Long-Term Results of a Randomized Trial Comparing Banded-versus-Standard Laparoscopic Roux-en-Y Gastric Bypass
NCT ID: NCT01504685
Last Updated: 2012-01-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
60 participants
INTERVENTIONAL
2003-05-31
2010-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The outcome variables of the general study included morbidity, maximal weight loss, and late weight regain.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Comparison Between Short vs. Long Biliopancreatic Limb Gastric Bypass
NCT04609449
Banded Versus Non-banded Roux-en-y Gastric Bypass
NCT02545647
Comparison of Mini Gastric Bypass and Roux-en-Y Gastric Bypass
NCT02882685
Laparoscopic Gastric Bypass Versus Laparoscopic Banded Gastric Bypass Randomized Prospective Clinical Trial
NCT02939664
Long or Very Long-Limb Gastric Bypass in Superobese
NCT00868543
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Unbanded laparoscopic gastric bypass
Laparoscopic Roux- en-Y gastric bypass without any band around de gastric reservoir
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.
Banded laparoscopic gastric bypass
Placement of a premeasured band or ring around the gastric reservoir, adjacent to the gastroenterostomy.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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 Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* agreed to participate in this study with informed consent signed
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Miguel F Herrera
Miguel F. Herrera, M.D., Ph.D., Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Miguel F Herrera, MD., PhD
Role: PRINCIPAL_INVESTIGATOR
Instituto Nacional de Ciencias Medicas y Nutrición "Salavador Zubirán"
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
banded/unbandedBypassINNSZ
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.