Laparoscopic Nissen vs Toupet fundoplication for hiatal hernia with reflux

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized trial compares two laparoscopic anti-reflux surgeries—Nissen and Toupet fundoplication—in adults with primary hiatal hernia and gastroesophageal reflux symptoms. Participants are assigned to one of the two surgical approaches and outcomes such as postoperative pain, quality of life, hospital stay, reflux recurrence, gas-bloat symptoms, operative times, and complications are tracked. The study uses standard elective laparoscopic hiatal hernia repair with fundoplication and follows patients through postoperative recovery to assess relative benefits and risks. No details are provided about long-term follow-up beyond the immediate postoperative and short-term outcomes. The trial is conducted at Sofia Med Hospital in Sofia, Bulgaria, with a single lead sponsor and no listed collaborators.

Why it matters

Who can join: the full rules

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

Where it's running

• UMHAT Sofiamed
  Sofia, Sofia-Grad, Bulgaria Recruiting

Study contacts

• Study coordinator: Katya T. Todorova, PhD
• Email: katya.todorowa@gmail.com
• Phone: +359884744833

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.