Skip to content

Sleeve Versus Bypass in Older Patients: a Randomized Controlled Trial

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.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03339791
Acronym
BaSE
Enrollment
36
Registered
2017-11-13
Start date
2017-09-23
Completion date
2019-07-16
Last updated
2020-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Elderly, Obesity, Morbid, Surgery

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.

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.

Interventions

PROCEDURESleeve 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

PROCEDUREGastric 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

Sponsors

University of Sao Paulo General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Randomized controlled trial

Eligibility

Sex/Gender
ALL
Age
65 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Improvement of triglyceridesbaseline and 1 yearmeasure of triglycerides
Improvement of hypertension by use of medicationbaseline and 1 yearevaluation of the number of drugs used to treat hypertension
Improvement of HDLbaseline and 1 yearmeasure of HDL
Excess weight loss1 yearexcess weight loss (%EWL); considering the normal weight the equivalent to the BMI 25 Kg/m2
Total Weight loss1 yearWeight loss measured in percentage of weight loss (%WL)
Surgical Complications30 daysBleeding, Leakage, Fistula, Bowel obstruction
Mortality90 daysmortality
Improvement of Type II diabetesbaseline and 1 yearMeasure of glycated hemoglobin
Improvement of hypertensionbaseline and 1 yearmeasure of blood pressure (mmHg)
Improvement of LDLbaseline and 1 yearmeasure of LDL
Clinical complications30 dayscardiac, pulmonary, other

Secondary

MeasureTime frameDescription
Body compositionbaseline and 1 yearDexa (Dual-energy X-ray absorptiometry) body composition study
Functionalitybaseline and 1 yearFunctionality specific test (Activities of Day living)

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026