Crural Repair During Laparoscopic Sleeve Gastrectomy in Patients With a Lax Gastroesophageal Junction
Recruiting · NCT05330910 · Interventional (participants receive a specific treatment) · Lead sponsor: Sengkang General Hospital
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
Inclusion criteria
- 21-65 years old
- Able to provide informed consent
- Hill's grade III gastroesophageal junction on preoperative endoscopy
- Opted to undergo laparoscopic sleeve gastrectomy as their bariatric procedure
Exclusion criteria
- Unable or unwilling to provide informed consent
- Contraindications to laparoscopic sleeve gastrectomy
- Opted not to undergo laparoscopic sleeve gastrectomy
- Had previous upper gastrointestinal surgery
- Had documented erosive esophagitis on preoperative endoscopy
- Had Hill's grade I, II or IV gastroesophageal junction on preoperative endoscopy
Where it is running
2 locations listed.
- Singapore General Hospital - Singapore, Singapore
- Sengkang General Hospital - Singapore, Singapore