Laparoscopic Nissen Versus Toupet Fundoplication for Hiatal Hernia.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Laparoscopic Nissen Fundoplication, Laparoscopic Toupet Fundoplication.
- Who it may be relevant to
- Registry conditions: Hiatal Hernia, Paraesophageal, Hiatal Hernia Large, Hiatal Hernia With Gastroesophageal Reflux Disease. Basic parameters: 18 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Bulgaria
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Laparoscopic Nissen Versus Toupet Fundoplication for Gastroesophageal Reflux Management in Patients With Hiatal Hernia: A Patient- and Assessor-Blinded Randomized Controlled Trial
Overview
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.
Interventions
- Procedure Laparoscopic Nissen Fundoplication
The procedure includes a complete 360° fundoplication performed as part of standard laparoscopic antireflux surgery. - Procedure Laparoscopic Toupet Fundoplication
The procedure includes a partial posterior 270° fundoplication performed as part of standard laparoscopic antireflux surgery.
Primary outcome measures
- Postoperative pain score at 24 hours [Time frame: 24 hours after surgery]
- Postoperative Pain Score at 7 Days [Time frame: 7 days after surgery]
- Change in Health-Related Quality of Life After Surgery [Time frame: Preoperatively, 1 week, 4 weeks]
- Postoperative Hospital Stay [Time frame: From the day of surgery until hospital discharge - up to 30days]
- Recurrence of Gastroesophageal Reflux Symptoms [Time frame: 4 weeks and 1 year after surgery]
Secondary outcome measures (4)
- Operative Timе [Time frame: Intraoperative]
- Fundoplication Time [Time frame: Intraoperative]
- Gas-Bloat Symptoms [Time frame: 3 days; 1 week]
- Postoperative Complications [Time frame: Up to 30 days after surgery]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Bulgaria · 1 center
- UMHAT Sofiamed — Sofia
Identifiers
NCT: NCT07718828 · 25/2023