About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Previous esophageal or gastric surgery
Contraindications to laparoscopy e.g: cardiopulmonary decompensated cases.
Trial design
Parallel
Treatments tested in this trial
Laparoscopic Hill-Snow repair
Procedure/Surgerya 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
Laparoscopic Nissen Fundoplication
Procedure/Surgerya 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Sponsors and contacts
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