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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

January 2, 2012
January 25, 2012
May 2003
March 2005   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01504685 on ClinicalTrials.gov Archive Site
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Long-Term Results of a Randomized Trial Comparing Banded-versus-Standard Laparoscopic Roux-en-Y Gastric Bypass
Long-Term Results of a Randomized Trial Comparing Banded-versus-Standard Laparoscopic Roux-en-Y Gastric Bypass

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.

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Morbid Obesity
  • 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
  • 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: Unbanded laparoscopic gastric bypass
    Laparoscopic Roux- en-Y gastric bypass without any band around de gastric reservoir
    Intervention: Procedure: Unbanded Laparoscopic Roux- en-Y gastric bypass
  • Active Comparator: Banded laparoscopic gastric bypass
    Placement of a premeasured band or ring around the gastric reservoir, adjacent to the gastroenterostomy.
    Intervention: Procedure: Banded Laparoscopic Roux-en-Y gastric bypass
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
August 2010
March 2005   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • body mass index of 40-55 kg/m2
  • agreed to participate in this study with informed consent signed
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01504685
banded/unbandedBypassINNSZ
No
Miguel F Herrera, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Not Provided
Principal Investigator: Miguel F Herrera, MD., PhD Instituto Nacional de Ciencias Medicas y Nutrición "Salavador Zubirán"
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP