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Preoperative Predictors of Symptom Improvement After Laparoscopic Fundoplication

Recruitingn/aAges 18 Years - anyAllMinia University
NCT07809620 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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. Individual 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

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📋 Eligibility rules (as published)
Inclusion Criteria: * Adults aged 18 years or older. * 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. * Medically refractory or PPI-dependent disease, troublesome regurgitation, or a symptomatic hiatal hernia, with an elective decision for laparoscopic fundoplication. * Able to provide written informed consent and to complete the study questionnaires. Exclusion Criteria: * Previous antireflux or other major foregut or esophagogastric surgery. * 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. * Giant or complex paraesophageal hernia requiring non-standard reconstruction, or a concurrent bariatric or other major intra-abdominal procedure. * Esophageal or gastric malignancy. * Emergency surgery. * Pregnancy. * Inability to complete patient-reported outcome instruments or to attend follow-up.
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What it tests

  • Laparoscopic Nissen fundoplication
  • Laparoscopic Toupet fundoplication
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Where

1 site
Minia University Hospitals - Department of Surgery, Faculty of Medicine, Minia University
Minya, Egypt
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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