[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"esophagitis-peptic\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:esophagitis-peptic":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":28,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":42,"leadSponsor":44,"locationsCount":5},"100655300","preoperative-predictors-of-symptom-improvement-after-laparoscopic-fundoplication-100655300",false,"NCT07809620","Preoperative Predictors of Symptom Improvement After Laparoscopic Fundoplication","Preoperative Predictors of Clinically Significant Symptom Improvement Twelve Months After Laparoscopic Fundoplication for Gastroesophageal Reflux Disease: A Prospective Observational Cohort Study","Inclusion Criteria:\n\n* Adults aged 18 years or older.\n* Objectively documented gastroesophageal reflux disease, defined by at least one of the following: pathological acid exposure on off-PPI 24-hour pH or pH-impedance monitoring; Los Angeles grade C or D esophagitis; biopsy-proven Barrett's esophagus; or a positive symptom-reflux association.\n* Medically refractory or PPI-dependent disease, troublesome regurgitation, or a symptomatic hiatal hernia, with an elective decision for laparoscopic fundoplication.\n* Able to provide written informed consent and to complete the study questionnaires.\n\nExclusion Criteria:\n\n* Previous antireflux or other major foregut or esophagogastric surgery.\n* Achalasia or a major esophageal motility disorder on high-resolution manometry (Chicago Classification version 4.0): absent contractility, esophagogastric junction outflow obstruction, distal esophageal spasm, or hypercontractile esophagus.\n* Giant or complex paraesophageal hernia requiring non-standard reconstruction, or a concurrent bariatric or other major intra-abdominal procedure.\n* Esophageal or gastric malignancy.\n* Emergency surgery.\n* Pregnancy.\n* Inability to complete patient-reported outcome instruments or to attend follow-up.","ALL","18 Years",{"count":19,"type":20},470,"ESTIMATED","OBSERVATIONAL","Laparoscopic fundoplication is the standard operation for gastroesophageal reflux disease (GERD) that does not respond adequately to medication, and it relieves reflux symptoms in most patients who are carefully selected for it. Even so, published studies consistently report that between 10% and 30% of patients continue to have symptoms afterwards, develop troublesome side effects such as difficulty swallowing or bloating, or are dissatisfied with the result. Much of this disappointment reflects who was chosen for surgery rather than any technical fault in the operation: patients whose symptoms are not actually caused by acid reflux predictably gain little benefit from a well-constructed wrap.\n\nIndividual factors measured before surgery, such as the amount of acid in the esophagus, the link between symptoms and reflux episodes, the type of symptoms, and how well the patient responded to acid-suppressing tablets, have each been linked to the outcome. However, most of that evidence comes from retrospective studies that used different definitions of success, so it is still unclear which factors matter independently once they are considered together.\n\nThis study will follow adults with objectively confirmed GERD who are scheduled for elective laparoscopic fundoplication at Minia University Hospitals. Before surgery, every participant undergoes the same standardized assessment: upper endoscopy, 24-hour pH-impedance monitoring off acid-suppressing medication, high-resolution manometry, measurement of height and weight, and questionnaires covering reflux symptoms, anxiety, depression and physical symptom burden. Participants then complete validated symptom questionnaires again at 1, 3, 6 and 12 months after the operation.\n\nThe main measure of success is \"responder status\" at 12 months, meaning at least a 50% improvement in the total GERD-HRQL symptom score compared with before surgery, supported by the patient's own rating of satisfaction. The investigators will analyze ten factors recorded before surgery to determine which of them independently predict this outcome, and will use the results to build and test a prediction tool that surgeons can apply during preoperative counseling.\n\nThe study does not assign any treatment. The type of wrap performed, either a complete (Nissen) or a partial posterior (Toupet) fundoplication, is chosen by the treating surgeon according to a prespecified rule based on esophageal motility, exactly as in routine practice. Taking part involves completing questionnaires and attending the usual follow-up appointments, and adds no additional procedural risk.",[24,25,26,27],"Gastroesophageal Reflux Disease","Hiatal Hernia","Esophagitis, Peptic","Barrett Esophagus",[29,30,31,32,33,34,35],"Fundoplication","Nissen fundoplication","Toupet fundoplication","Antireflux surgery","GERD-HRQL","Esophageal pH monitoring","High-resolution manometry","RECRUITING","2026-09-20",{"date":39,"type":40},"2026-09-22","ACTUAL",{"date":37,"type":40},{"date":43,"type":20},"2028-12-20",{"name":45,"class":46},"Minia University","OTHER"]