Actively Recruiting
Crural Repair During Laparoscopic Sleeve Gastrectomy in Patients With a Lax Gastroesophageal Junction
Led by Sengkang General Hospital · Updated on 2022-04-15
96
Participants Needed
2
Research Sites
317 weeks
Total Duration
On this page
Sponsors
S
Sengkang General Hospital
Lead Sponsor
S
Singapore General Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Background: Laparoscopic sleeve gastrectomy (LSG) is one of the commonest bariatric procedures. However, it is associated with postoperative gastroesophageal reflux disease (GERD) and erosive esophagitis (EE). The investigators' preliminary study suggests that the incidence of postoperative GERD and EE appears to be correlated with the preoperative presence of a lax gastroesophageal flap valve and hiatal hernia. Hypothesis/ Aim: To investigate the impact of a concomitant hiatal hernia repair with LSG on the incidence of postoperative EE. Significance: For patients with pre-existing EE, most surgeons will recommend a laparoscopic Roux-en-Y gastric bypass (LRYGB) as their primary bariatric procedure. However, compared to LSG, LRYGB is a technically more demanding procedure with increased morbidity and long term nutritional deficiencies. For asymptomatic patients at risk of postoperative EE due to presence of a hiatal hernia, there is still no consensus on the most appropriate bariatric surgical option. A LSG with a concomitant hiatal hernia repair, if shown to reduce EE postoperatively, may help to expand the pool of patients suitable for LSG in the future. Methods: A two center, double-blinded, randomized controlled trial of all patients, undergoing LSG with a preoperative diagnosis of a Hill's grade III gastroesophageal junction, will be randomized to having a concomitant hiatal hernia repair (experimental arm) versus just LSG alone (control arm). Primary outcome measures include 1-year postoperative EE on endoscopy. Secondary outcome measures include postoperative morbidity, blood loss, quality of life and GERD symptoms at 1-year postoperatively.
CONDITIONS
Official Title
Crural Repair During Laparoscopic Sleeve Gastrectomy in Patients With a Lax Gastroesophageal Junction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 21 to 65 years old
- Able to provide informed consent
- Hill's grade III gastroesophageal junction diagnosed by preoperative endoscopy
- Chosen to undergo laparoscopic sleeve gastrectomy as bariatric surgery
You will not qualify if you...
- Unable or unwilling to provide informed consent
- Contraindications to laparoscopic sleeve gastrectomy
- Chosen not to undergo laparoscopic sleeve gastrectomy
- Previous upper gastrointestinal surgery
- Documented erosive esophagitis on preoperative endoscopy
- Hill's grade I, II, or IV gastroesophageal junction on preoperative endoscopy
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Singapore General Hospital
Singapore, Singapore, 168753
Actively Recruiting
2
Sengkang General Hospital
Singapore, Singapore, 544886
Actively Recruiting
Research Team
K
Koy Min Chue, MBBS, FRCSEd
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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