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Long-Term Results of a Randomized Trial Comparing Banded-versus-Standard Laparoscopic Roux-en-Y Gastric Bypass

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Miguel F Herrera, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
ClinicalTrials.gov Identifier:
NCT01504685
First received: January 2, 2012
Last updated: January 25, 2012
Last verified: January 2012
History of Changes
  Purpose

The purpose of the study is comparatively analyze the advantages and disadvantages of banded versus unbanded laparoscopic Roux-en-Y gastric bypass (RYGB).

The outcome variables of the general study included morbidity, maximal weight loss, and late weight regain.


Condition Intervention
Morbid Obesity
 Procedure: Banded Laparoscopic Roux-en-Y gastric bypass
Procedure: Unbanded Laparoscopic Roux- en-Y gastric bypass

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Long-Term Results of a Randomized Trial Comparing Banded-versus-Standard Laparoscopic Roux-en-Y Gastric Bypass

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran:

Primary Outcome Measures:
  • Number of participants with postoperative morbidity [ Time Frame: up to 5 years ] [ Designated as safety issue: Yes ]
    determine any morbidity related to the surgical procedure through the 5 years follow up

  • Change from Baseline weight assessed at different time points to determine maximal weight loss, [ Time Frame: 3,6,9 months and 1,2,5 years ] [ Designated as safety issue: No ]
    determine changes in weight loss through 5 years follow up, measuring maximal weight loss.

  • Changes in weight assessed at different time points to determine weight regain [ Time Frame: 3,6,9 months and 1,2,5 years ] [ Designated as safety issue: No ]
    identify changes in weight regain during the postoperative 5 years follow up


Enrollment: 60
Study Start Date: May 2003
Study Completion Date: August 2010
Primary Completion Date: March 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Unbanded laparoscopic gastric bypass
Laparoscopic Roux- en-Y gastric bypass without any band around de gastric reservoir
 Procedure: Unbanded Laparoscopic Roux- en-Y gastric bypass

A hand-sewn gastrojejunostomy in 2 layers using 3-0 Polyglactin for the internal and 3-0 silk for the external layer.

To ensure a diameter of 1-1.5 cm,a 32F bougie was used to calibrate the gastro jejunum anastomosis. The length of alimentary and biliopancreatic limbs was approximately 150 cm and 50 cm, respectively.

Other Names:
  • Gastric bypass
  • LRYGB
Active Comparator: Banded laparoscopic gastric bypass
Placement of a premeasured band or ring around the gastric reservoir, adjacent to the gastroenterostomy.
 Procedure: Banded Laparoscopic Roux-en-Y gastric bypass

A 6.5-cm polypropylene Marlex mesh was placed immediately cephalad to the gastrojejunostomy. The gastrojejunostomy was hand-sewn in 2 layers using 3-0 Polyglactin for the internal and 3-0 silk for the external layer.

The length of alimentary and biliopancreatic limbs was approximately 150 cm and 50 cm, respectively.

Other Names:
  • BLRYGB
  • banded gastric bypass

Detailed Description:

Obesity is a public health problem that has grown exponentially worldwide. Bariatric surgery has been recognized as the most effective treatment for morbid obesity. However, the debate about the best surgical procedure is still considerable.

Among a wide range of operations that have been used for morbid obesity, Roux-en-Y gastric bypass (RYGB) has shown an appropriate risk/benefit balance and has achieved a high degree of acceptance in America.

The weight loss pattern in RYGB is characteristic and includes significant eight loss during the first 2 years after surgery, followed by some weight regain after the second or third postoperative year. To prevent this some authors suggest the placement of a premeasured band or ring around the gastric reservoir, adjacent to the gastroenterostomy. This procedure has been called banded RYGB.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • body mass index of 40-55 kg/m2
  • agreed to participate in this study with informed consent signed
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01504685

Sponsors and Collaborators
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Investigators
Principal Investigator: Miguel F Herrera, MD., PhD Instituto Nacional de Ciencias Medicas y Nutrición "Salavador Zubirán"
  More Information

No publications provided

Responsible Party: Miguel F Herrera, Miguel F. Herrera, M.D., Ph.D., Principal Investigator, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
ClinicalTrials.gov Identifier: NCT01504685     History of Changes
Other Study ID Numbers: banded/unbandedBypassINNSZ
Study First Received: January 2, 2012
Last Updated: January 25, 2012
Health Authority: Mexico: Ethics Committee

Keywords provided by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran:
Morbid obesity
Obesity surgery
Gastric bypass
Banded gastric bypass

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

ClinicalTrials.gov processed this record on May 22, 2013