Actively Recruiting

Phase Not Applicable
Age: 21Years - 65Years
All Genders
NCT05330910

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

Age: 21Years - 65Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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