Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07153419

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

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

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, 00168, Italy

Location contact

Marco Raffaelli

CONTACT

[email protected]

+390630154528

Marco Raffaelli

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Laparoscopic and robotic (DaVinci) RYGB

Device

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

Primary outcomes

  1. Early complications rate

    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

Secondary outcomes

  1. Intraoperative complications rate

    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.

  2. Conversions rate

    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.

  3. mortality rate

    Time frame: 30 days after hospital discharge

    The percentage or proportion of individuals who die within a 30th day of time after hospital discharge

  4. Operative time

    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

  5. Length of hospital stay

    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.

  6. Costs of hospitalization and surgery

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Francesco Pennestrì, Dr.

CONTACT

[email protected]

+393280244528

Marco Raffaelli, Prof.

CONTACT

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

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

Acronym: LvRRYGB

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Sep 4, 2025
Registry last updated
Sep 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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.

Published trials that share one or more normalized conditions with this study.