[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100595876":3},{"organization":4,"outcomesModule":7,"designInfo":28,"detailedDescription":36,"studyPopulation":33,"armGroups":37,"interventions":44,"overallOfficials":33,"centralContacts":50,"locations":56,"responsibleParty":83,"collaborators":33,"id":87,"slug":33,"hasResults":88,"nctId":89,"briefTitle":90,"officialTitle":90,"acronym":33,"eligibilityCriteria":91,"healthyVolunteers":88,"sex":92,"minAge":93,"maxAge":94,"enrollmentInfo":95,"targetDuration":33,"studyType":98,"phases":99,"briefSummary":100,"conditions":101,"keywords":33,"overallStatus":59,"whyStopped":33,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"Kasr El Aini Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":24},[9,13],{"measure":10,"description":11,"timeFrame":12},"Nutritional Status","nutritional status of patient will be assessed by general examination, assessment of lower limb edema, serum albumin and hemoglobin","one year",{"measure":14,"description":15,"timeFrame":12},"Weight Regain","The initial weight at the time of the procedure will be measured in kg, and at follow-up, it will be reassessed at three, six, and twelve months. Weight assessment will be part of the BMI assessment in kg\u002Fm2",[17,20],{"measure":18,"description":19,"timeFrame":12},"Quality of Life","The Short Form 36 (SF-36) questionnaire will be used to assess quality of life and overall health status.",{"measure":21,"description":22,"timeFrame":23},"GERG symptoms","GERD symptoms will be assessed at three, six, and twelve months of follow-up. The GERD-Health Related Quality of Life (GERD-HRQL) Questionnaire will be used in this study.","One year",[25],{"measure":26,"description":27,"timeFrame":23},"Possible Risks","1. Post operative pain.\n2. Post operative nausea and vomiting.\n3. Bleeding\n4. Anastomotic leakage\n5. Stricture",{"allocation":29,"interventionModel":30,"interventionModelDescription":31,"primaryPurpose":32,"observationalModel":33,"timePerspective":33,"maskingInfo":34},"NA","SINGLE_GROUP","This is a prospective single-arm clinical trial that will include patients who had gastric bypass done - both RYGB and OAGB-, who developed complications of bypass and are candidates for reversal, but still keen to keep weight loss or even add more weight loss.","TREATMENT",null,{"masking":35,"maskingDescription":33,"whoMasked":33},"NONE","Objectives: To study efficacy, safety, and patient outcomes following laparoscopic gastric bypass conversion to sleeve gastrectomy.\n\nStudy population \\& Sample size :\n\nAdult patients undergoing single-stage laparoscopic stapled conversion of gastric bypass to sleeve gastrectomy in Kasr Alainy Sample size: 11 patients Study Design: This is a prospective single-arm clinical trial.\n\nMethods: Patients who will attend our bariatric outpatient clinic will be enlisted according to inclusion criteria. A detailed history of anthropometric measures, chronic diseases, and previous surgeries will be recorded. After patient education, preoperative routine labs and imaging will be performed.\n\nA preoperative 3D gastric volumetry CT scan will be performed to all patients included in this study.\n\nThe procedure will consist of converting the gastric bypass to a sleeve gastrectomy using a stapling technique.\n\nThe average length of hospital stay will be included. Follow up of nutritional status will be done using laboratory parameters (Hb, Ferritin, Vitamin D, Zn, Mg, serum Albumin, Calcium) in 3 months and 6 months postoperatively, quality of life will be assessed using bariatric quality of life index in 3 months and 6 months postoperatively.\n\nPatient weight will be documented monthly to evaluate weight regain, GERD symptoms will be assessed using GERD score in 3 months and 6 months postoperatively.\n\nPossible Risk (s) to study population:\n\n1. Postoperative pain.\n2. Postoperative nausea and vomiting.\n3. Bleeding\n4. Anastomotic leakage\n5. Stricture\n\nOutcome parameters:\n\n* Primary outcomes\n\n  1. Improvement of nutritional status.\n  2. Weight regain.\n* Secondary outcome parameters\n\n  1. Quality of life\n  2. GERD symptoms\n\nStatistical analysis plan:\n\nData analysis packages will be SPSS version 21. Qualitative data will be presented by number and percentage, quantitative data will be presented by mean, standard deviation, median, and interquartile range.\n\nParametric and non-parametric tests of significant will be done (chi-square, student t-test, and Mann-Whitney test).\n\nCorrelation analysis tests and regression will be done. The level of significance was set at p equal to or below 0.05.",[38],{"label":39,"type":40,"description":41,"interventionNames":42},"Candidates of several of bypass to sleeve","EXPERIMENTAL","This interventional study with a single arm assesses the effectiveness and safety of converting gastric bypass to sleeve gastrectomy using a laparoscopic stapling technique in adults who have complications from earlier gastric bypass procedures. The approach entails closing the prior gastrojejunostomy and performing a sleeve gastrectomy with a stapling method. The outcomes measured will include enhancements in nutritional status, weight regain, quality of life, and symptoms of GERD over a follow-up period of 6 months.",[43],"Procedure: Stapled reversal of gastric bypass to sleeve gastrectomy utilising stapling technique.",[45],{"type":46,"name":47,"description":48,"armGroupLabels":49,"otherNames":33},"PROCEDURE","Stapled reversal of gastric bypass to sleeve gastrectomy utilising stapling technique.","This research entails a single-stage laparoscopic conversion of gastric bypass to sleeve gastrectomy. The procedure entails the closure of the gastrojejunostomy with an endo-stapler and the reconstruction of the stomach by resecting along the greater curvature to create a sleeve gastrectomy. An intraoperative leak test will be conducted using methylene blue. Patients are monitored postoperatively for at least 24 hours, with subsequent assessments of nutritional status, weight, gastroesophageal reflux disease (GERD) symptoms, and quality of life at 3 and 6 months.",[39],[51],{"name":52,"role":53,"phone":54,"phoneExt":33,"email":55},"Associate Professor of General and Laparosocpic Surgery","CONTACT","+201111577188","a.abd.elsalam@kasralainy.edu.eg",[57],{"facility":58,"status":59,"city":60,"state":61,"zip":62,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":70,"contacts":71},"Kasr Alainy Medical School, Cairo University","RECRUITING","Cairo","Old Cairo","11956","Egypt","EG",{"type":66,"coordinates":67},"Point",[68,69],31.24967,30.06263,{"lat":69,"lon":68},[72,76,79,81],{"name":73,"role":53,"phone":74,"phoneExt":33,"email":75},"Maher Fawzy, Doctorate","+201222166937","kasralainyrec@kasralainy.edu.eg",{"name":77,"role":78,"phone":33,"phoneExt":33,"email":33},"Ahmed M Ghobashy, Doctorate","SUB_INVESTIGATOR",{"name":80,"role":78,"phone":33,"phoneExt":33,"email":33},"Ahmed M Abdelatif, Doctorate",{"name":82,"role":78,"phone":33,"phoneExt":33,"email":33},"Ahmed Y Khaled, Doctor",{"type":84,"investigatorFullName":85,"investigatorTitle":86,"investigatorAffiliation":5,"oldNameTitle":33,"oldOrganization":33},"PRINCIPAL_INVESTIGATOR","Ahmed Abdelsalam M","Associate Professor of General and Laparoscopic Surgery","100595876",false,"NCT07038148","Exploring the Efficacy of Single-stage Stapled Conversion of Gastric Bypass to Sleeve Gastrectomy, More Leak?","Inclusion Criteria:\n\n* Age between 18-70\n* Adult patients undergoing single-stage laparoscopic stapled conversion of gastric bypass to sleeve gastrectomy.\n* Patients accept to sign an informed consent and will commit to follow-up.\n\nExclusion Criteria:\n\n* Patients with reversal gastric bypass to normal anatomy.\n* Patient with uncontrolled systemic disease.\n* Patients with active psychological disorders.\n* Patients with active substance abuse.\n* Patients with intra-operative technical difficulties hindering the conversion of gastric bypass to sleeve gastrectomy.\n* Patients refusing to sign an informed consent.","ALL","18 Years","70 Years",{"count":96,"type":97},11,"ESTIMATED","INTERVENTIONAL",[29],"Laparoscopic gastric bypass - including both Roux-en-Y gastric bypass (RYGB) and one anastomosis gastric bypass (OAGB) - is one of the most frequently performed procedures. However, as the number of gastric bypass surgeries increases, complications are being reported more often. While most post-bypass complications can be managed non-surgically, a small number of persistent cases may require a reversal to normal anatomy or conversion to another procedure.\n\nMany patients who experience severe complications from gastric bypass are reluctant to undergo a reversal to normal anatomy due to fears of regaining weight. As a result, converting to another type of surgery becomes a more logical alternative.\n\nComplications requiring conversion are numerous and negatively affect the quality of life, such as retrograde intussusception, weight regain, intractable dumping syndrome, and nutritional deficiencies. The high cost of obligatory postoperative vitamins is a potential cause of conversion especially in low-income countries.\n\nThe conversion procedure is technically demanding and has a relatively higher rate of postoperative complications, making it less commonly performed. Additionally, limited data is available regarding the procedure and its long-term outcomes, making it an unexplored sea of hope for people who wish to manage intractable complications of gastric bypass and maintain weight loss.",[102],"the Focus of the Study is to Assees Efficacy of Stapled Revision of Gastric Bypass to Sleeve Gastrectomy","2025-06-17",{"date":105,"type":106},"2025-06-26","ACTUAL",{"date":108,"type":106},"2025-01-25",{"date":110,"type":97},"2026-01-30",{"name":5,"class":6},1]