Comparison of Laparoscopic Nissen Fundoplication and Hill-Snow Repair for Hiatus Hernia With Endoscopic Evaluation

NCT07387042 | Not Yet Recruiting DMC

• 1 other identifier: 1799/11/2025
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Hiatus Hernia; Nissen Fundoplication; Hill-Snow repair; Endoscopy

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months postoperatively

Study Arms (2)

Laparoscopic Hill-Snow repair

EXPERIMENTAL

Procedure: Laparoscopic Hill-Snow repair

Laparoscopic Nissen Fundoplication

ACTIVE COMPARATOR

Procedure: Laparoscopic Nissen Fundoplication

Interventions

Laparoscopic Hill-Snow repair PROCEDURE

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

Laparoscopic Hill-Snow repair

Laparoscopic Nissen Fundoplication PROCEDURE

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.

Laparoscopic Nissen Fundoplication

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Previous esophageal or gastric surgery
• Contraindications to laparoscopy e.g: cardiopulmonary decompensated cases.

Sponsors & Collaborators

• Minia University: lead

Study Sites (1)

Pediatrics and Pediatric Surgery University Hospital, Faculty Of Medicine, Minia Universty

Minya, Egypt

Location

Related Publications (7)

• Gyawali, C. P., Kahrilas, P. J., Savarino, E., Zerbib, F., Mion, F., Smout, A. J., ... & Sifrim, D. (2018). Modern diagnosis of GERD: the Lyon Consensus. Gut, 67(7), 1351-1362

  BACKGROUND

• Mönig, S. P., & Hölscher, A. H. (2006). Intraoperative endoscopy. Langenbeck's Archives of Surgery, 391(2), 99-104.

  BACKGROUND

• Spechler, S. J., & Hunter, J. G. (2017). A Modern View of Hiatal Hernia: Lessons from Surgical and Gastroenterologic Literature. Gastroenterology, 153(4), 911-914.

  BACKGROUND

• Hill, L. D., & Snow, L. L. (1999). The Hill-Snow repair for gastroesophageal reflux disease. Surgical Clinics of North America.

  BACKGROUND

• Nissen, R. (1956). Eine einfache Operation zur Beeinflussung der Refluxoesophagitis. Schweiz Med Wochenschr.

  BACKGROUND

• Stefanidis, D., Hope, W. W., Kohn, G. P., Reardon, P. R., Richardson, W. S., & Fanelli, R. D. (2010). Guidelines for surgical treatment of gastroesophageal reflux disease. Surgical Endoscopy, 24(11), 2647-2669.

  BACKGROUND

• Hyun, J. J., & Bak, Y. T. (2011). Clinical Significance of Hiatal Hernia. The Korean Journal of Gastroenterology, 57(3), 160-165.

  BACKGROUND

MeSH Terms

Conditions

Hernia, Hiatal

Condition Hierarchy (Ancestors)

Hernia, Diaphragmatic; Internal Hernia; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Alaa A El sayed

  Minia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed H Hamdy, Master

CONTACT

+201064771480; mhh_raheel92@yahoo.com

Khalaf Y Fathy, MD

CONTACT

+20 11 49113240; Khalafyassen80@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistrent Lecturer

Study Record Dates

• First Submitted: January 28, 2026
• First Posted: February 4, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: February 4, 2026

Record last verified: 2026-01

Locations

EG (1)