None listed
Conditions
Brief summary
The laparoscopic gastric sleeve (LSG) operation is an effective bariatric procedure, however, a significant number of patients experience weight regain or insufficient weight loss. In such cases, revisional bariatric operations can be performed in order to improve weight loss, comorbidity resolution and overall quality of life. Many different operations have been proposed for LSG conversion, and currently, the duodenal switch (DS) and the Roux-en-Y gastric bypass (RYGB) are the most popular options. Both operations are safely performed and lead to excellent weight loss and comorbidity resolution. Some studies report that a DS following LSG achieves a higher percentage excess weight loss (%EWL) than the RYGB, however other studies favour the RYGB as a revisional procedure as it is a technically simpler operation and requires less vitamin supplementation to prevent nutritional deficiencies. There a currently no prospective randomized controlled trials comparing these two operations to best inform patients undergoing LSG revision. The primary objective of our study is to compare %EWL after conversion of a LSG to a RYGB, to conversion to a DS at 2 years of follow-up. We also aim to evaluate the resolution of comorbidities (particularly Type 2 Diabetes), post-operative complications and quality of life.
Interventions
Roux en y gastric bypass (RYGB) with silastic ring. Performed laparoscopically with a 150cm biliopancreatic (BP) limb and a 100cm Roux limb. A silastic ring will be applied mid gastric pouch as in standard for RYGB in our unit. The operation usually takes 2 hours to perform. Patients are given ethics approved patient information sheet outlining the operation, risks involved, expected short term and long term outcomes. Patients also attend a 1 hour information seminar delivered by a fellowship tr
Roux en y gastric bypass (RYGB) with silastic ring. Performed laparoscopically with a 150cm biliopancreatic (BP) limb and a 100cm Roux limb. A silastic ring will be applied mid gastric pouch as in standard for RYGB in our unit. The operation usually takes 2 hours to perform. Patients are given ethics approved patient information sheet outlining the operation, risks involved, expected short term and long term outcomes. Patients also attend a 1 hour information seminar delivered by a fellowship trained bariatric surgeon with our specialised bariatric nurse specialists and bariatric dietitians also present to answer questions. 1 hour online dietitian group sessions are performed pre-operatively as well as 1 hour pre-operative bariatric nurse specialist assessment and at least two preoperative 45 minute clinical assessments by the bariatric surgeons. Timing of preoperative appointments relative to surgery varies according to theatre list availability. The intervention is delivered in the operating theatre as a single stage operation by experienced fellowship trained bariatric surgeons.
Sponsors
Waitemata DHB
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
previous sleeve gastrectomy (at least 24 months prior) and Weight greater than 45kg above the ideal body weight for sex, and height. BMI >; 40 by itself or >35 if there is an associated obesity illness , such as diabetes or sleep apnoea Reasonable attempts at other weight loss techniques Age 18-65yrs Obesity related health problems No psychiatric or drug dependency problems A capacity to understand the risks and commitment associated with the surgery. Pregnancy not anticipated in the first two years following surgery
Exclusion criteria
Current smoker Current drug or alcohol abuse Pregnancy Malabsorptive or inflammatory bowel disease Unstable psychiatric disorder History of chronic pancreatitis or idiopathic acute pancreatitis. Severe cardiorespiratory disease or other conditions contraindicating anaesthesia Active malignancy Patients with severe reflux oesophagitis or Barrett’s oesophagus Patients grossly dilated or strictured gastric sleeves
Outcome results
None listed