[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100421147":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":30,"locations":26,"responsibleParty":40,"collaborators":26,"id":42,"slug":43,"hasResults":44,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":44,"sex":50,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":26,"studyType":56,"phases":57,"briefSummary":59,"conditions":60,"keywords":63,"overallStatus":68,"whyStopped":26,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":26},{"fullName":5,"class":6},"Niguarda Hospital","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"RYGBP","ACTIVE_COMPARATOR","RYGBP: Roun-en-Y Gastric Bypass",[13,14],"Procedure: Roux-en-Y-Gastric bypass, Sleeve gastrectomy","Procedure: SG",{"label":16,"type":17,"description":18,"interventionNames":19},"SG","EXPERIMENTAL","SG: Sleeve Gastrectomy",[13,14],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Roux-en-Y-Gastric bypass, Sleeve gastrectomy","RYGBP consists in creating a small gastric pouch along the little curvature of the stomach, followed by the section of the small bowel. The restoration of the gastro-intestinal tract is achieved by performing a gastro-jejunal and a jejuno-jejunal anastomosis, giving this procedure the characteristic aspect of a Y. Also, for RYGBP the laparoscopic approach requires the placement of 5 trocars in the upper part of the abdomen.",[9,16],null,{"type":22,"name":16,"description":28,"armGroupLabels":29,"otherNames":26},"SG consists in removing the fundus and the body of the stomach, along the greater curvature. To perform it with a laparoscopic approach, we create the pneumoperitoneum with Veress needle and place 5 trocars in the upper part of the abdomen. The first step is the dissection of the greater curvature of the stomach, that starts at 6 centimetres from pylorus and it's conducted up to the angle of His, freeing the fundus and exposing the left pillar. A 38 Fr bougie is placed inside the stomach to calibrate its section. After it is carried out, the specimen is removed from the greater trocar site.",[9,16],[31,37],{"name":32,"role":33,"phone":34,"phoneExt":35,"email":36},"Gisella Barone, MD","CONTACT","+39 026444","7918","gisella.barone89@gmail.com",{"name":38,"role":33,"phone":34,"phoneExt":35,"email":39},"Valerio Girardi, MD","valerio.girardi@ospedaleniguarda.it",{"type":41,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100421147","reflux-disease-after-gastric-bypass-versus-sleeve-gastrectomy-in-morbid-obese-patients-an-italian-study-100421147",false,"NCT04763993","Reflux Disease After Gastric Bypass Versus Sleeve Gastrectomy in Morbid Obese Patients: an Italian Study","Reflux Disease After Gastric Bypass Versus Sleeve Gastrectomy in Morbid Obese Patients: an Italian Monocentric Randomized Clinical Study (ReBvSS)","ReBvSS","Inclusion Criteria:\n\n* Acceptance of randomization to surgery;\n* Participant is willing and able to give informed consent for participation in the trial;\n* Written informed consent;\n* Compliance to follow-up;\n* Male and female;\n* ≥18 and ≤70 years old;\n* BMI ≥ 35 with obesity-related comorbidities;\n* BMI ≥ 40 with or without obesity-related comorbidities;\n* GERDQ score ≥ 3 points;\n* Use of proton pump inhibitor;\n* Mild and Moderate GERD (DMS ≥14.72 ≤100)\n* Incompetence of the Esophagogastric junction\n* Los Angeles grade A, B, C, D esophagitis.\n\nExclusion criteria\n\n* Medical or psychiatric conditions that compromises the patient's ability to give informed consent or comply with the study protocol;\n* Barrett's esophagus (BE);\n* Spastic motor disorders and esophageal hypomotility;\n* Peptic strictures;\n* Absence of GERD (DMS\\\u003C14.72);\n* Severe GERD (DMS\\>100);\n* Hiatal hernia \\> 5 cm;\n* Previous bariatric surgery or major general surgery;\n* Type 2 diabetes (T2D) for more than \\> 5 years;\n* Necessity to explore stomach, the duodenum or the biliary tract;\n* Refuse of randomization;\n* Personal reasons.","ALL","18 Years","70 Years",{"count":54,"type":55},128,"ESTIMATED","INTERVENTIONAL",[58],"NA","The study aims to clarify if GERD, defined by results of 24 hours potential of hydrogen (pH) monitoring and abnormal DeMeester Score (DMS), in obese patients could worsen after Sleeve Gastrectomy (SG) more than after RYGBP. To demonstrate this hypothesis, the investigators will study the obese population suspected for GERD with 24 hours monitoring and High-Resolution Esophageal Manometry (HRM). DMS is calculated pre-operatively and, once GERD is confirmed, the patients are enrolled for randomization to SG or RYGBP. The suspicion of GERD is investigated with the GERDQ score and EGDS, that all obese patients have pre-operatory.",[61,62],"Gastroesophageal Reflux Disease","Obesity",[61,62,64,65,66,67],"Sleeve gastrectomy","Gastric bypass","DeMeester score","pH-monitoring","NOT_YET_RECRUITING","2026-04-13",{"date":71,"type":72},"2026-04-16","ACTUAL",{"date":74,"type":55},"2026-05-01",{"date":76,"type":55},"2030-05-01",{"name":5,"class":6}]