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

Primary Purpose

Morbid Obesity

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Banded Laparoscopic Roux-en-Y gastric bypass
Unbanded Laparoscopic Roux- en-Y gastric bypass
Sponsored by
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Morbid Obesity focused on measuring Morbid obesity, Obesity surgery, Gastric bypass, Banded gastric bypass

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • body mass index of 40-55 kg/m2
  • agreed to participate in this study with informed consent signed

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Unbanded laparoscopic gastric bypass

    Banded laparoscopic gastric bypass

    Arm Description

    Laparoscopic Roux- en-Y gastric bypass without any band around de gastric reservoir

    Placement of a premeasured band or ring around the gastric reservoir, adjacent to the gastroenterostomy.

    Outcomes

    Primary Outcome Measures

    Number of participants with postoperative morbidity
    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,
    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
    identify changes in weight regain during the postoperative 5 years follow up

    Secondary Outcome Measures

    Full Information

    First Posted
    January 2, 2012
    Last Updated
    January 25, 2012
    Sponsor
    Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01504685
    Brief Title
    Long-Term Results of a Randomized Trial Comparing Banded-versus-Standard Laparoscopic Roux-en-Y Gastric Bypass
    Official Title
    Long-Term Results of a Randomized Trial Comparing Banded-versus-Standard Laparoscopic Roux-en-Y Gastric Bypass
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2003 (undefined)
    Primary Completion Date
    March 2005 (Actual)
    Study Completion Date
    August 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Morbid Obesity
    Keywords
    Morbid obesity, Obesity surgery, Gastric bypass, Banded gastric bypass

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Unbanded laparoscopic gastric bypass
    Arm Type
    Active Comparator
    Arm Description
    Laparoscopic Roux- en-Y gastric bypass without any band around de gastric reservoir
    Arm Title
    Banded laparoscopic gastric bypass
    Arm Type
    Active Comparator
    Arm Description
    Placement of a premeasured band or ring around the gastric reservoir, adjacent to the gastroenterostomy.
    Intervention Type
    Procedure
    Intervention Name(s)
    Banded Laparoscopic Roux-en-Y gastric bypass
    Other Intervention Name(s)
    BLRYGB, banded gastric bypass
    Intervention Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    Unbanded Laparoscopic Roux- en-Y gastric bypass
    Other Intervention Name(s)
    Gastric bypass, LRYGB
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Number of participants with postoperative morbidity
    Description
    determine any morbidity related to the surgical procedure through the 5 years follow up
    Time Frame
    up to 5 years
    Title
    Change from Baseline weight assessed at different time points to determine maximal weight loss,
    Description
    determine changes in weight loss through 5 years follow up, measuring maximal weight loss.
    Time Frame
    3,6,9 months and 1,2,5 years
    Title
    Changes in weight assessed at different time points to determine weight regain
    Description
    identify changes in weight regain during the postoperative 5 years follow up
    Time Frame
    3,6,9 months and 1,2,5 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: body mass index of 40-55 kg/m2 agreed to participate in this study with informed consent signed
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Miguel F Herrera, MD., PhD
    Organizational Affiliation
    Instituto Nacional de Ciencias Medicas y Nutrición "Salavador Zubirán"
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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