Preoperative Predictors of Symptom Improvement After Laparoscopic Fundoplication

Condition(s) studied

Investigational drug(s) / intervention(s)

Laparoscopic Nissen fundoplication: Standardized laparoscopic complete 360-degree fundoplication with complete hiatal dissection, preservation of the vagi, circumferential mobilization of the distal esophagus to at least 2.5 cm of tension-free intra-abdominal length, posterior crural approximation, and division of short gastric vessels as required. Performed as part of routine clinical care and observed by the study.

Laparoscopic Toupet fundoplication: Standardized laparoscopic posterior partial 270-degree fundoplication using the same hiatal dissection and esophageal mobilization as for the complete wrap. Performed as part of routine clinical care and observed by the study.

Study summary

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 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.

This 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.

The 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.

The 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.

Eligibility

Primary outcome measure(s)

• Responder status: proportion of participants achieving clinically significant symptom improvement — 12 months after surgery
  Proportion of participants classified as responders. A responder is a participant with a reduction of at least 50% in the total Gastroesophageal Reflux Disease Health-Related Quality of Life (GERD-HRQL) score relative to baseline, corroborated by the patient's global satisfaction rating. The GERD-HRQL comprises 10 symptom items each scored from 0 (no symptoms) to 5 (symptoms incapacitating), giving a total score from 0 to 50, with higher scores indicating worse reflux-related quality of life, together with a separate global item on satisfaction with present condition. The outcome is analyzed as a binary variable, responder versus non-responder, and modeled against ten prespecified preoperative predictors by multivariable logistic regression with age and sex forced as covariates.

Trial sites (1)

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