UnknownNot Applicable

Robotic Versus Laparoscopic Techniques for Revisional Bariatric Surgery

60 participantsStarted 2019-01-01

Plain-language summary

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.

Who can participate

Age range18 Years – 70 Years

SexALL

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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. se…

What they're measuring

Short term complication rate

Timeframe: 30 days from surgery

Readmission

Timeframe: 30 days from surgery

Long-term reintervention

Timeframe: 5 years

Trial details

NCT IDNCT03673410

SponsorMcMaster University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-07-31

Contact for this trial

Karen Barlow

905-522-1155 kbarlow@stjosham.on.ca