Effect of Routine Anterior Crural Repair in De-Novo Gastroesophageal Reflux After Laparoscopic Sleeve Gastrectomy - A Randomized Control Trial

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The purpose of the study is to evaluate the superiority of anterior crural repair during sleeve gastrectomy over no repair in decreasing the incidence of gastroesophageal reflux disease.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: t
View:

• Subject without previous bariatric procedure and meets IFSO Asia-Pacific Chapter Consensus of Metabolic \& Bariatric surgery criteria:

• i. BMI more than 35 kg/m2 with or without co-morbidities. ii. BMI more than 30 kg/m2 with obesity related co-morbidities.

• Subject without evidence of gastroesophageal reflux disease i. Symptomatic - No gastroesophageal reflux symptom (GerdQ score no greater than 7) ii. Endoscopic - No esophagitis. No Hiatus Hernia (apparent separation distance between the squamocolumnar junction and the diaphragmatic impression greater than 2 cm) iii. Functional

⁃ 1\. High-resolution manometry 2. 24-hour esophageal pH study 4. ASA Class I - III 5. Subject is willing to give consent and comply with evaluation and treatment scheduled

Locations
Other Locations
China
Chinese University of Hong Kong
RECRUITING
Hong Kong
Contact Information
Primary
Enders KW Ng, Professor
endersng@surgery.cuhk.edu.hk
55699241
Backup
Simon KH Wong, Consultant
wongkhmo@surgery.cuhk.edu.hk
55699510
Time Frame
Start Date: 2021-05-01
Estimated Completion Date: 2025-12-30
Participants
Target number of participants: 50
Treatments
Experimental: The study group
The procedure done to this group is Sleeve Gastrectomy with Anterior Crural Repair (ACR)
Other: The control group
The procedure done to this group is the Standard Sleeve Gastrectomy (SSG)
Sponsors
Leads: Chinese University of Hong Kong

This content was sourced from clinicaltrials.gov