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

NCT04861961 | Completed

• 1 other identifier: BAR-3
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bariatric Surgery; Morbid Obesity

Keywords

Bariatric Surgery; Morbid Obesity; Hypoabsortive surgery; Duodenal Switch; SADI-S; One-anastomosis gastric by-pass; Gastro-esophageal reflux

Outcome Measures

Primary Outcomes (1)

• Percentage of excess weight lost (% EWL)

  % EWL considering ideal BMI = 25 kg/m2

  At 5 years after surgery

Secondary Outcomes (7)

• Gastroesophageal reflux

  2 years after surgery

• Postoperative complications

  30 days after surgery

• Postoperative mortality

  90 days after surgery

• Metabolic comorbidities

  At 5 years of surgery

• Quality of life (SF-12 test)

  At 2 years of surgery

Study Arms (3)

Laparoscopic duodenal switch (DS)

ACTIVE COMPARATOR

Standard duodenal switch (double anastomoses). Roux-en-Y reconstruction.

Procedure: DS vs. SADI-S vs. OAGBP

Laparoscopic Single Anastomosis Duodenum-Ileal bypass with Sleeve gastrectomy (SADI-S)

ACTIVE COMPARATOR

Simplified duodenal switch with one anastomosis. Duodeno-ileal omega reconstruction ("Billroth II-like").

Procedure: DS vs. SADI-S vs. OAGBP

Laparoscopic one anastomosis gastric bypass (OAGBP)

ACTIVE COMPARATOR

Gastric bypass of one anastomoses. Gastro-jejunal omega reconstruction (Billroth II).

Procedure: DS vs. SADI-S vs. OAGBP

Interventions

DS vs. SADI-S vs. OAGBP PROCEDURE

Randomizacion of candidates for either conventional DS, SADI-S or OAGBP.

Laparoscopic Single Anastomosis Duodenum-Ileal bypass with Sleeve gastrectomy (SADI-S); Laparoscopic duodenal switch (DS); Laparoscopic one anastomosis gastric bypass (OAGBP)

Eligibility Criteria

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

You may qualify if:

• Patients older than 18 and younger than 65 who fulfil bariatric surgery indications
• BMI between 50 and 60 kg / m2
• Patients with a good overall condition to perform a one step surgery
• Signing up of the informed consent for the study
• Patient suitable for laparoscopic surgery

You may not qualify if:

• Previous bariatric surgery
• Two stage surgery
• Medical contraindication for a hypoabsorptive surgery due to previous pathology: inflammatory bowel disease, organ transplantation or candidate for a transplant, previous intestinal resection surgery
• Conversion to laparotomy

Sponsors & Collaborators

• Hospital Universitari de Bellvitge: lead

Study Sites (1)

Hospital Universitary de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Related Publications (3)

• Finno P, Osorio J, Garcia-Ruiz-de-Gordejuela A, Casajoana A, Sorribas M, Admella V, Serrano M, Marchesini JB, Ramos AC, Pujol-Gebelli J. Single Versus Double-Anastomosis Duodenal Switch: Single-Site Comparative Cohort Study in 440 Consecutive Patients. Obes Surg. 2020 Sep;30(9):3309-3316. doi: 10.1007/s11695-020-04566-5.

  PMID: 32240495 BACKGROUND

• Sorribas M, Casajoana A, Sobrino L, Admella V, Osorio J, Pujol-Gebelli J. Experience in biliopancreatic diversion with duodenal switch: results at 2, 5 and 10 years. Cir Esp (Engl Ed). 2021 Feb 13:S0009-739X(21)00030-0. doi: 10.1016/j.ciresp.2021.01.008. Online ahead of print. English, Spanish.

  PMID: 33593597 BACKGROUND

• Admella V, Osorio J, Sorribas M, Sobrino L, Casajoana A, Pujol-Gebelli J. Direct and two-step single anastomosis duodenal switch (SADI-S): Unicentric comparative analysis of 232 cases. Cir Esp (Engl Ed). 2021 Aug-Sep;99(7):514-520. doi: 10.1016/j.cireng.2021.06.017. Epub 2021 Jul 1.

  PMID: 34217637 BACKGROUND

MeSH Terms

Conditions

Obesity, Morbid; Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Javier Osorio

  Hospital Universitari de Bellvitge

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Javier Osorio, MD, PhD

Model Details: Prospective randomized study comparing three bariatric surgical techniques

Study Record Dates

• First Submitted: April 22, 2021
• First Posted: April 27, 2021
• Study Start: April 6, 2021
• Primary Completion: November 6, 2023
• Study Completion: November 6, 2023
• Last Updated: December 29, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: April 2026 to april 2027
• Access Criteria: On demand to PI

Locations

ES (1)