NCT04861961: BAR-3

Comparison of Three Hypoabsortive Surgical Techniques for Treatment of Type IV Morbid Obesity

Completed NA Last updated 29 December 2023

What this trial tests

NA trial testing DS vs. SADI-S vs. OAGBP in Bariatric Surgery in 186 participants. Completed in 6 November 2023.

Timeline

6 April 2021

Primary endpoint
6 November 2023

6 November 2023

Quick facts

Lead sponsor	Hospital Universitari de Bellvitge
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	186
Start date	6 April 2021
Primary completion	6 November 2023
Estimated completion	6 November 2023
Sites	1 location across Spain

Drugs / interventions tested

• DS vs. SADI-S vs. OAGBP

Conditions studied

• Bariatric Surgery — all drugs for Bariatric Surgery →
• Morbid Obesity — all drugs for Morbid Obesity →

Sponsor

Hospital Universitari de Bellvitge

Who can join

Adults 18 to 65, any sex, with Bariatric Surgery or Morbid Obesity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Morbid obesity is the first non-traumatic cause of death in the western population and it is also progressively beginning to affect the developing countries. Bariatric surgery provides better results than pharmacological treatments and lifestyle changes, granting a better control of comorbidities.

Duodenal switch (DS) has proben to be the most effective surgical treatment for grade IV morbid obesity and its comorbidities. However, it is not widely used due to its technical complexity and the risk of long-term complications. Single Anastomosis Duodenum-Ileal bypass with Sleeve gastrectomy (SADI-S) was concieved in 2007 as a one-anastomosis simplification of DS, intended to diminish the surgical time and postoperative risks. Recently, another simplified hypo-absorptive technique has started to be widely used: the one anastomosis gastric bypass (OAGBP), also called mini-gastric gypass. It consists of a gastric pouch associated with a gastro-jejunal anastomosis in omega (Billroth II). Despite the potential advantages of these emerging surgical techniques (SADI-S and OAGBP), there is no solid evidence on its efficacy for the treatment of grade IV obesity in comparison with DS. Besides, there is also there is a lack of studies reporting on prospective acid and bile reflux after omega digestive reconstructions, suche as "Billroth II-like" (SADI-S) and "Billroth II" (OAGBP). Bile reflux is potentially premalignant condition.

This prospective randomized study aims to compare conventional DS with SADI-S and OAGBP. We include all morbidly obese patients with BMI ≥ 50 kg/m2 aged 18 years or more. Exclusion criteria are patients who do not fulfill our preoperative bariatric assessment for surgery and those with contraindications for hypo absorptive or mixed surgery.

The main objective of the study is to compare the percentage of excess weight lost at 2 and 5 years after the three different surgical procedures. As a secondary objective, gastroesophageal reflux (GERD) will be compared before and 2 years after surgery, based on GERD symptoms test, gastroscopy and a esophageal pH-impedanciometry in selected patients. Other secondary objectives are comparison of short-term complications, metabolic comorbidities, depositional habit, quality of life and metabolic and nutritional deficiencies at two years of surgery.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.