NCT07718828 Laparoscopic Nissen Versus Toupet Fundoplication for Hiatal Hernia.
| NCT ID | NCT07718828 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sofia Med Hospital |
| Condition | Hiatal Hernia, Paraesophageal |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2023-05-29 |
| Primary Completion | 2026-07-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2023-05-29 with a primary completion date of 2026-07-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07718828 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Hiatal Hernia, Paraesophageal. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07718828 currently recruiting?
Yes, NCT07718828 is actively recruiting participants. Contact the research team at katya.todorowa@gmail.com for enrollment information.
Where is the NCT07718828 trial being conducted?
This trial is being conducted at Sofia, Bulgaria.
Who is sponsoring the NCT07718828 clinical trial?
NCT07718828 is sponsored by Sofia Med Hospital. The trial plans to enroll 200 participants.