About this trial
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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Laparoscopic and robotic (DaVinci) RYGB
DeviceLaparoscopic and robotic (DaVinci) Roux-en-Y Gastric Bypass
Treatment groups
Trial outcomes
Primary outcomes
Early complications rate
The percentage or proportion of individuals who experience adverse events or negative outcomes within a 30th day of time after hospital discharge
Secondary outcomes
Intraoperative complications rate
The percentage or proportion of individuals who experience adverse events or negative outcomes during surgical procedure.
Conversions rate
The percentage of individuals who start out undergoing a minimally invasive procedure but end up requiring a conversion to a more invasive procedure.
mortality rate
The percentage or proportion of individuals who die within a 30th day of time after hospital discharge
Operative time
The length of time a patient spends in the operating room undergoing a surgical procedure, from the start of the surgery to the completion of the procedure
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: