", "description"=>"High-resolution manometry and pH study", "armGroupLabels"=>["GERD group", "Non GERD group"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"20097", "city"=>"San Donato Milanese", "state"=>"Milan", "status"=>"RECRUITING", "country"=>"Italy", "contacts"=>[{"name"=>"Sara Boveri", "role"=>"CONTACT", "email"=>"sara.boveri@grupposandonato.it"}], "facility"=>"IRCCS Policlinico San Donato", "geoPoint"=>{"lat"=>45.41047, "lon"=>9.26838}}], "centralContacts"=>[{"name"=>"Stefano Siboni", "role"=>"CONTACT", "email"=>"stefano.siboni@grupposandonato.it", "phone"=>"+393493232750"}, {"name"=>"Marco Sozzi", "role"=>"CONTACT", "email"=>"marco.sozzi@grupposandonato.it"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"IRCCS Policlinico S. Donato", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"Medical University of Vienna", "class"=>"OTHER"}, {"name"=>"University of Campania \"Luigi Vanvitelli\"", "class"=>"OTHER"}, {"name"=>"Università Vita-Salute San Raffaele", "class"=>"OTHER"}], "responsibleParty"=>{"type"=>"SPONSOR"}}}}
