Clinical trial

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

Recruiting now · Not applicable · 1 countries · Registry ID NCT05330910

Recruiting nowNot applicableInterventional

What this study 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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age21 Years to 65 Years

SexAll

Healthy volunteersNot accepted

ConditionObesity, Bariatric Surgery Candidate, Esophagus Injury, Gastroesophageal Reflux

Full registry criteria

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

Treatments and study arms

Laparoscopic sleeve gastrectomy with concomitant hiatal hernia repair arm

Procedure

Surgical technique will be standardized and will be performed by the study team. The bougie size for the LSG will be 40Fr, and a standard 5-port LSG will be performed. Standard protocolized postoperative recovery for all bariatric patients will be employed, including liquid diet with vitamins for the first 2 weeks postoperatively, followed by introduction of solid foods after. A hiatal dissection will also be performed during initial surgery, followed by a cruroplasty with Ethibon 0 sutures, in an interrupted manner.