Comparison of Laparoscopic Nissen Fundoplication and Hill-Snow Repair for Hiatus Hernia With Endoscopic Evaluation: Randomized Controlled Trial
| Registry | NCT07387042 |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, treatment |
| Enrollment | 40 (Estimated) |
| Sponsor | Minia University (Other) |
| Conditions | Hiatal Hernia With Gastroesophageal Reflux Disease |
| Interventions | Laparoscopic Hill-Snow repair, Laparoscopic Nissen Fundoplication (Procedure) |
| Dates | start 2026-03-01 (estimated), primary completion 2027-07-01 (estimated), completion 2027-10-01 (estimated), first posted 2026-02-04, last updated 2026-02-04 |
| Locations | 1 site in Egypt |
Related Papers Related Patents Related Grants Related Experts
All trials for Hiatal Hernia With Gastroesophageal Reflux Disease All trials of Laparoscopic Hill-Snow repair All trials of Laparoscopic Nissen Fundoplication
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
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Laparoscopic Hill-Snow repair | Experimental | Procedure: Laparoscopic Hill-Snow repair | |
| Laparoscopic Nissen Fundoplication | Active comparator | Procedure: Laparoscopic Nissen Fundoplication |
Sex: All, ages: any to 18 Years
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Pediatrics and Pediatric Surgery University Hospital, Faculty Of Medicine, Minia Universty | Minya | Egypt |