Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, 00168, Italy
NCT Number: NCT07153419
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
Trial opening soon.
Get Notified18 year–75 year
All sexes
Interventional
Not applicable
Roma, 00168, Italy
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Laparoscopic and robotic (DaVinci) Roux-en-Y Gastric Bypass
Time frame: 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
Time frame: From the beginning to the end of the surgical procedure
The percentage or proportion of individuals who experience adverse events or negative outcomes during surgical procedure.
Time frame: From the beginning to the end of the surgical procedure
The percentage of individuals who start out undergoing a minimally invasive procedure but end up requiring a conversion to a more invasive procedure.
Time frame: 30 days after hospital discharge
The percentage or proportion of individuals who die within a 30th day of time after hospital discharge
Time frame: From the beginning to the end of the surgical procedure
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
Time frame: up to 1 week
The amount of time a patient spends in the hospital or medical facility after a surgical procedure has been performed.
Time frame: up to 1 week
the expenses associated with medical care provided during a patient's stay in a hospital or medical facility, including surgical procedures.
Contact information is provided by the study sponsor or research team.
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Other
Cost-Effectiveness and Outcome of Robot-assisted Vs Laparoscopic Roux-en-Y Gastric Bypass: A Non-inferiority Randomized Controlled Trial
Acronym: LvRRYGB
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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