Laparoscopic Nissen Versus Toupet Fundoplication for Hiatal Hernia.

Laparoscopic Nissen Versus Toupet Fundoplication for Gastroesophageal Reflux Management in Patients With Hiatal Hernia: A Patient- and Assessor-Blinded Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Hiatal Hernia Large; Hiatal Hernia, Paraesophageal; Hiatal Hernia With Gastroesophageal Reflux Disease
• Intervention / Treatment: Procedure: Laparoscopic Nissen Fundoplication; Procedure: Laparoscopic Toupet Fundoplication

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Katya T. Todorova, PhD; Phone Number: +359884744833; Email: katya.todorowa@gmail.com
• Study Contact Backup: Name: Teodor D. Atanasov, Assoc. Prof.; Phone Number: +359899802612; Email: teodor.atanassov@gmail.com

Study Locations

• Bulgaria
  • Sofia-Grad
    • Sofia, Sofia-Grad, Bulgaria, 1517
      • Recruiting
      • UMHAT Sofiamed
      • Contact: Katya T. Todorova, PhD; Phone Number: 0884744833; Email: katya.todorowa@gmail.com
      • Contact: Email: teodor.atanassov@gmail.com
      • Principal Investigator: Teodor D Atanasov, Assoc. prof.
      • Principal Investigator: Katya T Todorova
      • Sub-Investigator: Alexander I Tsvetanov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients aged 18 to 90 years
• Patients diagnosed with primary hiatal hernia by fibrogastroscopy and/or barium swallow examination
• Patients with symptoms of gastroesophageal reflux disease
• Patients scheduled for elective laparoscopic hiatal hernia repair with fundoplication
• Patients able to provide informed consent

Exclusion Criteria:

Patients younger than 18 years or older than 90 years Patients with recurrent hiatal hernia Patients who are not suitable for general anesthesia Patients who prefer a surgical approach other than laparoscopic surgery Patients who are unable or unwilling to provide informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Nissen fundoplication; Participants assigned to this arm will undergo laparoscopic hiatal hernia repair with Nissen fundoplication. The procedure includes a complete 360° fundoplication performed as part of standard laparoscopic antireflux surgery.	Procedure: Laparoscopic Nissen Fundoplication; The procedure includes a complete 360° fundoplication performed as part of standard laparoscopic antireflux surgery.
Active Comparator: Toupet Fundoplication; Participants assigned to this arm will undergo laparoscopic hiatal hernia repair with Toupet fundoplication. The procedure includes a partial posterior 270° 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain score at 24 hours	Postoperative pain will be assessed 24 hours after surgery using the Visual Analog Scale. The score will be used to compare early postoperative pain between participants undergoing laparoscopic Nissen fundoplication and those undergoing laparoscopic Toupet fundoplication.	24 hours after surgery
Postoperative Pain Score at 7 Days	Postoperative pain will be assessed 7 days after surgery using the Visual Analog Scale. The score will be used to evaluate and compare short-term postoperative pain between the two intervention groups.	7 days after surgery
Change in Health-Related Quality of Life After Surgery	Health-related quality of life will be assessed using the GERD-Health Related Quality of Life questionnaire. Preoperative scores will be compared with postoperative scores in order to evaluate changes in reflux-related symptoms and quality of life after laparoscopic Nissen or Toupet fundoplication.	Preoperatively, 1 week, 4 weeks
Postoperative Hospital Stay	Postoperative hospital stay will be measured as the number of days from the day of surgery until hospital discharge. The duration of hospital stay will be compared between the Nissen and Toupet fundoplication groups.	From the day of surgery until hospital discharge - up to 30days
Recurrence of Gastroesophageal Reflux Symptoms	Recurrence of gastroesophageal reflux symptoms will be assessed during postoperative follow-up. The presence or absence of recurrent reflux symptoms will be recorded and compared between the two intervention groups.	4 weeks and 1 year after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operative Timе	Operative time will be measured in minutes from the beginning to the end of the laparoscopic surgical procedure. Total operative time will be compared between participants undergoing Nissen fundoplication and those undergoing Toupet fundoplication.	Intraoperative
Fundoplication Time	Fundoplication time will be measured in minutes as the time required to perform the fundoplication component of the procedure. This measure will be used to compare the technical duration of Nissen and Toupet fundoplication.	Intraoperative
Gas-Bloat Symptoms	Postoperative gas-bloat symptoms will be assessed during follow-up. The presence or absence of symptoms such as bloating, inability to belch, or increased abdominal gas-related discomfort will be recorded and compared between the two groups.	3 days; 1 week
Postoperative Complications	Postoperative complications will be recorded according to type and frequency. The number and nature of postoperative complications will be compared between the Nissen and Toupet fundoplication groups.	Up to 30 days after surgery

Collaborators and Investigators

• Sponsor: Sofia Med Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 29, 2023
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): January 31, 2027

Study Registration Dates

• First Submitted: June 19, 2026
• First Submitted That Met QC Criteria: July 17, 2026
• First Posted (Actual): July 22, 2026

Study Record Updates

• Last Update Posted (Actual): July 22, 2026
• Last Update Submitted That Met QC Criteria: July 17, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Gastroesophageal reflux disease; Hiatal hernia; Antireflux surgery; Laparoscopic fundoplication; Toupet fundoplication
• Additional Relevant MeSH Terms: Internal Hernia; Pathological Conditions, Anatomical; Digestive System Diseases; Gastrointestinal Diseases; Esophageal Diseases; Hernia; Hernia, Diaphragmatic; Esophageal Motility Disorders; Deglutition Disorders; Pathological Conditions, Signs and Symptoms; Hernia, Hiatal; Gastroesophageal Reflux
• Other Study ID Numbers: 25/2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No