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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:
ClinicalTrials.gov Identifier:
NCT01504685
First Posted: January 5, 2012
Last Update Posted: January 26, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Miguel F Herrera, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
  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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Long-Term Results of a Randomized Trial Comparing Banded-versus-Standard Laparoscopic Roux-en-Y Gastric Bypass

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

Primary Outcome Measures:
  • Number of participants with postoperative morbidity [ Time Frame: up to 5 years ]
    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 ]
    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 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: January 2, 2012
First Posted: January 5, 2012
Last Update Posted: January 26, 2012
Last Verified: January 2012

Keywords provided by Miguel F Herrera, 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