A Randomized Study of Robotic Versus Laparoscopic Techniques for Revisional Bariatric Surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Readmission
研究概览
简要总结
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.
详细描述
Revisional bariatric surgery is becoming increasingly commonplace in surgical practices. Approximately 10-25% of patients bariatric surgery will require a revisional procedure at some point after their initial operation. A conversion from one procedure to another can take place as part of a planned two-step procedure or due to failed weight loss or weight regain after the initial procedure. Furthermore, patients can require revision due to other acute and chronic complications such as marginal ulcers, stenosis and nausea/vomiting. Though these procedures are generally successful in their intended goal, it is been reported that complication rates are higher after revision surgery the primary bariatric procedures. Despite this, few studies have explored methods of increasing safety for revisional bariatric surgery.
Robotic surgery is a tool that could potentially aid in the safety of revisional bariatric surgery. Specific to bariatric surgery, the major strengths of robotic surgery is in facilitating more complex surgical steps, such as a hand-sewn gastrojejunostomy, and providing superior imaging and freedom of movement compared to traditional laparoscopy. While these advantages may not confer major benefits in primary bariatric surgery, revisional bariatric surgery often requires hand-sewn anastomoses in anatomical locations made more difficult by previous surgical scarring and altered anatomy. This may also translate into a long-term clinical and economic benefit which could offset the costs of robotics.
Despite this potential, there have been relatively few studies that have investigated the use of robotic assistance during revisional bariatric surgery and almost none with long-term data. Furthermore, there is a paucity of high-quality research demonstrating any intervention that increases safety during revisional bariatric surgery, including robotics. Considering the current and future demand revisional bariatric surgery, there is a large potential role for any interventions that can increase safety during these operations.
Aim:
The aim of our study is to prospectively evaluate the difference between robotic and laparoscopic revisional bariatric surgery in major surgical outcomes and metabolic outcomes, where applicable.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Once consent has been signed, the patient will be assigned to any of the two groups, using a computer-based randomization on REDCap and the patient will be assigned to the corresponding study arm.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Readmission
时间窗: 30 days from surgery
Readmission to the center within 30 days of the original procedure
Long-term reintervention
时间窗: 5 years
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.
Short term complication rate
时间窗: 30 days from surgery
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\)
次要结局
- BMI change (in kg/m2)(1, 3 and 5 years)
- Weight loss in kgs(1, 3, 5 years)
- Diabetes resolution(1, 3 and 5 years)
- Hypertension resolution(1, 3, and 5 years)
- Sleep apnea resolution(1, 3, and 5 years)