Preoperative Predictors of Symptom Improvement After Laparoscopic Fundoplication

NCT07809620 | Recruiting DMC

• 1 other identifier: 2132:9/26
• Study Type: observational
• Target: 470
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gastroesophageal Reflux Disease; Hiatal Hernia; Esophagitis, Peptic; Barrett Esophagus

Keywords

Fundoplication; Nissen fundoplication; Toupet fundoplication; Antireflux surgery; GERD-HRQL; Esophageal pH monitoring; High-resolution manometry

Outcome Measures

Primary Outcomes (1)

• Responder status: proportion of participants achieving clinically significant symptom improvement

  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.

  12 months after surgery

Secondary Outcomes (9)

• Change from baseline in total GERD-HRQL score

  Baseline and 1, 3, 6 and 12 months after surgery

• Change from baseline in GerdQ score

  Baseline and 1, 3, 6 and 12 months after surgery

• Discontinuation of antisecretory therapy

  12 months after surgery

• Resolution of regurgitation

  2 months after surgery

• New or persistent dysphagia

  12 months after surgery

Other Outcomes (2)

• Normalization of esophageal acid exposure

  12 months after surgery

• Performance of the multivariable prediction model

  At final analysis, after all participants complete 12-month follow-up

Study Arms (2)

Complete (Nissen) fundoplication

Participants with normal esophageal body motility on high-resolution manometry (Chicago Classification version 4.0) who undergo laparoscopic complete 360-degree fundoplication, fashioned as a short floppy 1.5-2 cm wrap calibrated over a 56-60 Fr bougie. Allocation is by the treating team according to the prespecified motility-based algorithm reflecting routine care, not by the study.

Procedure: Laparoscopic Nissen fundoplication

Partial posterior (Toupet) fundoplication

Participants with ineffective esophageal motility on high-resolution manometry (Chicago Classification version 4.0) who undergo laparoscopic posterior partial 270-degree fundoplication. Allocation is by the treating team according to the prespecified motility-based algorithm reflecting routine care, not by the study.

Procedure: Laparoscopic Toupet fundoplication

Interventions

Laparoscopic Toupet fundoplication PROCEDURE

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.

Also known as: Toupet fundoplication; posterior partial 270-degree wrap

Partial posterior (Toupet) fundoplication

Laparoscopic Nissen fundoplication PROCEDURE

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.

Also known as: Nissen fundoplication; complete 360-degree wrap

Complete (Nissen) fundoplication

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive adults with objectively documented gastroesophageal reflux disease who are scheduled for elective laparoscopic fundoplication at a tertiary referral center for foregut surgery. Patients are identified and enrolled at the time of preoperative assessment.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Minia University: lead

Study Sites (1)

Minia University Hospitals - Department of Surgery, Faculty of Medicine, Minia University

Minya, Minya Governorate, 61519, Egypt

RECRUITING

MeSH Terms

Conditions

Gastroesophageal Reflux; Hernia, Hiatal; Esophagitis, Peptic; Barrett Esophagus

Interventions

Fundoplication

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Hernia, Diaphragmatic; Internal Hernia; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Esophagitis; Gastroenteritis; Peptic Ulcer; Duodenal Diseases; Intestinal Diseases; Stomach Diseases; Precancerous Conditions; Neoplasms

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Saleh K Saleh, MD

  Minia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Saleh K Saleh, MD

CONTACT

01201765401; salehkhairy@mu.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of General Surgery, Department of Surgery, Faculty of Medicine

Study Record Dates

• First Submitted: September 3, 2026
• First Posted: September 9, 2026
• Study Start: September 20, 2026
• Primary Completion (Estimated): September 20, 2028
• Study Completion (Estimated): December 20, 2028
• Last Updated: September 22, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)