An interventional study of Laparoscopic Hill-Snow repair and Laparoscopic Nissen Fundoplication in Hiatal Hernia With Gastroesophageal Reflux Disease, sponsored by Minia University. Not yet recruiting at 1 site in Egypt. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2026-02-04.
Sponsored by Minia University · Not applicable, Interventional, and Treatment
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:
all participants will be randomly assigned in one of two groups:
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
Congenital hiatus hernia (CHH), though less common than acquired forms, presents a significant clinical challenge, particularly in the pediatric and young adult populations. It is characterized by a congenital defect in the phrenoesophageal membrane, allowing for herniation of gastric cardia into the mediastinum. This anatomical disruption compromises the lower esophageal sphincter (LES) mechanism, leading to severe gastroesophageal reflux disease (GERD), which can result in failure to thrive, esophagitis, recurrent aspiration pneumonia, and long-term sequelae like Barrett's esophagus.
When medical management fails or in cases of significant complications, surgical intervention is imperative. The goals of surgery are the anatomical reduction of the hernia, reconstruction of the esophagogastric junction (EGJ), and restoration of an effective anti-reflux barrier. Laparoscopic repair has become the gold standard due to its benefits of reduced postoperative pain, shorter hospital stay, and better cosmesis.
Two prominent laparoscopic techniques are:
Laparoscopic Nissen Fundoplication (LNF): A 360-degree wrap is the most common anti-reflux procedure worldwide. It is highly effective in controlling reflux but is associated with potential side effects like gas-bloat syndrome, dysphagia, and inability to belch.
Laparoscopic Hill-Snow Repair (LHS): This technique focuses on a precise anatomical restoration of the EGJ by anchoring it to the median arcuate ligament of the diaphragm. It aims to recreate the valvular mechanism without a complete wrap, potentially reducing the typical side effects of Nissen fundoplication.
Endoscopy plays a crucial but often under-standardized role in the perioperative management of CHH.
Preoperatively, it is essential for diagnosing esophagitis, Barrett's metaplasia, and ruling out other pathologies. It also helps in assessing the size and reducibility of the hernia.
Intraoperatively, endoscopy (laparoscopic-endoscopic collaboration) can guide the surgeon in assessing the tightness of the fundoplication, identifying the Z-line for accurate placement of the wrap, and ensuring no mucosal perforation has occurred.
Postoperatively, endoscopy is the primary tool for evaluating anatomical success, detecting recurrence, and managing persistent symptoms like dysphagia.
While numerous studies have compared various fundoplication techniques for GERD, there is a paucity of literature directly comparing LNF and LHS specifically in the context of congenital hiatus hernia. Furthermore, a systematic protocol defining the integral role of endoscopy in all three perioperative stages is lacking. This study aims to fill this gap by providing a comparative analysis of the functional outcomes and complications of these two techniques and by establishing a standardized perioperative endoscopic protocol.
87 studies on the registry are indexed under Hernia, Hiatal; 27 are open to participants now.
This study's planned enrollment of 40 is below the median of 100 across 56 interventional studies indexed under Hernia, Hiatal.
Browse Hernia, Hiatal studies →Minia University is the lead sponsor of 370 studies on the registry; 117 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Procedure: Laparoscopic Hill-Snow repair
Procedure: Laparoscopic Nissen Fundoplication
a laparoscopic surgical operation to fix severe acid reflux (GERD) and hiatal hernias by restoring the natural anti-reflux mechanism,acting as an alternative to the more common Nissen fundoplication, It's known for firmly anchoring the stomach to reliable structures, creating a flap valve, and reducing recurrence What it does * Reduces hiatal hernia: Pulls down the stomach that has slipped into the chest. * Recreates valve: Re-establishes the angle of His (the valve between the esophagus and stomach). * Secures the junction: Sews the lower esophagus and stomach to the diaphragm and abdominal structures, preventing reflux How it works (basic steps) Dissect: Free the esophagus and pull down the herniated stomach. Repair hernia: Close the opening (hiatus) in the diaphragm (cruroplasty). Fix stomach: Sew the stomach (fundus) to the esophagus and diaphragm (gastropexy). Create angle: Recreate the angle of His with sutures
a minimally invasive keyhole surgery that treats severe acid reflux (GERD) by wrapping the upper part of the stomach (fundus) around the lower esophagus to create a stronger valve, preventing stomach acid from traveling up. Performed through small incisions, it's a more permanent solution than medication, often used when lifestyle changes and drugs fail, and involves a quicker recovery than traditional open surgery. How it works Reinforces the valve: The stomach's fundus is wrapped around the esophagus, strengthening the natural anti-reflux barrier. Stops acid flow: This "wrap" stops stomach acid and enzymes from splashing back into the esophagus. Corrects hiatal hernia: If present, a hiatal hernia (when part of the stomach pushes through the diaphragm) is also repaired during the procedure.
Degree of relief of GERD symptoms assessed by GERD Health-Related Quality Of Life (GERD-HRQL) score
The GERD-HRQL questionnaire was developed and validated to measure changes of typical GERD symptoms such as heartburn and regurgitation in response to surgical or medical treatment. Total Score: Calculated by summing the individual scores to 15 questions \* Greatest possible score (worst symptoms) = 75 \* Lowest possible score (no symptoms) = 0 Heartburn Score: Calculated by summing the individual scores to 6 questions \* Worst heartburn symptoms = 30 \* No heartburn symptoms = 0 \* Scores less than or equal to 12 with each individual question not exceeding 2 indicate heartburn elimination. Regurgitation Score: Calculated by summing the individual scores to 6 questions . \*Worst regurgitation symptoms = 30 \* No regurgitation = 0 \* Scores less than or equal to 12 with each individual question not exceeding 2 indicate regurgitation.
Time frame: 6 months postoperatively
Plan to share: Undecided
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