Laparoscopic Nissen Versus Toupet Fundoplication for Hiatal Hernia.

NCT07718828 | Recruiting

• 1 other identifier: 25/2023
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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 With Gastroesophageal Reflux Disease; Hiatal Hernia, Paraesophageal; Hiatal Hernia Large

Keywords

Hiatal hernia; Gastroesophageal reflux disease; Laparoscopic fundoplication; Toupet fundoplication; Antireflux surgery

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (4)

• Operative Timе

  Intraoperative

• Fundoplication Time

  Intraoperative

• Gas-Bloat Symptoms

  3 days; 1 week

• Postoperative Complications

  Up to 30 days after surgery

Study Arms (2)

Nissen fundoplication

ACTIVE COMPARATOR

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

Toupet Fundoplication

ACTIVE COMPARATOR

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

Interventions

Laparoscopic Nissen Fundoplication PROCEDURE

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

Nissen fundoplication

Laparoscopic Toupet Fundoplication PROCEDURE

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

Toupet Fundoplication

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sofia Med Hospital: lead

Study Sites (1)

UMHAT Sofiamed

Sofia, Sofia-Grad, 1517, Bulgaria

RECRUITING

MeSH Terms

Conditions

Hernia, Hiatal; Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Hernia, Diaphragmatic; Internal Hernia; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Central Study Contacts

Katya T. Todorova, PhD

CONTACT

+359884744833; katya.todorowa@gmail.com

Teodor D. Atanasov, Assoc. Prof.

CONTACT

+359899802612; teodor.atanassov@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and the postoperative outcomes assessor will be masked to the type of fundoplication performed. The operating surgeon and operating room staff cannot be masked due to the nature of the surgical intervention. Operative details regarding the type of fundoplication will not be disclosed to the participant or the outcomes assessor before postoperative assessments are completed.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: Participants will be randomly assigned in a 1:1 ratio to one of two parallel intervention groups. One group will undergo laparoscopic hiatal hernia repair with Nissen fundoplication, and the other group will undergo laparoscopic hiatal hernia repair with Toupet fundoplication. Outcomes will be compared between the two groups at predefined postoperative follow-up time points.

Study Record Dates

• First Submitted: June 19, 2026
• First Posted: July 22, 2026
• Study Start: May 29, 2023
• Primary Completion: July 30, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: July 22, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

BU (1)