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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Laparoscopic and robotic (DaVinci) RYGB

    Device

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

Treatment groups

512 Participants
are divided into 2 treatment groups
Group A: Laparoscopic RYGBActive comparator 1 intervention
Group B: Robotic RYGBExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
30 Days after hospital discharge

Secondary outcomes

1

Intraoperative complications rate

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
2

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.

Time frame
From the beginning to the end of the surgical procedure
3

mortality rate

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

Time frame
30 days after hospital discharge
4

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

Time frame
From the beginning to the end of the surgical procedure

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: