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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-65
SponsorSengkang General Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Unable or unwilling to provide informed consent

Contraindications to laparoscopic sleeve gastrectomy

Opted not to undergo laparoscopic sleeve gastrectomy

Had previous upper gastrointestinal surgery

Trial design

Treatments tested in this trial

  • Laparoscopic sleeve gastrectomy with concomitant hiatal hernia repair arm
  • Laparoscopic sleeve gastrectomy arm

Treatment groups

96 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Sengkang General Hospital

Lead sponsor

Singapore General Hospital

Collaborator