Robotic SurgerySLEEVEROBOPNCT06629662
Robotic Versus Laparoscopic Sleeve Gastrectomy
A study testing Sleeve gastrectomy in people with Robotic Surgery, run by University of Naples at 1 site in Italy.
Trial summary
Sleeve gastrectomy is the most commonly performed bariatric procedures. Robotic surgery seems to add more precision to the surgical interventions. However, robotic bariatric procedures appear to be burdened by longer operative time. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Robotic Surgery
- What is being tested?
- Sleeve gastrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2024to 1 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- According to IFSO (International Federation for the Surgery of Obesity)/ASMBS (American Society for Metabolic and Bariatric Surgery) 2023 guidelines
Who cannot join
- Previous bariatric or abdominal surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Robotic Versus Laparoscopic Sleeve Gastrectomy: Prospective Randomized Study.
Sleeve gastrectomy is the most commonly performed bariatric procedures. Robotic surgery seems to add more precision to the surgical interventions. However, robotic bariatric procedures appear to be burdened by longer operative time.
Aim of the investigators is to prospectively and randomly submit patients suffering from obesity to robotic or laparoscopic surgery in order to compare outcomes.
- Conditions
- Robotic Surgery
- Being tested
- Sleeve gastrectomy
- Keywords
- Robotic surgery, Sleeve Gastrectomy, Bariatric surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleeve gastrectomyProcedure or surgery
Sleeve gastrectomy with laparoscopic or robotic approach
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic sleeve gastrectomy | Active comparator | Patients undergoing traditional sleeve gastrectomy Receives: Procedure: Sleeve gastrectomy |
| Robotic sleeve gastrectomy | Active comparator | Sleeve gastrectomy with DaVinci robot Receives: Procedure: Sleeve gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative time
Operative time in minutes (Docking plus console time for the robotic procedures)
Measured: From the Veress needle insertion at the beginning of the surgical intervention to the last skin stich
Secondary outcomes (8)
Intraoperative bleeding
Bleeding during the surgical procedure
Measured: From the Veress needle insertion at the beginning of the surgical intervention to the last skin stich
Postoperative bleeding
Bleeding after the end of the procedure
Measured: From the end of the procedure to postoperative day 30
Conversion to Laparoscopy
Conversion to laparoscopy
Measured: From the Veress needle insertion at the beginning of the surgical intervention to the last skin stich
Conversion to Laparotomy
Conversion to laparotomy
Measured: From the Veress needle insertion at the beginning of the surgical intervention to the last skin stich
Postoperative Leak
Leak from the staple line
Measured: From the end of the procedure to postoperative day 30
Postoperative Bowel Obstruction
Bowel obstruction
Measured: From the end of the procedure to postoperative day 30
Postoperative nausea
Postoperative nausea measured with a Visuo Analogic Scale (VAS) from 0 (no nausea) to 10 (not tolerable nausea)
Measured: From the end of the procedure to postoperative hour 24
Postoperative vomit
Postoperative vomit measured with a Visuo Analogic Scale (VAS) from 0 (no nausea) to 10 (not tolerable vomit)
Measured: From the end of the procedure to postoperative hour 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start1 Oct 2024
- Primary completion1 Jul 2026
- Study completion1 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Robotic SurgeryStudies 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
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Naples
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Vitiello, University of Naples
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06629662
- Sponsor's protocol ID
- 187/2023
- Acronym
- SLEEVEROBOP
- Status last verified
- Jan 2026
- First submitted
- 3 Oct 2024
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robotic Versus Laparoscopic Sleeve Gastrectomy: Prospective Randomized Study.
- ClinicalTrials.gov ID
- NCT06629662
- Acronym / sponsor ID
- SLEEVEROBOP / 187/2023
- Conditions
- Robotic Surgery
- Keywords
- Robotic surgery, Sleeve Gastrectomy, Bariatric surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University of NaplesUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Jul 2026 (actual)
- Study completion
- 1 Jul 2026 (actual)
- First posted
- 8 Oct 2024 (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.
Sleeve gastrectomy is the most commonly performed bariatric procedures. Robotic surgery seems to add more precision to the surgical interventions. However, robotic bariatric procedures appear to be burdened by longer operative time.
Aim of the investigators is to prospectively and randomly submit patients suffering from obesity to robotic or laparoscopic surgery in order to compare outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic sleeve gastrectomy | Active comparator | Procedure: Sleeve gastrectomyPatients undergoing traditional sleeve gastrectomy |
| Robotic sleeve gastrectomy | Active comparator | Procedure: Sleeve gastrectomySleeve gastrectomy with DaVinci robot |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- According to IFSO (International Federation for the Surgery of Obesity)/ASMBS (American Society for Metabolic and Bariatric Surgery) 2023 guidelines
Key exclusion criteria (1 listed)
- Previous bariatric or abdominal 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 |
|---|---|---|
| Sleeve gastrectomySleeve gastrectomy with laparoscopic or robotic approach | Procedure or surgery | Laparoscopic sleeve gastrectomy, Robotic sleeve gastrectomy |
Primary outcome
Operative time
Time frame: From the Veress needle insertion at the beginning of the surgical intervention to the last skin stich
Operative time in minutes (Docking plus console time for the robotic procedures)
8 secondary outcomes
Intraoperative bleeding
Time frame: From the Veress needle insertion at the beginning of the surgical intervention to the last skin stich
Postoperative bleeding
Time frame: From the end of the procedure to postoperative day 30
Conversion to Laparoscopy
Time frame: From the Veress needle insertion at the beginning of the surgical intervention to the last skin stich
Conversion to Laparotomy
Time frame: From the Veress needle insertion at the beginning of the surgical intervention to the last skin stich
Postoperative Leak
Time frame: From the end of the procedure to postoperative day 30
Postoperative Bowel Obstruction
Time frame: From the end of the procedure to postoperative day 30
Postoperative nausea
Time frame: From the end of the procedure to postoperative hour 24
Postoperative vomit
Time frame: From the end of the procedure to postoperative hour 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Individual participant dataSharing planned: Yes
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleeve gastrectomy in people with Robotic Surgery, run by University of Naples 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 1 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: finished, as of the sponsor's last update on 10 Jul 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operative time (time frame: From the Veress needle insertion at the beginning of the surgical intervention to the last skin stich). 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 10 Jul 2026; AzTrials last refreshed its copy on 30 Oct 2026.