Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Gastroesophageal Reflux Disease
  • Hiatal Hernia
  • Morbid Obesity
  • Sleeve Gastrectomy
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 20 years and 65 years
Gender
Both males and females

Description

Patients and methods: A total of 70 patients will be recruited and randomized to two groups with a 1:1 allocation ratio. Patients in the control group receive LSG alone and in the experimental group receive LSG with HHR. All subjects should provide basic clinical and demographic information, be eval...

Patients and methods: A total of 70 patients will be recruited and randomized to two groups with a 1:1 allocation ratio. Patients in the control group receive LSG alone and in the experimental group receive LSG with HHR. All subjects should provide basic clinical and demographic information, be evaluated for GER symptoms using GerdQ score, sign informed consent, and complete preoperative abdominal computed tomography (CT) scan, esophagogastroduodenoscopy (EGD), and HRIM. Outpatient follow-up would be arranged 1 weeks after discharge, then 1 month, 3 months, 6 months, and 12 months after surgery. Weight change and GER symptoms will be evaluated at every outpatient visit. Abdominal CT scan, EGD, and HRIM will be performed 12 months after surgery. Expected results: Less reflux esophagitis, less impedance reflux episodes, lower incidence of hiatal hernia, higher EGJ resting pressure, and longer LES length should be observed in morbidly obese patients receiving LSG with HHR at 12-month follow-up, using EGD and HRIM as evaluation tools. Furthermore, lower GerdQ score should be observed in these patients.

Tracking Information

NCT #
NCT03776669
Collaborators
Not Provided
Investigators
Principal Investigator: PoChu Lee, MD National Taiwan University Hospital