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Laparoscopic Nissen Versus Toupet Fundoplication for Hiatal Hernia.

NCT07718828 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-07-22

No results posted yet for this study

Summary

This randomized controlled trial compares laparoscopic Nissen fundoplication and laparoscopic Toupet fundoplication in patients undergoing surgical treatment for hiatal hernia associated with gastroesophageal reflux disease. Participants will be randomly assigned to one of two surgical groups. The study will evaluate postoperative pain, health-related quality of life, hospital stay, recurrence of reflux symptoms, gas-bloat symptoms, operative time, fundoplication time, and postoperative complications.

Conditions

  • Hiatal Hernia, Paraesophageal
  • Hiatal Hernia Large
  • Hiatal Hernia With Gastroesophageal Reflux Disease

Interventions

PROCEDURE

Laparoscopic Nissen Fundoplication

The procedure includes a complete 360° fundoplication performed as part of standard laparoscopic antireflux surgery.

PROCEDURE

Laparoscopic Toupet Fundoplication

The procedure includes a partial posterior 270° fundoplication performed as part of standard laparoscopic antireflux surgery.

Sponsors & Collaborators

  • Sofia Med Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-29
Primary Completion
2026-07-30
Completion
2027-01-31

Countries

  • Bulgaria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07718828 on ClinicalTrials.gov