Laparoscopic Nissen Versus Toupet Fundoplication for Gastroesophageal Reflux Management in Patients With Hiatal Hernia: A Patient- and Assessor-Blinded Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Postoperative pain score at 24 hours
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Masking Description
Participants and the postoperative outcomes assessor will be masked to the type of fundoplication performed. The operating surgeon and operating room staff cannot be masked due to the nature of the surgical intervention. Operative details regarding the type of fundoplication will not be disclosed to the participant or the outcomes assessor before postoperative assessments are completed.
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Postoperative pain score at 24 hours
Time Frame: 24 hours after surgery
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
Time Frame: 7 days after surgery
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
Time Frame: Preoperatively, 1 week, 4 weeks
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
Time Frame: From the day of surgery until hospital discharge - up to 30days
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.
Recurrence of Gastroesophageal Reflux Symptoms
Time Frame: 4 weeks and 1 year after surgery
Recurrence of gastroesophageal reflux symptoms will be assessed during postoperative follow-up. The presence or absence of recurrent reflux symptoms will be recorded and compared between the two intervention groups.
Secondary Outcomes
- Gas-Bloat Symptoms(3 days; 1 week)
- Operative Timе(Intraoperative)
- Fundoplication Time(Intraoperative)
- Postoperative Complications(Up to 30 days after surgery)
Investigators
Katya Todorova
Doctor
Sofia Med Hospital