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Completed

NCT Number: NCT03339791

Sleeve Versus Bypass in Older Patients: a Randomized Controlled Trial

The aim of the study is to compare two different bariatric procedures performed in patients with 65 years or more: gastric bypass and sleeve gastrectomy. Primary outcomes will be weight loss, control of comorbidities and morbidity of the operation. Secondary outcomes are related to functionality, that will be evaluated with specific tests.

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Key information

Age range

65 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital das Clinicas da Faculdade de Medicina da USP

São Paulo, 05403-000, Brazil

About this study

Introduction: Surgical treatment of obesity in patients over 65 years of age is controversial. For patients in this age group, there is a prevailing concept that the risk / benefit ratio of the procedure should be evaluated for each individual patient, without determining objective criteria or outcomes that characterize this benefit. Increased surgical risk in patients older than 65 years is undoubtedly a limiting factor for the broader indication of bariatric surgery in this population. The two most applied surgical techniques are Sleeve Gastrectomy and Roux-en-Y Gastric Bypass. Most of the studies that evaluated the two techniques in elderly patients are retrospective, prospective non-randomized, or contemplated only one technique. Recent, studies concluded that in the elderly the weight loss with Gastric Bypass was higher, but the surgical morbidity with the Sleeve was lower and there was no difference in the resolution of comorbidities between the two techniques. In evaluating the benefits of surgery, most studies address outcomes such as weight loss and control of metabolic and cardiovascular comorbidities. Outcomes that are specific to the treatment of obesity in the elderly, such as improvement of functionality, decreased fragility and improvement of the quality of life have not been studied yet. In this field, there is concern that excessive weight loss, accompanied by loss of muscle mass may compromise the mentioned parameters, especially in individuals who already have loss of bone and muscle mass before surgery. For this reason, the assessment of bone mass and body composition in the preoperative period of these individuals is fundamental. In order to identify the benefits of weight loss promoted by surgery and life expectancy, the elderly patients in preparation for operation at the Bariatric Surgery Unit of the Hospital das Clinicas University of São Paulo School of Medicine are submitted to a geriatric evaluation, which includes the analysis of their functional dependency profile, Important prognostic factor in this population. Objectives: The primary objective of the study will be to evaluate surgical morbidity and short-term (weight loss, comorbid control) outcomes of surgical treatment of obesity in patients over 65 years of age, comparing two techniques: Sleeve Gastrectomy (SG) and Gastric Bypass (GB). The secondary objective will be to evaluate the body composition of the individuals, before and after the surgery, comparing the two techniques. Patients and methods: This is a prospective study, in which 40 consecutive patients, aged 65 years and over, will be admitted to the Bariatric and Metabolic Surgery Unit of the Discipline of Digestive System Surgery of Hospital das Clinicas University of São Paulo School of Medicine with indication criteria for bariatric surgery. Patients will be randomized into two groups according to the surgical technique to be used: SG or GB. Data related to surgical morbidity, weight loss, control of comorbidities, nutritional deficiencies, changes in body composition and functionality will be evaluated and compared after a follow-up of at least 12 months.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • BMI over 40 Kg/m2 for at least 5 years with failure of obesity medical treatments
  • BMI over 35 Kg/m2 with at least 2 comorbidities and failure of medical treatments

Exclusion criteria

  • prior bariatric surgery
  • clinical or psychological conditions that contraindicate bariatric surgery

Treatment and study plan

Sleeve gastrectomy

Procedure

Laparoscopic Sleeve Gastrectomy. Technique: complete mobilization of the greater curvature and gastric fundus up to the angle of Hiss; stapling beginning at 3 to 4 cm away from the pylorus; bougie size 32 French; oversuture of the staple line; hiatoplasty in selected cases; routine drainage of the abdominal cavity

Other names: Vertical gastrectomy

Gastric bypass

Procedure

Laparoscopic Gastric Bypass. Technique: Pouch size 30 to 40 ml, biliopancreatic limb 70 to 100 cm, alimentary limb 100 to 120 cm, antecolic, routine closure of the mesenterial defects, routine drainage of the abdominal cavity

Other names: Roux-en_y Gastric Bypass

Primary outcomes

  1. Total Weight loss

    Time frame: 1 year

    Weight loss measured in percentage of weight loss (%WL)

  2. Surgical Complications

    Time frame: 30 days

    Bleeding, Leakage, Fistula, Bowel obstruction

  3. Mortality

    Time frame: 90 days

    mortality

  4. Improvement of Type II diabetes

    Time frame: baseline and 1 year

    Measure of glycated hemoglobin

  5. Improvement of hypertension

    Time frame: baseline and 1 year

    measure of blood pressure (mmHg)

  6. Improvement of LDL

    Time frame: baseline and 1 year

    measure of LDL

  7. Clinical complications

    Time frame: 30 days

    cardiac, pulmonary, other

  8. Excess weight loss

    Time frame: 1 year

    excess weight loss (%EWL); considering the normal weight the equivalent to the BMI 25 Kg/m2

  9. Improvement of hypertension by use of medication

    Time frame: baseline and 1 year

    evaluation of the number of drugs used to treat hypertension

  10. Improvement of HDL

    Time frame: baseline and 1 year

    measure of HDL

  11. Improvement of triglycerides

    Time frame: baseline and 1 year

    measure of triglycerides

Secondary outcomes

  1. Functionality

    Time frame: baseline and 1 year

    Functionality specific test (Activities of Day living)

  2. Body composition

    Time frame: baseline and 1 year

    Dexa (Dual-energy X-ray absorptiometry) body composition study

  3. Functionality

    Time frame: baseline and 1 year

    Functionality specific test (Instrumental activities of day living)

  4. Functionality

    Time frame: baseline and 1 year

    Time up and go test

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Registry information

Official study title

Sleeve Gastrectomy Versus Roux-en-Y Gastric Bypass for Treatment of Severe Obesity in Patients With 65 Years or Older: a Randomized Controlled Trial - The "BaSE" Trial - Bariatric Surgery in the Elderly.

Acronym: BaSE

Important dates

Study start
2017
Primary completion
2017
Study completion
2019
First posted
Nov 13, 2017
Registry last updated
Dec 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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