Status:
COMPLETED
Comparative Analysis of Postoperative Manometry Outcomes in Nissen vs Toupet Fundoplication
Lead Sponsor:
Ain Shams University
Conditions:
GERD - Gastro-Esophageal Reflux Disease
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
This randomized controlled trial investigates the effects of laparoscopic Nissen and Toupet fundoplication on postoperative esophageal manometry findings in patients with gastroesophageal reflux disea...
Detailed Description
Preoperative Setting: Before surgery, all patients underwent a thorough clinical assessment to evaluate the severity of their GERD symptoms, history of medication use, and the presence of extra-esoph...
Eligibility Criteria
Inclusion
- Adult patients between 18 and 65 years of age
- Patients with pre-operable low LES pressure proven by High resolution manometry.
- Patients refractory to medical therapy: Persistent symptoms after 12 weeks of maximal medical therapies, recurrence upon cessation of medications.
- Patients who are non-compliance with medical therapies or inability to tolerate medical therapies .
- Patients with esophageal motility more than 30%
Exclusion
- Patients with esophageal motility less than 30%.
- Patent with morbidly obese (BMI more than 35 kg/m2),
- Patients with recent upper abdominal surgery or severely shortened esophagus
- Extremes of age less than 18 and more than 65.
- Patients who are unfit for general anesthesia (ASAIII,IV or V)..
Key Trial Info
Start Date :
March 10 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 15 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06986902
Start Date
March 10 2024
End Date
March 15 2025
Last Update
May 23 2025
Active Locations (1)
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1
Ain Shams University
Cairo, Egypt, Egypt, 11111