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.
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
None
Parallel
Laparoscopic Nissen Fundoplication
Procedure/SurgeryThe procedure includes a complete 360° fundoplication performed as part of standard laparoscopic antireflux surgery.
Laparoscopic Toupet Fundoplication
Procedure/SurgeryThe procedure includes a partial posterior 270° fundoplication performed as part of standard laparoscopic antireflux surgery.
Postoperative pain score at 24 hours
Postoperative pain will be assessed 24 hours after surgery using the Visual Analog Scale. The score will be used to compare early postoperative pain between participants undergoing laparoscopic Nissen fundoplication and those undergoing laparoscopic Toupet fundoplication.
Postoperative Pain Score at 7 Days
Postoperative pain will be assessed 7 days after surgery using the Visual Analog Scale. The score will be used to evaluate and compare short-term postoperative pain between the two intervention groups.
Change in Health-Related Quality of Life After Surgery
Health-related quality of life will be assessed using the GERD-Health Related Quality of Life questionnaire. Preoperative scores will be compared with postoperative scores in order to evaluate changes in reflux-related symptoms and quality of life after laparoscopic Nissen or Toupet fundoplication.
Postoperative Hospital Stay
Postoperative hospital stay will be measured as the number of days from the day of surgery until hospital discharge. The duration of hospital stay will be compared between the Nissen and Toupet fundoplication groups.
Operative Timе
Operative time will be measured in minutes from the beginning to the end of the laparoscopic surgical procedure. Total operative time will be compared between participants undergoing Nissen fundoplication and those undergoing Toupet fundoplication.
Fundoplication Time
Fundoplication time will be measured in minutes as the time required to perform the fundoplication component of the procedure. This measure will be used to compare the technical duration of Nissen and Toupet fundoplication.
Gas-Bloat Symptoms
Postoperative gas-bloat symptoms will be assessed during follow-up. The presence or absence of symptoms such as bloating, inability to belch, or increased abdominal gas-related discomfort will be recorded and compared between the two groups.
Postoperative Complications
Postoperative complications will be recorded according to type and frequency. The number and nature of postoperative complications will be compared between the Nissen and Toupet fundoplication groups.
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