Pediatrics and Pediatric Surgery University Hospital, Faculty Of Medicine, Minia Universty
Minya, Egypt
NCT Number: NCT07387042
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
Trial opening soon.
Get NotifiedUp to 18 year
All sexes
Interventional
Not applicable
Minya, Egypt
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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.
Time frame: 6 months postoperatively
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.
Contact information is provided by the study sponsor or research team.
Khalaf Y Fathy, MD
CONTACT
Mohamed H Hamdy, Master
CONTACT
Minia University
Other
Comparison of Laparoscopic Nissen Fundoplication and Hill-Snow Repair for Hiatus Hernia With Endoscopic Evaluation: Randomized Controlled Trial
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