Cost-Effectiveness and Outcome of Robot-assisted Vs Laparoscopic Roux-en-Y Gastric Bypass
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Laparoscopic and robotic (DaVinci) RYGB.
- Who it may be relevant to
- Registry conditions: Morbid Obesity. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Cost-Effectiveness and Outcome of Robot-assisted Vs Laparoscopic Roux-en-Y Gastric Bypass: A Non-inferiority Randomized Controlled Trial
Overview
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
Detailed description
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.
Interventions
- Device Laparoscopic and robotic (DaVinci) RYGB
Laparoscopic and robotic (DaVinci) Roux-en-Y Gastric Bypass
Primary outcome measures
- Early complications rate [Time frame: 30 Days after hospital discharge]
Secondary outcome measures (6)
- Intraoperative complications rate [Time frame: From the beginning to the end of the surgical procedure]
- Conversions rate [Time frame: From the beginning to the end of the surgical procedure]
- mortality rate [Time frame: 30 days after hospital discharge]
- Operative time [Time frame: From the beginning to the end of the surgical procedure]
- Length of hospital stay [Time frame: up to 1 week]
- Costs of hospitalization and surgery [Time frame: up to 1 week]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Italy · 1 center
- Fondazione Policlinico Universitario A. Gemelli IRCCS — Roma
Identifiers
NCT: NCT07153419 · 5186