Hiatal Hernia, Paraesophageal, Hiatal Hernia Large, Hiatal Hernia With Gastroesophageal Reflux Disease
Conditions
Keywords
Hiatal hernia, Gastroesophageal reflux disease, Laparoscopic fundoplication, Toupet fundoplication, Antireflux surgery
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.
Interventions
PROCEDURELaparoscopic Nissen Fundoplication
The procedure includes a complete 360° fundoplication performed as part of standard laparoscopic antireflux surgery.
PROCEDURELaparoscopic Toupet Fundoplication
The procedure includes a partial posterior 270° fundoplication performed as part of standard laparoscopic antireflux surgery.
Sponsors
Sofia Med Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, 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.
Intervention model description
Participants will be randomly assigned in a 1:1 ratio to one of two parallel intervention groups. One group will undergo laparoscopic hiatal hernia repair with Nissen fundoplication, and the other group will undergo laparoscopic hiatal hernia repair with Toupet fundoplication. Outcomes will be compared between the two groups at predefined postoperative follow-up time points.
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain score at 24 hours | 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 | 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 | 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 | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Operative Timе | Intraoperative | 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 | Intraoperative | 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 | 3 days; 1 week | 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 | Up to 30 days after surgery | 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. |
Countries
Bulgaria
Contacts
CONTACTKatya T. Todorova, PhD
CONTACTTeodor D. Atanasov, Assoc. Prof.
Outcome results
None listed