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Sleeve Versus Bypass in Older Patients: a Randomized Controlled Trial (BaSE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03339791
Recruitment Status : Completed
First Posted : November 13, 2017
Last Update Posted : August 20, 2019
Sponsor:
Information provided by (Responsible Party):
Denis Pajecki, University of Sao Paulo General Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Obesity, Morbid Surgery Elderly Procedure: Sleeve Gastrectomy Procedure: Gastric Bypass Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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.
Actual Study Start Date : September 23, 2017
Actual Primary Completion Date : November 7, 2017
Actual Study Completion Date : July 16, 2019

Arm Intervention/treatment
Active Comparator: Sleeve
Morbid obese patients, 65 years old or more, submitted to Sleeve Gastrectomy
Procedure: Sleeve Gastrectomy
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 Name: Vertical gastrectomy

Active Comparator: Bypass
Morbid obese patients, 65 years old or more, submitted to Gastric Bypass
Procedure: Gastric Bypass
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 Name: Roux-en_y Gastric Bypass




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 80 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03339791


Locations
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Brazil
Hospital das Clinicas da Faculdade de Medicina da USP
São Paulo, Brazil, 05403-000
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
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Principal Investigator: Denis Pajecki Hospital das Clinicas - Faculdade de Medicina da USP
Publications:
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Responsible Party: Denis Pajecki, Principal Investigator, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT03339791    
Other Study ID Numbers: 68401117.4.0000.0068
First Posted: November 13, 2017    Key Record Dates
Last Update Posted: August 20, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The plan is to publish the complete data after the end of the study

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity
Obesity, Morbid
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms