Obesity, MorbidLvRSADISNCT06021873
Evaluation of the Non-inferiority of the Robotic Approach Over the Laparoscopic Approach in Patients Who Are Candidates for Single Anastomosis Duodeno-ileal Bypass With Sleeve Gastrectomy (SADI-S)
A study testing SADI-S in people with Obesity, Morbid, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
Treating patients with super-obesity has always been challenging for bariatric surgeons due to the higher risk of postoperative complications and the limited success of commonly used bariatric procedures (restrictive and hypo-absorptive). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Morbid
- What is being tested?
- SADI-S
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2024to 1 Dec 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Patients eligible for Single-anastomosis duodeno-ileal bypass with sleeve gastrectomy using a minimally invasive technique
- Informed consent
Who cannot join
- Patients eligible for different bariatric procedures than SADI-S
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, 00168
About this study
Treating patients with super-obesity has always been challenging for bariatric surgeons due to the higher risk of postoperative complications and the limited success of commonly used bariatric procedures (restrictive and hypo-absorptive). In this context, these patients are often considered for more complex procedures, such as hypo-absorptive interventions. Over the past 15 years, a new hypo-absorptive procedure called single-anastomosis duodenal switch with biliopancreatic diversion (SADI-S) has been introduced and recognized as a bariatric procedure by leading national and international scientific societies. It has shown promising short- and medium-term results regarding weight loss and metabolic improvements.
The SADI-S procedure is a technically complex multi-quadrant surgery. This study aims to evaluate the equivalence in terms of morbidity between laparoscopic and robotic approaches for patients undergoing this procedure.
Read the detailed description
Patients with super-obesity (BMI≥50 kg/m2) present a significant challenge for bariatric surgeons due to the complexity of their cases. Hypo-absorptive procedures are often necessary to achieve the best results in weight loss and metabolic improvements. However, these procedures are known to be among the most difficult to perform, especially in super-obese patients. In recent years, there has been considerable interest in applying robotic technology to bariatric surgery, specifically for hypo-absorptive procedures.
The single-anastomosis duodenal switch with biliopancreatic diversion (SADI-S) has gained significant attention among the various hypo-absorptive procedures. This procedure is technically less complex than others, thanks to its reconstruction with a single anastomosis between the duodenum and the ileum. Despite its technical advantages, it maintains the original procedure's desired bariatric and metabolic outcomes. SADI-S is now recognized as an established bariatric procedure by major national and international scientific societies.
However, there is ongoing debate regarding the equivalency of laparoscopic and robotic approaches regarding complications, morbidity, and mortality. Thus, this study aims to evaluate the safety and effectiveness of both minimally invasive approaches (laparoscopic and robotic) in patients undergoing SADI-S.
The study will have a monocentric design involving a prospective, interventional, and randomized comparison between the two surgical strategies. The target population includes patients eligible for SADI-S using a minimally invasive technique, with inclusion criteria being age 18 years or older and informed consent. Patients eligible for different bariatric procedures be excluded.
The study will span a duration of 5 years, and the aim is to enroll an average of 105 patients per year to achieve the final sample size. Primary endpoints include comparing the risk of postoperative complications within 30 days of surgery between the laparoscopic and robotic approaches. Secondary endpoints encompass evaluating intraoperative complications, conversion rates, mortality, operative times, and post-operative hospital stay and conducting a cost analysis of both approaches.
However, there is ongoing debate regarding the equivalency of laparoscopic and robotic approaches in terms of complications, morbidity, and mortality. Thus, the objective of this study is to evaluate the safety and effectiveness of both minimally invasive approaches (laparoscopic and robotic) in patients undergoing SADI-S.
The study will have a monocentric design, involving a prospective, interventional, and randomized comparison between the two surgical strategies. The target population includes patients eligible for SADI-S using a minimally invasive technique, with inclusion criteria being age 18 years or older and informed consent. Patients eligible for different bariatric procedures be excluded.
The study will span a duration of 5 years, and the aim is to enroll an average of 105 patients per year to achieve the final sample size. Primary endpoints include comparing the risk of post-operative complications within 30 days of surgery between the laparoscopic and robotic approaches. Secondary endpoints encompass evaluating intraoperative complications, conversion rates, mortality, operative times, post-operative hospital stay, and conducting a cost analysis of both approaches.
- Conditions
- Obesity, Morbid
- Being tested
- SADI-S
- Keywords
- minimally-invasive surgery, robotic surgery, single anastomosis duodeno-ileal bypass with sleeve gastrectomy (sadi-s)
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SADI-SProcedure or surgery
Single-anastomosis duodeno-ileal bypass with sleeve gastrectomy
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic SADI-S | Active comparator | Patients with indication to laparoscopic Single-anastomosis duodeno-ileal bypass with sleeve gastrectomy Receives: Procedure: SADI-S |
| Robotic SADI-S | Active comparator | Patients with indication to robotic Single-anastomosis duodeno-ileal bypass with sleeve gastrectomy Receives: Procedure: SADI-S |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of post-operative complications
Comparison between the laparoscopic and robotic approach to Single-anastomosis duodeno-ileal bypass with sleeve gastrectomy in order to evaluate the post-operative complications rate within 30 days from the surgical procedure. Complications will be expressed in absolute numbers and divided into major complications (grade III-IV) and minor complications (grade I-II) according to the Clavien-Dindo classification.
Measured: 30 days
Secondary outcomes (1)
Evaluation of morbidity, mortality and cost-analysis
Comparison between the laparoscopic and robotic approach to Single-anastomosis duodeno-ileal bypass with sleeve gastrectomy. Our evaluation focuses on: the rate and percentage of intra-operative complications, the conversion rate and percentage, operative time (expressed as 'skin-to-skin' time in minutes), the length of hospital stay (in days), and cost analysis. In Italy, bariatric surgery has a flat reimbursement rate of 5681.3€ regardless of the surgical method (laparoscopic or robotic) or postoperative complications. We will conduct a cost analysis combining bottom-up micro-costing and top-down gross costing. Specifically, operating room costs, which encompass anesthesia, surgery, and scrub nurse professionals, as well as utilities, will be calculated with top-down gross costing. Hospital stay costs will combine micro-costing for drugs and tests with top-down costing for surgical/nurse professionals and accommodation.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2023
- Study start1 Jan 2024 (estimated)
- Primary completion1 Aug 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, MorbidStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marco Raffaelli, Prof, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06021873
- Sponsor's protocol ID
- 5538
- Acronym
- LvRSADIS
- Status last verified
- May 2023
- First submitted
- 10 Jul 2023
- Last updated
- 1 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Non-inferiority of the Robotic Approach Over the Laparoscopic Approach in Patients Who Are Candidates for Single Anastomosis Duodeno-ileal Bypass With Sleeve Gastrectomy (SADI-S)
- ClinicalTrials.gov ID
- NCT06021873
- Acronym / sponsor ID
- LvRSADIS / 5538
- Conditions
- Obesity, Morbid
- Keywords
- minimally-invasive surgery, robotic surgery, single anastomosis duodeno-ileal bypass with sleeve gastrectomy (sadi-s)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 1 Aug 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 1 Sep 2023 (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.
Treating patients with super-obesity has always been challenging for bariatric surgeons due to the higher risk of postoperative complications and the limited success of commonly used bariatric procedures (restrictive and hypo-absorptive). In this context, these patients are often considered for more complex procedures, such as hypo-absorptive interventions. Over the past 15 years, a new hypo-absorptive procedure called single-anastomosis duodenal switch with biliopancreatic diversion (SADI-S) has been introduced and recognized as a bariatric procedure by leading national and international scientific societies. It has shown promising short- and medium-term results regarding weight loss and metabolic improvements.
The SADI-S procedure is a technically complex multi-quadrant surgery. This study aims to evaluate the equivalence in terms of morbidity between laparoscopic and robotic approaches for patients undergoing this procedure.
Detailed description
Patients with super-obesity (BMI≥50 kg/m2) present a significant challenge for bariatric surgeons due to the complexity of their cases. Hypo-absorptive procedures are often necessary to achieve the best results in weight loss and metabolic improvements. However, these procedures are known to be among the most difficult to perform, especially in super-obese patients. In recent years, there has been considerable interest in applying robotic technology to bariatric surgery, specifically for hypo-absorptive procedures.
The single-anastomosis duodenal switch with biliopancreatic diversion (SADI-S) has gained significant attention among the various hypo-absorptive procedures. This procedure is technically less complex than others, thanks to its reconstruction with a single anastomosis between the duodenum and the ileum. Despite its technical advantages, it maintains the original procedure's desired bariatric and metabolic outcomes. SADI-S is now recognized as an established bariatric procedure by major national and international scientific societies.
However, there is ongoing debate regarding the equivalency of laparoscopic and robotic approaches regarding complications, morbidity, and mortality. Thus, this study aims to evaluate the safety and effectiveness of both minimally invasive approaches (laparoscopic and robotic) in patients undergoing SADI-S.
The study will have a monocentric design involving a prospective, interventional, and randomized comparison between the two surgical strategies. The target population includes patients eligible for SADI-S using a minimally invasive technique, with inclusion criteria being age 18 years or older and informed consent. Patients eligible for different bariatric procedures be excluded.
The study will span a duration of 5 years, and the aim is to enroll an average of 105 patients per year to achieve the final sample size. Primary endpoints include comparing the risk of postoperative complications within 30 days of surgery between the laparoscopic and robotic approaches. Secondary endpoints encompass evaluating intraoperative complications, conversion rates, mortality, operative times, and post-operative hospital stay and conducting a cost analysis of both approaches.
However, there is ongoing debate regarding the equivalency of laparoscopic and robotic approaches in terms of complications, morbidity, and mortality. Thus, the objective of this study is to evaluate the safety and effectiveness of both minimally invasive approaches (laparoscopic and robotic) in patients undergoing SADI-S.
The study will have a monocentric design, involving a prospective, interventional, and randomized comparison between the two surgical strategies. The target population includes patients eligible for SADI-S using a minimally invasive technique, with inclusion criteria being age 18 years or older and informed consent. Patients eligible for different bariatric procedures be excluded.
The study will span a duration of 5 years, and the aim is to enroll an average of 105 patients per year to achieve the final sample size. Primary endpoints include comparing the risk of post-operative complications within 30 days of surgery between the laparoscopic and robotic approaches. Secondary endpoints encompass evaluating intraoperative complications, conversion rates, mortality, operative times, post-operative hospital stay, and conducting a cost analysis of both approaches.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic SADI-S | Active comparator | Procedure: SADI-SPatients with indication to laparoscopic Single-anastomosis duodeno-ileal bypass with sleeve gastrectomy |
| Robotic SADI-S | Active comparator | Procedure: SADI-SPatients with indication to robotic Single-anastomosis duodeno-ileal bypass with sleeve gastrectomy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Patients eligible for Single-anastomosis duodeno-ileal bypass with sleeve gastrectomy using a minimally invasive technique
- Informed consent
Key exclusion criteria (1 listed)
- Patients eligible for different bariatric procedures than SADI-S
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 |
|---|---|---|
| SADI-SSingle-anastomosis duodeno-ileal bypass with sleeve gastrectomy | Procedure or surgery | Laparoscopic SADI-S, Robotic SADI-S |
Primary outcome
Evaluation of post-operative complications
Time frame: 30 days
Comparison between the laparoscopic and robotic approach to Single-anastomosis duodeno-ileal bypass with sleeve gastrectomy in order to evaluate the post-operative complications rate within 30 days from the surgical procedure. Complications will be expressed in absolute numbers and divided into major complications (grade III-IV) and minor complications (grade I-II) according to the Clavien-Dindo classification.
1 secondary outcome
Evaluation of morbidity, mortality and cost-analysis
Time frame: 30 days
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 1 Sep 2023.
- Individual participant dataSharing planned: Undecided
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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 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 SADI-S in people with Obesity, Morbid, 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 1 Sep 2023. 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?
Evaluation of post-operative complications (time frame: 30 days). 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 1 Sep 2023.