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临床试验/NCT05224791
NCT05224791招募中不适用

A Retrospective Multicenter Comparison of Laparoscopic and Robotic-Assisted Roux-en-Y Gastric Bypass and Sleeve Gastrectomy

Methodist Health System1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2020年6月26日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
400
试验地点
1
主要终点
Pre-Operative Information:

研究概览

简要总结

The prevalence of obesity has tripled in the last 50 years with presently about 1.7 billion of the world population aged 18 years and over either overweight or obese.1 In the US alone, 35% of the population is obese.2 Although alternative surgical approaches are available, bariatric surgery results in substantial and durable weight reduction for the majority of patients, making it the most effective treatment for severe obesity.3 In the battle to reduce the invasiveness of bariatric procedures, laparoscopy has become the gold standard approach for virtually all bariatric surgery procedures in the years since it was first used for gastric bypass by Wittgrove and colleagues in 1993.5 Available data shows perioperative patient-oriented advantages of laparoscopy when compared with open surgery, including a shorter hospital stay, decreased postoperative pain, and enhanced postoperative recovery.6 The Agency for Healthcare Research and Quality (AHRQ) reported significant improvements in the safety of metabolic/bariatric surgery due in large part to improved surgical techniques.7 The risk of death is about 0.1%8 and the overall likelihood of major complications is about 4%.9 Performing bariatric surgery laproscopically can be demanding in many situations because of large livers and substantial visceral fat that limit the working space and make exposure, dissection, and reconstruction difficult.10 Similarly, thick abdominal walls may cause excessive torque on instruments. Under such situations, surgeons' ergonomics become a serious concern.11 Use of robotics in bariatric surgery has been evolving since Cadiere and colleagues reported the first case in 1999.12 Robotic surgery has provided the surgeons with the advantage of three-dimensional vision as well as increased dexterity and precision by downscaling surgeon's movements enabling a fine tissue dissection and filtering out physiological tremor.13 It overcomes the restraint of torque on ports from thick abdominal wall, and minimizes port site trauma by remote center technology.14 Although Roux-en-Y gastric bypass (RYGB) is considered by many to be the gold standard procedure for weight loss,4 several studies demonstrate that sleeve gastrectomy (SG) and RYGB provide comparable weight loss.15 In fact, utilization of SG significantly increased from 9.3% in 2010 to 58.2% in 2014.16

详细描述

Procedure Description 1.2.1 Roux-en-Y Gastric Bypass The RYGB connects a limb of the intestine to a much smaller stomach pouch, which prevents the bile from entering the upper part of the stomach and esophagus, thereby effectively bypassing the remaining stomach and first segment of the small intestine. 21 The first step of RYGB involves the creation of the gastric pouch. The angle of His is identified with the fundus retracted laterally. The peritoneum, over the angle of His, is dissected with ultrasonic shears or scissors and carried posterior to identify the path for a linear stapler and the left crus of the diaphragm. Next, the mesentery to the lesser curve of the stomach is divided by a stapler. Once the retrogastric plane in the lesser curve is created, two serial applications of stapler will be used to create a 20 mL gastric pouch. 21 The second step is the creation of jejunojejunostomy. A stapler is utilized to create the anastomosis. The common enterotomy is closed with either a single running layer of 2-0 Vicryl or a second firing stapler. Finally, the gastrojejunal anastomosis is created and the Roux limb is pulled up to the level of the gastric pouch. 21

1.2.2 Sleeve Gastrectomy The SG is a restrictive procedure in which a partial left gastrectomy of the fundus and body of the stomach is performed in order to create a long tubular "sleeve" along the lesser curvature. The weight loss and resolution of comorbidities are attributed not only to the restrictive nature of the procedure but also to restriction by the pylorus, decreased ghrelin, increased satiety, increased gastric emptying, and faster small bowel transit times with a component of malabsorption.17-20

1.2 Aim(s)/Objective(s) The overall aim of this study is to evaluate and compare outcomes associated with robotic-assisted and laparoscopic bariatric surgery.

1.3 Rationale for the Study Studies to date have drawn partial contrasting conclusions when comparing robotic-assisted and laparoscopic bariatric surgery. There is a need to collect more scientific evidence data around the clinical outcomes of bariatric surgery performed with either robotic-assisted or laparoscopic surgery to describe the potential advantages of these techniques.

1.4 Hypothesis 1.4.1 Primary Hypothesis We hypothesize that the RYGB will indicate better outcomes compared to the SG.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subject was 18 years or older at the time of procedure
  • Subject who has undergone either laparoscopic or robotic-assisted RYGB or SG between the time frame of 30 days prior to institution's IRB approval date and the year 2017
  • Subject has one of the below qualifications:
  • Body mass index (BMI) > 40 kg/m2 or more than 100 pounds overweight OR
  • BMI > 35 kg/m2 and one of the following obesity-related co-morbidities such as type II diabetes mellitus, hypertension, sleep apnea and other respiratory disorders, non- alcoholic fatty liver disease, osteoarthritis, lipid abnormalities, gastrointestinal disorders, or heart disease.

排除标准

  • Subject who underwent RYGB or SG as an emergent procedure
  • Subject who underwent RYGB or SG as revisional bariatric procedure
  • Subject who underwent RYGB or SG as a secondary (concomitant) procedure and not as a primary procedure

结局指标

主要结局

Pre-Operative Information:

时间窗: January 1, 2017 -May 2020

Collection of Demographics data: gender, age in years Collection of pre-operative medical history: diabetes status, cardiopulmonary disease, hypertension diagnosis, previous abdominal surgery Collection of Demographics patient characteristics: BMI, ASA Class, tobacco use

Short-Term Follow-Up Data (up to 30 days post-discharge):

时间窗: January 1, 2017 -May 2020

Data collection of events such as Adverse events up to 30 days, re- admissions, re-operations related to the index procedure

Intra-Operative Data:

时间窗: January 1, 2017 -May 2020

Operative time

Post-Operative Data (up to discharge)

时间窗: January 1, 2017 -May 2020

Post-operative data collection such as adverse events, discharge status, hospital length of stay, information on enhanced recovery program

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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