Sleeve Versus Bypass in Older Patients: a Randomized Controlled Trial

NCT03339791 | Completed

• 1 other identifier: 68401117.4.0000.0068
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity, Morbid; Surgery; Elderly

Outcome Measures

Primary Outcomes (11)

• 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 Outcomes (4)

• Functionality

  baseline and 1 year

• Body composition

  baseline and 1 year

• Functionality

  baseline and 1 year

• Functionality

  baseline and 1 year

Study Arms (2)

Sleeve

ACTIVE COMPARATOR

Morbid obese patients, 65 years old or more, submitted to Sleeve Gastrectomy

Procedure: Sleeve Gastrectomy

Bypass

ACTIVE COMPARATOR

Morbid obese patients, 65 years old or more, submitted to Gastric Bypass

Procedure: Gastric Bypass

Interventions

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

Also known as: Vertical gastrectomy

Sleeve

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

Also known as: Roux-en_y Gastric Bypass

Bypass

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Hospital das Clinicas da Faculdade de Medicina da USP

São Paulo, 05403-000, Brazil

Location

Related Publications (4)

• 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.

  PMID: 26193177 BACKGROUND

• 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.

  PMID: 26001882 BACKGROUND

• 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.

  PMID: 24760060 BACKGROUND

• 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.

  PMID: 22118843 BACKGROUND

MeSH Terms

Conditions

Obesity, Morbid

Interventions

Gastric Bypass

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bariatric Surgery; Bariatrics; Obesity Management; Therapeutics; Gastroenterostomy; Anastomosis, Surgical; Surgical Procedures, Operative; Digestive System Surgical Procedures

Study Officials

• Denis Pajecki

  Hospital das Clinicas - Faculdade de Medicina da USP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: October 30, 2017
• First Posted: November 13, 2017
• Study Start: September 23, 2017
• Primary Completion: November 7, 2017
• Study Completion: July 16, 2019
• Last Updated: December 2, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)