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

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.

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.

Study Overview

• Status: Completed
• Conditions: Surgery; Obesity, Morbid; Elderly
• Intervention / Treatment: Procedure: Sleeve Gastrectomy; Procedure: Gastric Bypass

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.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 05403-000
    • Hospital Das Clinicas Da Faculdade De Medicina Da USP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 80 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Roux-en_y Gastric Bypass

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Weight loss	Weight loss measured in percentage of weight loss (%WL)	1 year
Surgical Complications	Bleeding, Leakage, Fistula, Bowel obstruction	30 days
Mortality	mortality	90 days
Improvement of Type II diabetes	Measure of glycated hemoglobin	baseline and 1 year
Improvement of hypertension	measure of blood pressure (mmHg)	baseline and 1 year
Improvement of LDL	measure of LDL	baseline and 1 year
Clinical complications	cardiac, pulmonary, other	30 days
Excess weight loss	excess weight loss (%EWL); considering the normal weight the equivalent to the BMI 25 Kg/m2	1 year
Improvement of hypertension by use of medication	evaluation of the number of drugs used to treat hypertension	baseline and 1 year
Improvement of HDL	measure of HDL	baseline and 1 year
Improvement of triglycerides	measure of triglycerides	baseline and 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functionality	Functionality specific test (Activities of Day living)	baseline and 1 year
Body composition	Dexa (Dual-energy X-ray absorptiometry) body composition study	baseline and 1 year
Functionality	Functionality specific test (Instrumental activities of day living)	baseline and 1 year
Functionality	Time up and go test	baseline and 1 year

Collaborators and Investigators

• Sponsor: University of Sao Paulo General Hospital
• Investigators: Principal Investigator: Denis Pajecki, Hospital das Clínicas - Faculdade de Medicina da USP

Publications and helpful links

General Publications

• Maghrabi AH, Wolski K, Abood B, Licata A, Pothier C, Bhatt DL, Nissen S, Brethauer SA, Kirwan JP, Schauer PR, Kashyap SR. Two-year outcomes on bone density and fracture incidence in patients with T2DM randomized to bariatric surgery versus intensive medical therapy. Obesity (Silver Spring). 2015 Dec;23(12):2344-8. doi: 10.1002/oby.21150. Epub 2015 Jul 20.
• Abbas M, Cumella L, Zhang Y, Choi J, Vemulapalli P, Melvin WS, Camacho D. Outcomes of Laparoscopic Sleeve Gastrectomy and Roux-en-Y Gastric Bypass in Patients Older than 60. Obes Surg. 2015 Dec;25(12):2251-6. doi: 10.1007/s11695-015-1712-9.
• Pajecki D, Santo MA, Kanagi AL, Riccioppo D, de Cleva R, Cecconello I. Functional assessment of older obese patients candidates for bariatric surgery. Arq Gastroenterol. 2014 Jan-Mar;51(1):25-8. doi: 10.1590/s0004-28032014000100006.
• Strain GW, Gagner M, Pomp A, Dakin G, Inabnet WB, Saif T. Comparison of fat-free mass in super obesity (BMI >/= 50 kg/m2) and morbid obesity (BMI <50 kg/m2) in response to different weight loss surgeries. Surg Obes Relat Dis. 2012 May-Jun;8(3):255-9. doi: 10.1016/j.soard.2011.09.028. Epub 2011 Oct 20.

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2017
• Primary Completion (Actual): November 7, 2017
• Study Completion (Actual): July 16, 2019

Study Registration Dates

• First Submitted: October 30, 2017
• First Submitted That Met QC Criteria: November 7, 2017
• First Posted (Actual): November 13, 2017

Study Record Updates

• Last Update Posted (Actual): December 2, 2020
• Last Update Submitted That Met QC Criteria: December 1, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Obesity, Morbid
• Other Study ID Numbers: 68401117.4.0000.0068

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: The plan is to publish the complete data after the end of the study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No