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Laparoscopic Nissen Versus Toupet Fundoplication for Hiatal Hernia.

RecruitingNAAges 18 Years - 90 YearsAllSofia Med Hospital
NCT07718828 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Laparoscopic Nissen Fundoplication
  • Laparoscopic Toupet Fundoplication
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Where

1 site
UMHAT Sofiamed
Sofia, Bulgaria
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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