Not Yet RecruitingNot Applicable

Comparison of Laparoscopic Nissen Fundoplication and Hill-Snow Repair for Hiatus Hernia With Endoscopic Evaluation

Egypt40 participantsStarted 2026-03

Plain-language summary

The goal of this clinical trial is to compare the clinical efficacy and safety of laparoscopic Nissen fundoplication (LNF) versus laparoscopic Hill-Snow repair (LHS) in the management of patients with congenital hiatus hernia, to evaluate the role of upper gastrointestinal endoscopy in the preoperative diagnosis and planning \& to determine the utility of intraoperative endoscopy in guiding the surgical repair and ensuring its technical adequacy. main questions are: * which one of these techniques is safer with higher clinical efficacy represented by relief of GERD symptoms ? * does upper GI endoscopy have a role in preoperative stage regarding diagnosis of condition and planning of treatment ? * does upper GI endoscopy have a role in intraoperative stage regarding guiding the surgical repair and ensuring its adequacy ? all participants will be randomly assigned in one of two groups: * one group undergoing Laparoscopic Nissen Fundoplication * the other group undergoing Laparoscopic Hill-Snow repair each participsant will have preopertive, intraoperative and postoperative upper GI endoscopy to assess objectively clinical efficacy of both techniques and to define the integral role of endoscopy in all three perioperative stages

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients aged less than 18 years including both sexes with a confirmed diagnosis of congenital hiatus hernia * Diagnosis of hiatus hernia refractory to maximal medical therapy (PPI for ≥12 weeks) AND/OR presence of complications (e.g., erosive esophagitis, Barrett's esophagus, recurrent aspiration pneumonia, failure to thrive) * Objective evidence of pathological GERD on upper endoscopy e.g: erosive esophagitis, Barrett's esophagus. Exclusion Criteria: * Previous esophageal or gastric surgery * Contraindications to laparoscopy e.g: cardiopulmonary decompensated cases.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Degree of relief of GERD symptoms assessed by GERD Health-Related Quality Of Life (GERD-HRQL) score

Timeframe: 6 months postoperatively

Trial details

NCT IDNCT07387042

SponsorMinia University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-07

Contact for this trial

Mohamed H Hamdy, Master

+201064771480 mhh_raheel92@yahoo.com

View on ClinicalTrials.gov More Hiatal Hernia With Gastroesophageal Reflux Disease trials