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Cost-Effectiveness and Outcome of Robot-assisted Vs Laparoscopic Roux-en-Y Gastric Bypass

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07153419
Acronym
LvRRYGB
Enrollment
512
Registered
2025-09-04
Start date
2026-01-31
Completion date
2028-10-31
Last updated
2025-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Morbid Obesity

Brief summary

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

DEVICELaparoscopic and robotic (DaVinci) RYGB

Laparoscopic and robotic (DaVinci) Roux-en-Y Gastric Bypass

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Early complications rate30 Days after hospital dischargeThe percentage or proportion of individuals who experience adverse events or negative outcomes within a 30th day of time after hospital discharge

Secondary

MeasureTime frameDescription
Conversions rateFrom the beginning to the end of the surgical procedureThe percentage of individuals who start out undergoing a minimally invasive procedure but end up requiring a conversion to a more invasive procedure.
mortality rate30 days after hospital dischargeThe percentage or proportion of individuals who die within a 30th day of time after hospital discharge
Intraoperative complications rateFrom the beginning to the end of the surgical procedureThe percentage or proportion of individuals who experience adverse events or negative outcomes during surgical procedure.
Length of hospital stayup to 1 weekThe amount of time a patient spends in the hospital or medical facility after a surgical procedure has been performed.
Costs of hospitalization and surgeryup to 1 weekthe expenses associated with medical care provided during a patient's stay in a hospital or medical facility, including surgical procedures.
Operative timeFrom the beginning to the end of the surgical procedureThe 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

Countries

Italy

Contacts

Primary ContactFrancesco Pennestrì, Dr.
francesco.pennestri@policlinicogemelli.it+393280244528
Backup ContactMarco Raffaelli, Prof.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026