Bariatric Surgery Clinical Trial
Official title:
A Randomized Study of Robotic Versus Laparoscopic Techniques for Revisional Bariatric Surgery
Obesity has become a significant health problem in Canada. When conservative efforts to lose
weight fail, bariatric surgical procedures are often considered. Today, the most common
bariatric procedures in North America are Laparoscopic Roux-en-Y gastric bypass (LRYGB) and
Laparoscopic Sleeve Gastrectomy (LSG).
For many reasons, an initial bariatric procedure may require surgical revision. Some reasons
include weight regain, failed weight loss or other acute and chronic complications not
related to weight loss. In these cases, it may be indicated that a procedure be reversed inor
converted to another type of bariatric procedure. Regardless of the planned intervention,
revisional surgery is always more difficult than the initial procedure mainly due to surgical
scarring and altered anatomy. Though revisional bariatric surgery has been shown to be safe,
our hope is to improve the safety profile by utilizing robotic surgery. Robotic surgery can
facilitate more complex procedures by providing superior imaging and freedom of movement
during the procedure.
The aim of our study is to evaluate prospectively the outcomes of robotic compared to
laparoscopic revisional bariatric surgery in terms of perioperative outcomes such as
complication rates, operative time and readmissions as well as weight loss/comorbidity
resolution (diabetes, hypertension, sleep apnea) where applicable.
Status | Not yet recruiting |
Enrollment | 60 |
Est. completion date | July 31, 2025 |
Est. primary completion date | July 31, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - The subject previously met National Institutes of Health criteria for bariatric surgery11 and received a bariatric surgical procedure. - The subject is under consideration to undergo a revisional bariatric procedure after for failed sustained weight loss, weight regain or other chronic issues requiring revision. - The subject is able and willing to give written consent - The subject must be 18-70 years of age - The subject must be willing and able to participate in the study procedures and to understand and sign the informed consent Exclusion Criteria: - The subject has a contraindication to general anesthesia - The revision does not occur within the first 90 days of the initial bariatric procedure - The subject has any medical condition, which in the judgment of the Investigator and/or designee makes the subject a poor candidate for the investigational procedure - The subject is a pregnant or lactating female (Women of child bearing potential must take a pregnancy test prior to surgery) - The subject has an history of alcohol abuse (>30 g/day in men or >20 g/day in women) - Any subject who is considered to be part of a vulnerable population (e.g. prisoners or those with psychological concerns or those without sufficient mental capacity) - The subject is unable or unwilling to comply with the study requirements or follow-up schedule - The subject has conditions which, in the opinion of the investigator, will not be appropriate for the study (e.g. severe cardiovascular disease, history of gastrointestinal (GI) malignancy, history of upper GI surgery, open cholecystectomy, history of intestinal surgery, immunosuppression, or non-ambulatory) - The subject has an estimated life expectancy of less than 6 months |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
McMaster University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Short term complication rate | Any complication - Complication will be defined by the Clavien-Dindo classification and our primary outcome will be long-term complications higher than grade III. These will include leaks and bleeds. Only complications related to the procedure, such as therapeutic endoscopy or reoperation will be counted. 3) |
30 days from surgery | |
Primary | Readmission | Readmission to the center within 30 days of the original procedure | 30 days from surgery | |
Primary | Long-term reintervention | Reinterventions for chronic surgical complications (such as stricture) will be assessed through the bariatric clinic. Only reintenrtventinos related to the original procedure will be counted. |
5 years | |
Secondary | Weight loss in kgs | This is the change in weight from the date of operation 2) 3) 4) 5) Sleep apnea (binary, defined as no need for CPAP) | 1, 3, 5 years | |
Secondary | BMI change (in kg/m2) | This is the change in BMI from the date of operation | 1, 3 and 5 years | |
Secondary | Diabetes resolution | This is a binary outcome relating to the resolution of diabetes from baseline defined as no need for medication | 1, 3 and 5 years | |
Secondary | Hypertension resolution | This is a binary outcome relating to the resolution of hypertension from baseline defined as no need for medication | 1, 3, and 5 years | |
Secondary | Sleep apnea resolution | This is a binary outcome relating to the resolution of sleep apnea from baseline defined as no need for medication | 1, 3, and 5 years |
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