Laparoscopic Nissen Versus Toupet Fundoplication for Hiatal Hernia. (NCT07718828) | Clinical Trial Compass
RecruitingNot Applicable
Laparoscopic Nissen Versus Toupet Fundoplication for Hiatal Hernia.
Bulgaria200 participantsStarted 2023-05-29
Plain-language 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.
Who can participate
Age range
18 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Postoperative pain score at 24 hours
Timeframe: 24 hours after surgery
2
Postoperative Pain Score at 7 Days
Timeframe: 7 days after surgery
3
Change in Health-Related Quality of Life After Surgery
Timeframe: Preoperatively, 1 week, 4 weeks
4
Postoperative Hospital Stay
Timeframe: From the day of surgery until hospital discharge - up to 30days