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)

NCT ID: NCT06021873

Last Updated: 2023-09-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2028-12-01

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Laparoscopic SADI-S

Patients with indication to laparoscopic Single-anastomosis duodeno-ileal bypass with sleeve gastrectomy

Group Type: ACTIVE_COMPARATOR

SADI-S

Intervention Type: PROCEDURE

Single-anastomosis duodeno-ileal bypass with sleeve gastrectomy

Robotic SADI-S

Patients with indication to robotic Single-anastomosis duodeno-ileal bypass with sleeve gastrectomy

Group Type: ACTIVE_COMPARATOR

SADI-S

Intervention Type: PROCEDURE

Single-anastomosis duodeno-ileal bypass with sleeve gastrectomy

Interventions

SADI-S

Single-anastomosis duodeno-ileal bypass with sleeve gastrectomy

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marco Raffaelli, Prof

Role: PRINCIPAL_INVESTIGATOR

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Locations

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, , Italy

Countries

Italy

Central Contacts

Francesco Pennestrì, Dr

Role: CONTACT

francesco.pennestri@policlinicogemelli.it

+393280244528

Other Identifiers

5538

Identifier Type: -

Identifier Source: org_study_id