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)

NCT06021873 | Not Yet Recruiting

• 1 other identifier: 5538
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity, Morbid

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  30 days

Secondary Outcomes (1)

• Evaluation of morbidity, mortality and cost-analysis

  30 days

Study Arms (2)

Laparoscopic SADI-S

ACTIVE COMPARATOR

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

Procedure: SADI-S

Robotic SADI-S

ACTIVE COMPARATOR

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

Procedure: SADI-S

Interventions

SADI-S PROCEDURE

Single-anastomosis duodeno-ileal bypass with sleeve gastrectomy

Laparoscopic SADI-S; Robotic SADI-S

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients eligible for different bariatric procedures than SADI-S

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, 00168, Italy

Location

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Marco Raffaelli, Prof

  Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesco Pennestrì, Dr

CONTACT

+393280244528; francesco.pennestri@policlinicogemelli.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Monocentric, interventional, prospective, randomized 1:1, with comparison of two surgical approaches
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2023
• First Posted: September 1, 2023
• Study Start: January 1, 2024
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: September 1, 2023

Record last verified: 2023-05

Locations

IT (1)