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) (LvRSADIS)

• ClinicalTrials.gov Identifier: NCT06021873
• Recruitment Status: Not yet recruiting
• First Posted: September 1, 2023
• Last Update Posted: September 1, 2023
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Information provided by (Responsible Party): Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study Description

Brief 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). 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.

Condition or disease	Intervention/treatment	Phase
Obesity, Morbid	Procedure: SADI-S	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 105 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Masking Description: Monocentric, interventional, prospective, randomized 1:1, with comparison of two surgical approaches
• Primary Purpose: Treatment
• 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)
• Estimated Study Start Date: January 1, 2024
• Estimated Primary Completion Date: August 1, 2028
• Estimated Study Completion Date: December 1, 2028

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Laparoscopic SADI-S; Patients with indication to laparoscopic Single-anastomosis duodeno-ileal bypass with sleeve gastrectomy	Procedure: SADI-S; Single-anastomosis duodeno-ileal bypass with sleeve gastrectomy
Active Comparator: Robotic SADI-S; Patients with indication to robotic Single-anastomosis duodeno-ileal bypass with sleeve gastrectomy	Procedure: SADI-S; Single-anastomosis duodeno-ileal bypass with sleeve gastrectomy

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. Evaluation of morbidity, mortality and cost-analysis [ Time Frame: 30 days ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Age ≥ 18 years
• Patients eligible for Single-anastomosis duodeno-ileal bypass with sleeve gastrectomy using a minimally invasive technique
• Informed consent

Exclusion Criteria:

• Patients eligible for different bariatric procedures than SADI-S

Contacts and Locations

Contacts

Contact: Francesco Pennestrì, Dr; +393280244528; francesco.pennestri@policlinicogemelli.it

Locations

Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, Italy, 00168

Sponsors and Collaborators

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

• Principal Investigator: Marco Raffaelli, Prof; Fondazione Policlinico Universitario Agostino Gemelli IRCCS

More Information

• Responsible Party: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• ClinicalTrials.gov Identifier: NCT06021873
• Other Study ID Numbers: 5538
• First Posted: September 1, 2023
• Last Update Posted: September 1, 2023
• Last Verified: May 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Fondazione Policlinico Universitario Agostino Gemelli IRCCS:

minimally-invasive surgery; robotic surgery; single anastomosis duodeno-ileal bypass with sleeve gastrectomy (sadi-s)

Additional relevant MeSH terms:

Obesity, Morbid; Obesity; Overweight; Overnutrition; Nutrition Disorders; Body Weight