Crural Repair During Laparoscopic Sleeve Gastrectomy in Patients With a Lax Gastroesophageal Junction

Recruiting now · Not applicable

Conditions studied: Obesity, Bariatric Surgery Candidate, Esophagus Injury, Gastroesophageal Reflux

In brief

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.

Key facts

Study ID

NCT05330910

Run by

Sengkang General Hospital

People needed

96

Starts

2022-04-01

Expected to finish

2028-04-30

Last updated by the study team

2022-04-15

Who can join

Age: 21 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

• Singapore General Hospital — Singapore, Singapore (enrolling)
• Sengkang General Hospital — Singapore, Singapore (enrolling)

Full record on ClinicalTrials.gov

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