[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"esophagus-injury\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:esophagus-injury":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100475848","suprasorb-cnpendo-used-for-negative-pressure-therapy-in-the-oesophagus-and-rectum-to-support-defect-and-wound-healing-100475848",false,"NCT05476263","Suprasorb® CNPendo Used for Negative Pressure Therapy in the Oesophagus and Rectum to Support Defect and Wound Healing","Non-interventional, Observational, Prospective, Multicentre Study in a Routine Clinical Care Setting Using a Marketed Medical Device in Line With the Corresponding IFU in the Intended Patient Population","Velox","Inclusion Criteria:\n\n* ≥ 18 years of age\n* Acute transmural defects, injuries and wounds in oesophagus or rectum, including perforations (iatrogenic or spontaneous) and anastomotic insufficiencies (Index defect)\n* Indication of treatment with Suprasorb® CNPendo system according to IFU and medical guidelines\n* Signed informed consent for usage of data\n\nExclusion Criteria:\n\n* Pre-existing coagulation disorders with increased risk of bleeding\n* Defects involving the bronchial system (bronchus\u002Ftrachea\u002Fpulmo)\n* Any foreseeable deviation from IFU of Suprasorb® CNP endo\n* Known intolerance or allergy to one or more components of Suprasorb® CNPendo","ALL","18 Years",{"count":20,"type":21},110,"ESTIMATED","3 Months","OBSERVATIONAL","A Post-Market Clinical Follow-up (PMCF) study designed as non-interventional, observational, prospective, multicentre study in a routine clinical care setting using a marketed medical device in line with the corresponding Instruction for Use (IFU) in the intended patient population.\n\nPatients will be diagnosed and evaluated for eligibility in routine clinical care by expert centres in the indication of interest. They will be consecutively enrolled into the study provided that all inclusion and exclusion criteria are met and written consent is given to use their clinical routine data according to data privacy regulations.\n\nThe study protocol does not define specific study procedures for patients enrolled. Therapies and procedures during the course of this study will be performed according to the decision of the treating physician based on current applicable medical guidelines and on local policy in clinical routine care.",[26,27],"Esophagus Injury","Rectal Lesion","RECRUITING","2025-09-11",{"date":31,"type":32},"2025-09-12","ACTUAL",{"date":34,"type":32},"2024-06-03",{"date":36,"type":21},"2027-09",{"name":38,"class":39},"Lohmann & Rauscher","INDUSTRY",7,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":53,"phases":54,"briefSummary":56,"conditions":57,"keywords":61,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":5},"100464685","crural-repair-during-laparoscopic-sleeve-gastrectomy-in-patients-with-a-lax-gastroesophageal-junction-100464685","NCT05330910","Crural Repair During Laparoscopic Sleeve Gastrectomy in Patients With a Lax Gastroesophageal Junction","A Randomized Controlled Trial Evaluating PAtients With Lax Gastroesophageal Junction to Initial Sleeve Gastrectomy With or Without Concomitant Crural Repair (REPAIR)","REPAIR","Inclusion Criteria:\n\n* 21-65 years old\n* Able to provide informed consent\n* Hill's grade III gastroesophageal junction on preoperative endoscopy\n* Opted to undergo laparoscopic sleeve gastrectomy as their bariatric procedure\n\nExclusion Criteria:\n\n* Unable or unwilling to provide informed consent\n* Contraindications to laparoscopic sleeve gastrectomy\n* Opted not to undergo laparoscopic sleeve gastrectomy\n* Had previous upper gastrointestinal surgery\n* Had documented erosive esophagitis on preoperative endoscopy\n* Had Hill's grade I, II or IV gastroesophageal junction on preoperative endoscopy","21 Years","65 Years",{"count":52,"type":21},96,"INTERVENTIONAL",[55],"NA","Background:\n\nLaparoscopic sleeve gastrectomy (LSG) is one of the commonest bariatric procedures. However, it is associated with postoperative gastroesophageal reflux disease (GERD) and erosive esophagitis (EE). The investigators' preliminary study suggests that the incidence of postoperative GERD and EE appears to be correlated with the preoperative presence of a lax gastroesophageal flap valve and hiatal hernia.\n\nHypothesis\u002F Aim:\n\nTo investigate the impact of a concomitant hiatal hernia repair with LSG on the incidence of postoperative EE.\n\nSignificance:\n\nFor patients with pre-existing EE, most surgeons will recommend a laparoscopic Roux-en-Y gastric bypass (LRYGB) as their primary bariatric procedure. However, compared to LSG, LRYGB is a technically more demanding procedure with increased morbidity and long term nutritional deficiencies. For asymptomatic patients at risk of postoperative EE due to presence of a hiatal hernia, there is still no consensus on the most appropriate bariatric surgical option. A LSG with a concomitant hiatal hernia repair, if shown to reduce EE postoperatively, may help to expand the pool of patients suitable for LSG in the future.\n\nMethods:\n\nA two center, double-blinded, randomized controlled trial of all patients, undergoing LSG with a preoperative diagnosis of a Hill's grade III gastroesophageal junction, will be randomized to having a concomitant hiatal hernia repair (experimental arm) versus just LSG alone (control arm). Primary outcome measures include 1-year postoperative EE on endoscopy. Secondary outcome measures include postoperative morbidity, blood loss, quality of life and GERD symptoms at 1-year postoperatively.",[58,59,26,60],"Obesity","Bariatric Surgery Candidate","Gastroesophageal Reflux",[58,62,63,64,65],"Bariatric Surgery","Esophagitis","Gastroesophageal reflux disease","Laparoscopic sleeve gastrectomy","2022-04-10",{"date":68,"type":32},"2022-04-15",{"date":70,"type":32},"2022-04-01",{"date":72,"type":21},"2028-04-30",{"name":74,"class":75},"Sengkang General Hospital","OTHER"]