Long-Term Results of a Randomized Trial Comparing Banded-versus-Standard Laparoscopic Roux-en-Y Gastric Bypass
1 other identifier
interventional
60
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2003
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2010
CompletedFirst Submitted
Initial submission to the registry
January 2, 2012
CompletedFirst Posted
Study publicly available on registry
January 5, 2012
CompletedJanuary 26, 2012
January 1, 2012
1.8 years
January 2, 2012
January 25, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Number of participants with postoperative morbidity
determine any morbidity related to the surgical procedure through the 5 years follow up
up to 5 years
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.
3,6,9 months and 1,2,5 years
Changes in weight assessed at different time points to determine weight regain
identify changes in weight regain during the postoperative 5 years follow up
3,6,9 months and 1,2,5 years
Study Arms (2)
Unbanded laparoscopic gastric bypass
ACTIVE COMPARATORLaparoscopic Roux- en-Y gastric bypass without any band around de gastric reservoir
Banded laparoscopic gastric bypass
ACTIVE COMPARATORPlacement of a premeasured band or ring around the gastric reservoir, adjacent to the gastroenterostomy.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- body mass index of 40-55 kg/m2
- agreed to participate in this study with informed consent signed
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Miguel F Herrera, MD., PhD
Instituto Nacional de Ciencias Medicas y Nutrición "Salavador Zubirán"
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Miguel F. Herrera, M.D., Ph.D., Principal Investigator
Study Record Dates
First Submitted
January 2, 2012
First Posted
January 5, 2012
Study Start
May 1, 2003
Primary Completion
March 1, 2005
Study Completion
August 1, 2010
Last Updated
January 26, 2012
Record last verified: 2012-01