Comparison of Laparoscopic Nissen Fundoplication and Hill-Snow Repair for Hiatus Hernia With Endoscopic Evaluation
NCT07387042 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2026-02-04
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
Conditions
- Hiatal Hernia With Gastroesophageal Reflux Disease
Interventions
- PROCEDURE
-
Laparoscopic Hill-Snow repair
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
- PROCEDURE
-
Laparoscopic Nissen Fundoplication
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.
Sponsors & Collaborators
-
Minia University
lead OTHER
Principal Investigators
-
Alaa A El sayed · Minia University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Max Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-03-31
- Primary Completion
- 2027-07-31
- Completion
- 2027-10-31
Countries
- Egypt
Study Locations
More Related Trials
-
Laparoscopic Nissen Fundoplication Comparing Division Versus Non-Division of Short Gastric Vessels
NCT00852098 ·Status: COMPLETED ·Phase: NA
-
Partial Versus Total Fundoplication in the Surgical Repair of Para-esophageal Hernia.
NCT04436159 ·Status: COMPLETED ·Phase: NA
-
Laparoscopic Total vs Partial Fundoplication in Patients With Atypical Symptoms of Gastroesophageal Reflux Disease
NCT05647668 ·Status: COMPLETED ·Phase: NA
-
Valvuloplasty as Alternative to Toupet Fundoplication for GERD
NCT02625077 ·Status: WITHDRAWN ·Phase: NA
-
Clinical Trial Comparing Open and Laparoscopic Nissen Fundoplication in Children
NCT00382850 ·Status: COMPLETED ·Phase: NA
-
Management of Obese Patients With Gastroesophageal Reflux Disease .
NCT06599489 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Complications of Laparoscopic Hiatal Hernia Repair Complicated by Gastroesophageal Reflux Disease Using the ERAS Protocol
NCT07138235 ·Status: COMPLETED
-
Laparoscopic Nissen Versus Toupet Fundoplication: Objective and Subjective Results of a Prospective Randomized Trial
NCT01321294 ·Status: COMPLETED ·Phase: NA
-
Laparoscopic Dor Versus Toupet Fundoplication for the Treatment of Idiopathic Esophageal Achalasia
NCT00490750 ·Status: COMPLETED ·Phase: NA
-
Necessity of Esophageal Dissection During Laparoscopic Fundoplication
NCT00287612 ·Status: COMPLETED ·Phase: NA
-
Evaluation of the Effectiveness of the Ezisurg Stapling (Ezi Endo Lite) During Laparoscopic Nissen Sleeve Gastrectomy
NCT07344935 ·Status: COMPLETED ·Phase: NA
-
A Prospective Randomized Trial Comparing Laparoscopic Nissen Against Anterior Partial Fundoplication in Treating Gastroesophageal Reflux Disease Among Chinese Patients
NCT00480285 ·Status: UNKNOWN ·Phase: PHASE3
-
True Short Esophagus in Gastroesophageal Reflux Disease
NCT03848494 ·Status: COMPLETED
-
Quality of Life Results After Laparoscopic Fundoplication.
NCT04237038 ·Status: COMPLETED ·Phase: NA
-
Assessing Outcomes After Surgery for Gastroesophageal Reflux Disorder
NCT00518505 ·Status: UNKNOWN ·Phase: NA
-
The Effects of Pharyngeal Packing on the Postoperative Gastric Fluid Volume in Patients Undergoing Functional Endoscopic Nasal Surgery
NCT06957275 ·Status: COMPLETED ·Phase: NA
-
Laparoscopic Nissen Versus Anterior Partial Fundoplication
NCT01669330 ·Status: COMPLETED ·Phase: NA
-
Fundoplication in Laparoscopic PEH Repair Based on FLIP
NCT05807763 ·Status: ENROLLING_BY_INVITATION ·Phase: NA
-
Prospective Randomized Trial Evaluating the Utility of Esophageal Stitches During Laparoscopic Fundoplication
NCT01509352 ·Status: COMPLETED ·Phase: NA
-
Laparoscopic Sleeve Gastrectomy and Gastroesophageal Acid Reflux
NCT02012894 ·Status: COMPLETED
-
Short Esophagus in Type II-IV Hiatus Hernia
NCT01587859 ·Status: COMPLETED
-
Comparative Research Between Swenson and Soave Operations for Pediatric Patients Who Have Hirschsprung Disease
NCT07410286 ·Status: COMPLETED ·Phase: NA
-
Esophageal Calibration During Laparoscopic Fundoplication Reduces Dysphagia
NCT01501071 ·Status: COMPLETED ·Phase: NA
-
Can EndoFLIP Improve Quality of Life Before and After Fundoplication?
NCT06159972 ·Status: RECRUITING ·Phase: NA
-
A Prospective Study Comparing Two Reconstructive Operation Techniques After Myotomy of Achalasia
NCT01933373 ·Status: COMPLETED ·Phase: NA