Predictors of symptom improvement after laparoscopic fundoplication

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study looks at adults with GERD-related conditions who are planned for laparoscopic fundoplication (Nissen or Toupet). It aims to identify preoperative tests and symptom patterns that correlate with better postoperative outcomes. Data will come from preoperative assessments and postoperative symptom questionnaires to see which factors align with improved relief and fewer side effects. The study is conducted at Minia University Hospitals and does not involve an intervention beyond standard surgical care.

Why it matters

Who can join: the full rules

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.

Where it's running

• Minia University Hospitals - Department of Surgery, Faculty of Medicine, Minia University
  Minya, Minya Governorate, Egypt Recruiting

Study contacts

• Principal investigator: Saleh K Saleh, MD — Minia University
• Study coordinator: Saleh K Saleh, MD
• Email: salehkhairy@mu.edu.eg
• Phone: 01201765401

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.