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临床试验/NCT07153419
NCT07153419尚未招募不适用

Cost-Effectiveness and Outcome of Robot-assisted Vs Laparoscopic Roux-en-Y Gastric Bypass: A Non-inferiority Randomized Controlled Trial

Fondazione Policlinico Universitario Agostino Gemelli IRCCS2 个研究点 分布在 1 个国家目标入组 512 人开始时间: 2026年1月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
512
试验地点
2
主要终点
Early complications rate

研究概览

简要总结

The objective of this randomized controlled trial is to compare perioperative outcomes between laparoscopic and robotic approaches in patients with severe obesity who are candidates for RYGB. The trial aims to address the following key questions:

To evaluate the difference between the two procedures in terms of postoperative complications.

To assess intraoperative complications, conversion rate, mortality, operative times, postoperative hospital stay, and cost analysis for both approaches.

In summary, the researchers will compare the laparoscopic and robotic approaches to determine which one leads to better perioperative outcomes

详细描述

Treating patients with pathological obesity has always posed a challenge for bariatric surgeons due to their increased risk of post-operative complications and varying short-term outcomes depending on the chosen procedure. Currently, there are no established guidelines to dictate which procedure is optimal for a given clinical presentation. Surgeons typically make this decision based on their expertise and the patient's characteristics. The most frequently performed procedures worldwide are sleeve gastrectomy and Roux-en-Y gastric bypass, with the latter validated by numerous long-term studies as a safe and effective bariatric and metabolic option for patients with a BMI <50 kg/m2. However, the complexity of Roux-en-Y gastric bypass, which requires the creation of two anastomoses during the reconstruction phase, which might be challenging when performed laparoscopically, may be facilitated by a robotic approach. Although some studies suggest that these approaches have equivalent safety and efficacy profiles, conclusive evidence evaluating their economic impact remains elusive. Consequently, the objective of the present study is to compare morbidity between the laparoscopic and robotic approach in patients undergoing Roux-en-Y gastric bypass.

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
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18 years or older
  • Patients who are candidates for Roux-en-Y gastric bypass using a minimally invasive technique
  • Informed consent has been given.

排除标准

  • patients who are candidates for bariatric procedures other than Roux-en-Y gastric bypass, or to those who require a laparotomy for Roux-en-Y gastric bypass surgery.

结局指标

主要结局

Early complications rate

时间窗: 30 Days after hospital discharge

The percentage or proportion of individuals who experience adverse events or negative outcomes within a 30th day of time after hospital discharge

次要结局

  • Intraoperative complications rate(From the beginning to the end of the surgical procedure)
  • Conversions rate(From the beginning to the end of the surgical procedure)
  • mortality rate(30 days after hospital discharge)
  • Operative time(From the beginning to the end of the surgical procedure)
  • Length of hospital stay(up to 1 week)
  • Costs of hospitalization and surgery(up to 1 week)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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