None listed
Conditions
Brief summary
A new type of procedure for managing obesity has recently become available in Australia: Endoscopic Sleeve Gastroplasty (ESG), which stimulates weight loss by reducing gastric volume. Unlike the widely implemented laparoscopic sleeve gastrectomy (LSG), the less invasive and incisionless ESG is performed endoscopically and trans-orally. Therefore, the ESG will reduce surgery-related complications and recovery time. Therefore, a non-inferiority prospective cohort study will be undertaken to determine the weight loss efficacy, safety, and effect on comorbidity risk factors and quality of life of obese adults receiving Endoscopic Sleeve Gastroplasty (ESG) compared with Laparoscopic Sleeve Gastrectomy (LSG). 106 participants will be consecutively recruited from Weight Loss Solutions Australia on the Gold Coast. The primary outcome will be excess weight loss at 6-months post-procedure, and secondary outcomes will examine body composition (via DXA), quality of life, complications related to the procedure, lipid profile, blood pressure, comorbidities, blood pressure, and allied health use.
Interventions
After consultation with their proceduralist (gastroenterologist or surgeon), participants will select to undergo the ESG or the LSG.
The ESG will be performed as per standard practice by one of the Weight Loss Solutions Australia (WLSA) surgeons. Patients are placed under general anesthesia for the procedure. After measurement of the gastric volume via aesophagogastroduodenoscopy, anterior and posterior suture placement sites are mapped. A cap-based flexible endoscopic suturing system (OverStit
After consultation with their proceduralist (gastroenterologist or surgeon), participants will select to undergo the ESG or the LSG. The ESG will be performed as per standard practice by one of the Weight Loss Solutions Australia (WLSA) surgeons. Patients are placed under general anesthesia for the procedure. After measurement of the gastric volume via aesophagogastroduodenoscopy, anterior and posterior suture placement sites are mapped. A cap-based flexible endoscopic suturing system (OverStitch; Apollo Endosurgery, Austin, TX) is used to perform the procedure. The ESG is created by invaginating the greater curvature of the stomach for formation of the sleeve. The final result is a tubular reconficuration of the gastric lumen. The Laparoscopic Sleeve Gastrectomy (LSG) will be peformed as per standard practice by one of the Weight Loss Solutions Australia (WLSA) surgeons. Patients are placed under general anesthesia for the procedure and local anesthetic is administered at all local trocar entrance sites. The abdominal cavity is accessed via a supraumbilical incision and using a trocar. Two staplers are used commencing at the pylorus up to the incisura angularis. The staple-line is inverted resulting in a gastric sleeve. The patients will be followed from baseline to six-months post-procedure.
Sponsors
Bond University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Plan for ESG or LSG procedure. Aged 18 years or older. Able to provide written informed consent.
Exclusion criteria
Patient reported expected unavailability for face-to-face appointment at 6- and/or 12-months post-procedure.
Outcome results
None listed