Banded Sleeve Gastrectomy Versus Banded Ring Gastric Bypass in Morbidly Obese Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by Federal University of Espirito Santo.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Federal University of São Paulo
Information provided by:
Federal University of Espirito Santo
ClinicalTrials.gov Identifier:
NCT00873405
First received: March 31, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
  Purpose

Obesity is a multifactorial disease that affects millions of people worldwide. It is the main independent risk factor for developing type 2 diabetes mellitus (T2DM). Most patients with T2DM and glucose intolerance (GI) are overweight, a condition known as diabesity. In patients with the most severe form of obesity, i.e., morbid obesity, the likelihood of developing diseases associated with obesity is increased.

The investigators currently know that bariatric surgery provides sustained weight loss and well-documented remission of T2DM. Patients who undergo bariatric surgery show long-term reduced mortality from coronary artery disease, cancer and diabetes; 136 lives are saved per 10,000 surgical procedures performed. Bariatric surgery is a relatively safe procedure that is becoming increasingly well-accepted; in 2007, approximately 170,000 bariatric procedures were performed in the USA. Currently, bariatric surgery is the most effective choice of treatment of morbidly obese patients with diabetes.

The surgical procedures that are currently performed to treat morbid obesity are divided into two main groups: gastric restrictive procedures and combination procedures; the latter combine gastric restriction and malabsorption. The roux-en-Y gastric bypass (RYGB) is the combination procedure most frequently performed, whereas sleeve gastrectomy (SG) is an emerging restrictive procedure. SG can be performed as the first of a two-stage operation in patients at high risk of death, or as a definitive surgical procedure. It has shown good results with regard to weight loss and glycemic control in various studies. The potential advantages of SG include lower probability of vitamin and mineral deficiencies because this procedure has no malabsorptive component; access to the entire intestinal tract; no need for a subcutaneous access port or adjustments; absence of dumping syndrome and lower probability of intestinal obstruction. In addition, SG can be performed in patients who have inflammatory bowel disease or who have undergone bowel surgery, and it can be easily converted into RYGB. Both SG and RYGB can be performed with or without the placement of a Silastic® ring.

The metabolic control achieved with bariatric procedures has been demonstrated and reproduced in various medical centers worldwide. Metabolic control can be achieved with gastric restrictive procedures such as vertical banded gastroplasty, adjustable gastric banding and, more recently, SG. However, it has been shown that glucose homeostasis is affected by various intestinal mechanisms observed exclusively in procedures that include a malabsorptive element, such as RYGB.

A systematic review of 22,094 cases of morbidly obese patients submitted to bariatric surgery has shown that resolution of T2DM was achieved in 76.8% of the cases, improvement being achieved in 86% of cases. Among the criteria used to diagnose metabolic syndrome, fasting glucose levels are the first to return to normal in patients submitted to Silastic® ring gastric bypass (SRGB), a modification of the traditional RYGB which consists in adding a Silastic® ring to the gastric bypass operation. Normoglycemia after bariatric procedures, as well as diabesity itself, is multifactorial. Normoglycemia is observed as a result of dietary control, decreased plasma levels of ghrelin, weight loss and reduction of body fat, as well as of the release of gastrointestinal hormones that interfere with the function of pancreatic β cells (incretins).

The main purpose of this study was to compare the weight loss of morbidly obese patients submitted to either a Silastic® ring sleeve gastrectomy (SRSG) or an SRGB, as well as to compare the effects of both procedures on glucose homeostasis in morbidly obese patients.


Condition Intervention
Obesity
Procedure: Silastic® ring sleeve gastrectomy
Procedure: Silastic® ring gastric bypass

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Banded Sleeve Gastrectomy Versus Banded Ring Gastric Bypass in Morbidly Obese Patients: a Prospective Controlled Trial.

Resource links provided by NLM:


Further study details as provided by Federal University of Espirito Santo:

Primary Outcome Measures:
  • Weight loss, BMI reduction and waist circumference reduction [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Glucose homeostasis, metabolic control. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 65
Study Start Date: June 2006
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: SRSG
Silastic® ring sleeve gastrectomy (SRSG).
Procedure: Silastic® ring sleeve gastrectomy
SRSG group: ligation of the vessels of the greater curvature of the body and fundus of stomach; resection of the fundus and part of the body of stomach using a linear stapler (80 mm, Tyco®) and a 32-Fr tube to calibrate the remaining stomach; placement of a 6.2 cm Silastic® ring around the stomach, 5.0 cm below the esophagogastric junction.
Other Name: Sleeve gastrectomy
SRGB
Silastic® ring gastric bypass.
Procedure: Silastic® ring sleeve gastrectomy
SRSG group: ligation of the vessels of the greater curvature of the body and fundus of stomach; resection of the fundus and part of the body of stomach using a linear stapler (80 mm, Tyco®) and a 32-Fr tube to calibrate the remaining stomach; placement of a 6.2 cm Silastic® ring around the stomach, 5.0 cm below the esophagogastric junction.
Other Name: Sleeve gastrectomy
Procedure: Silastic® ring gastric bypass
SRGB group: creation of a small, proximal gastric pouch using a linear stapler (80 mm, Tyco®) and a 32-Fr tube to calibrate the gastric pouch; creation of an intestinal loop of 150 cm and a biliopancreatic loop of 40 cm; placement of a 6.2 cm Silastic® ring around the stomach, 5.0 cm below the esophagogastric junction.
Other Name: gastric bypass

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • female patients aged 20-60 years
  • BMI 40-45 (inclusive)
  • agreed on giving written informed consent

Exclusion Criteria:

  • secondary obesity
  • alcohol or drug use
  • severe psychiatric disorder
  • binge-eating of sweets
  • previous stomach or bowel surgery
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00873405

Locations
Brazil
Cassiano Antonio Moraes University Hospital, Federal University of Espírito Santo
Vitória, Espírito Santo, Brazil, 29040-091
Sponsors and Collaborators
Federal University of Espirito Santo
Federal University of São Paulo
Investigators
Principal Investigator: Gustavo PS Miguel, Surgery Assistant Professor Federal University of Espírito Santo
  More Information

Publications:

Responsible Party: Gustavo Peixoto Soares Miguel, Federal University of Espirito Santo
ClinicalTrials.gov Identifier: NCT00873405     History of Changes
Other Study ID Numbers: 049/06
Study First Received: March 31, 2009
Last Updated: March 31, 2009
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Federal University of Espirito Santo:
Type 2 diabetes mellitus
Metabolic control
Bariatric Surgery
Weight Loss
Sleeve gastrectomy
BMI reduction
Waist circumference reduction
Percentage of excess BMI loss
Glucose homeostasis

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 11, 2014