Morbid ObesityNCT01504685
Long-Term Results of a Randomized Trial Comparing Banded-versus-Standard Laparoscopic Roux-en-Y Gastric Bypass
A study testing Banded Laparoscopic Roux-en-Y gastric bypass and Unbanded Laparoscopic Roux- en-Y gastric bypass in people with Morbid Obesity, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Morbid Obesity
- What is being tested?
- Banded Laparoscopic Roux-en-Y gastric bypass and Unbanded Laparoscopic Roux- en-Y gastric bypass
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- May 2003to Aug 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- body mass index of 40-55 kg/m2
- agreed to participate in this study with informed consent signed
Who cannot join
None listed.
About this study
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.
Read the 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.
- Conditions
- Morbid Obesity
- Being tested
- Banded Laparoscopic Roux-en-Y gastric bypass, Unbanded Laparoscopic Roux- en-Y gastric bypass
- Keywords
- Morbid obesity, Obesity surgery, Gastric bypass, Banded gastric bypass
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Banded Laparoscopic Roux-en-Y gastric bypassProcedure or surgery
Also called BLRYGB, banded 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 bypassProcedure or surgery
Also called Gastric bypass, LRYGB
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.
| Study group | Role | What they receive |
|---|---|---|
| Unbanded laparoscopic gastric bypass | Active comparator | Laparoscopic Roux- en-Y gastric bypass without any band around de gastric reservoir Receives: Procedure: Unbanded Laparoscopic Roux- en-Y gastric bypass |
| Banded laparoscopic gastric bypass | Active comparator | Placement of a premeasured band or ring around the gastric reservoir, adjacent to the gastroenterostomy. Receives: Procedure: Banded Laparoscopic Roux-en-Y gastric bypass |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with postoperative morbidity
determine any morbidity related to the surgical procedure through the 5 years follow up
Measured: 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.
Measured: 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
Measured: 3,6,9 months and 1,2,5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2012 (estimated)
- Study startMay 2003
- Primary completionMar 2005
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miguel F Herrera, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Investigators
- Miguel F Herrera, MD., PhD, Principal investigator, Instituto Nacional de Ciencias Medicas y Nutrición "Salavador Zubirán"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01504685
- Sponsor's protocol ID
- banded/unbandedBypassINNSZ
- Status last verified
- Jan 2012
- First submitted
- 2 Jan 2012
- Last updated
- 26 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Results of a Randomized Trial Comparing Banded-versus-Standard Laparoscopic Roux-en-Y Gastric Bypass
- ClinicalTrials.gov ID
- NCT01504685
- Acronym / sponsor ID
- banded/unbandedBypassINNSZ
- Conditions
- Morbid Obesity
- Keywords
- Morbid obesity, Obesity surgery, Gastric bypass, Banded gastric bypass
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranUniversity, hospital or other
- Study start
- May 2003
- Primary completion
- Mar 2005 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 5 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Unbanded laparoscopic gastric bypass | Active comparator | Procedure: Unbanded Laparoscopic Roux- en-Y gastric bypassLaparoscopic Roux- en-Y gastric bypass without any band around de gastric reservoir |
| Banded laparoscopic gastric bypass | Active comparator | Procedure: Banded Laparoscopic Roux-en-Y gastric bypassPlacement of a premeasured band or ring around the gastric reservoir, adjacent to the gastroenterostomy. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- body mass index of 40-55 kg/m2
- agreed to participate in this study with informed consent signed
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Banded Laparoscopic Roux-en-Y gastric bypassAlso: BLRYGB, banded gastric bypassA 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. | Procedure or surgery | Banded laparoscopic gastric bypass |
| Unbanded Laparoscopic Roux- en-Y gastric bypassAlso: Gastric bypass, LRYGBA 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. | Procedure or surgery | Unbanded laparoscopic gastric bypass |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miguel F Herrera, MD., PhD principal investigator
Instituto Nacional de Ciencias Medicas y Nutrición "Salavador Zubirán"
Questions about this trial
What is this clinical trial studying?
A study testing Banded Laparoscopic Roux-en-Y gastric bypass and Unbanded Laparoscopic Roux- en-Y gastric bypass in people with Morbid Obesity, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with postoperative morbidity (time frame: up to 5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2012.