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Obesity, MorbidBaSENCT03339791

Sleeve Versus Bypass in Older Patients: a Randomized Controlled Trial

A study testing Sleeve Gastrectomy and Gastric Bypass in people with Obesity, Morbid and Surgery, run by University of Sao Paulo General Hospital at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 to 80 years
Conditions the study is for
Obesity, Morbid, Surgery, Elderly
What is being tested?
Sleeve Gastrectomy and Gastric Bypass
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteBrazil
Study dates
23 Sep 2017to 16 Jul 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 to 80 years
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Hospital das Clinicas da Faculdade de Medicina da USP

    São Paulo, 05403-000

Other trials in Brazil

About this study

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.

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.

Read the 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.

Being tested
Sleeve Gastrectomy, Gastric Bypass
Medical subject headings
Obesity, Morbid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sleeve GastrectomyProcedure or surgery

    Also called Vertical 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

  • Gastric BypassProcedure or surgery

    Also called Roux-en_y 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

Study groups in NCT03339791
Study groupRoleWhat they receive
SleeveActive comparatorMorbid obese patients, 65 years old or more, submitted to Sleeve Gastrectomy
Receives: Procedure: Sleeve Gastrectomy
BypassActive comparatorMorbid obese patients, 65 years old or more, submitted to Gastric Bypass
Receives: Procedure: Gastric Bypass

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total Weight loss

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

    Measured: 1 year

  2. Surgical Complications

    Bleeding, Leakage, Fistula, Bowel obstruction

    Measured: 30 days

  3. Mortality

    mortality

    Measured: 90 days

  4. Improvement of Type II diabetes

    Measure of glycated hemoglobin

    Measured: baseline and 1 year

  5. Improvement of hypertension

    measure of blood pressure (mmHg)

    Measured: baseline and 1 year

  6. Improvement of LDL

    measure of LDL

    Measured: baseline and 1 year

  7. Clinical complications

    cardiac, pulmonary, other

    Measured: 30 days

  8. Excess weight loss

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

    Measured: 1 year

  9. Improvement of hypertension by use of medication

    evaluation of the number of drugs used to treat hypertension

    Measured: baseline and 1 year

  10. Improvement of HDL

    measure of HDL

    Measured: baseline and 1 year

  11. Improvement of triglycerides

    measure of triglycerides

    Measured: baseline and 1 year

Secondary outcomes (4)

  1. Functionality

    Functionality specific test (Activities of Day living)

    Measured: baseline and 1 year

  2. Body composition

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

    Measured: baseline and 1 year

  3. Functionality

    Functionality specific test (Instrumental activities of day living)

    Measured: baseline and 1 year

  4. Functionality

    Time up and go test

    Measured: baseline and 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Nov 2017
  2. Study start23 Sep 2017
  3. Primary completion7 Nov 2017
  4. Study completion16 Jul 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized controlled trial
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03339791
Sponsor's protocol ID
68401117.4.0000.0068
Acronym
BaSE
Status last verified
Dec 2020
First submitted
30 Oct 2017
Last updated
2 Dec 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The plan is to publish the complete data after the end of the study

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.

    PubMed 26193177

  • 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.

    PubMed 26001882

  • 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.

    PubMed 24760060

  • 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.

    PubMed 22118843

Questions about this trial

What is this clinical trial studying?

A study testing Sleeve Gastrectomy and Gastric Bypass in people with Obesity, Morbid and Surgery, run by University of Sao Paulo General Hospital at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total Weight loss (time frame: 1 year). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03339791, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2020.

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