MedTrace Logo

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

NCT04861961 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 186

Last updated 2023-12-29

No results posted yet for this study

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

Interventions

PROCEDURE

DS vs. SADI-S vs. OAGBP

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

Sponsors & Collaborators

  • Hospital Universitari de Bellvitge

    lead OTHER

Principal Investigators

  • Javier Osorio · Hospital Universitari de Bellvitge

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-06
Primary Completion
2023-11-06
Completion
2023-11-06

Countries

  • Spain

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04861961 on ClinicalTrials.gov