Morbid ObesityLvRRYGBNCT07153419
Cost-Effectiveness and Outcome of Robot-assisted Vs Laparoscopic Roux-en-Y Gastric Bypass
A study testing Laparoscopic and robotic (DaVinci) RYGB in people with Morbid Obesity, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Morbid Obesity
- What is being tested?
- Laparoscopic and robotic (DaVinci) RYGB
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 512 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2026to Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Marco Raffaelli, Prof. contact
Italy1 site
Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, 00168
Marco Raffaelli, +390630154528, marco.raffaelli@policlinicogemelli.it
Marco Raffaelli
About this study
Official title: Cost-Effectiveness and Outcome of Robot-assisted Vs Laparoscopic Roux-en-Y Gastric Bypass: A Non-inferiority Randomized Controlled 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
Read the 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.
- Conditions
- Morbid Obesity
- Being tested
- Laparoscopic and robotic (DaVinci) RYGB
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic and robotic (DaVinci) RYGBDevice
Laparoscopic and robotic (DaVinci) Roux-en-Y Gastric Bypass
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic RYGB | Active comparator | Patients undergoing Roux-en-Y gastric bypass (RYGB) surgery performed laparoscopically. Receives: Device: Laparoscopic and robotic (DaVinci) RYGB |
| Robotic RYGB | Experimental | Patients undergoing Roux-en-Y gastric bypass (RYGB) surgery performed using the DaVinci robotic platform. Receives: Device: Laparoscopic and robotic (DaVinci) RYGB |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 Days after hospital discharge
Secondary outcomes (6)
Intraoperative complications rate
The percentage or proportion of individuals who experience adverse events or negative outcomes during surgical procedure.
Measured: From the beginning to the end of the 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.
Measured: From the beginning to the end of the surgical procedure
mortality rate
The percentage or proportion of individuals who die within a 30th day of time after hospital discharge
Measured: 30 days 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
Measured: From the beginning to the end of the surgical procedure
Length of hospital stay
The amount of time a patient spends in the hospital or medical facility after a surgical procedure has been performed.
Measured: up to 1 week
Costs of hospitalization and surgery
the expenses associated with medical care provided during a patient's stay in a hospital or medical facility, including surgical procedures.
Measured: up to 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study startJan 2026 (estimated)
- Primary completionJul 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 512 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marco Raffaelli, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07153419
- Sponsor's protocol ID
- 5186
- Acronym
- LvRRYGB
- Status last verified
- Sep 2024
- First submitted
- 28 Aug 2023
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost-Effectiveness and Outcome of Robot-assisted Vs Laparoscopic Roux-en-Y Gastric Bypass: A Non-inferiority Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07153419
- Acronym / sponsor ID
- LvRRYGB / 5186
- Conditions
- Morbid Obesity
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 512 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 4 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic RYGB | Active comparator | Device: Laparoscopic and robotic (DaVinci) RYGBPatients undergoing Roux-en-Y gastric bypass (RYGB) surgery performed laparoscopically. |
| Robotic RYGB | Experimental | Device: Laparoscopic and robotic (DaVinci) RYGBPatients undergoing Roux-en-Y gastric bypass (RYGB) surgery performed using the DaVinci robotic platform. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic and robotic (DaVinci) RYGBLaparoscopic and robotic (DaVinci) Roux-en-Y Gastric Bypass | Device | Laparoscopic RYGB, Robotic RYGB |
Primary outcome
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
6 secondary outcomes
Intraoperative complications rate
Time frame: From the beginning to the end of the surgical procedure
Conversions rate
Time frame: From the beginning to the end of the surgical procedure
mortality rate
Time frame: 30 days after hospital discharge
Operative time
Time frame: From the beginning to the end of the surgical procedure
Length of hospital stay
Time frame: up to 1 week
Costs of hospitalization and surgery
Time frame: up to 1 week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marco Raffaelli, Prof. contact
Marco Raffaelli principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic and robotic (DaVinci) RYGB in people with Morbid Obesity, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Francesco Pennestrì, Dr. (+393280244528, francesco.pennestri@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early complications rate (time frame: 30 Days after hospital discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025.