Morbid ObesityPhase 3STAVHASNCT02077517
Stapled vs Hand Sewn Anastomosis in Roux en Y Gastric Bypass for Morbid Obesity: Randomized Clinical Trial
A Phase 3 study testing Roux en Y Gastric Bypass in people with Morbid Obesity, run by Hospital Universitario Virgen de la Arrixaca at 1 site in Spain.
Trial summary
The purpose of this study is to compare postoperative complications between hand sewn and stapled anastomosis after performing Roux en Y-Gastric Bypass as a treatment for morbid obesity. 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?
- 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
- 400 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2007to Jan 2014
- Phase
- Phase 3
- 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
- patients over 18 years
- absence of previous bariatric surgery
Who cannot join
- less than 18 years old
- coagulation disorders or liver cirrhosis
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Clinico Universitario Virgen de la Arrixaca
El Palmar, Murcia
Israel Abellan, Ph, 615217706
Israel Abellan, Ph
About this study
The purpose of this study is to compare postoperative complications between hand sewn and stapled anastomosis after performing Roux en Y-Gastric Bypass as a treatment for morbid obesity.
- Conditions
- Morbid Obesity
- Being tested
- Roux en Y Gastric Bypass
- Keywords
- Roux en Y Gastric Bypass, Postoperative complications, Hand sewn anastomosis, Stapled anastomosis
- Medical subject headings
- Obesity, Morbid, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Roux en Y Gastric BypassProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| hand sewn anastomosis | Active comparator | Patients with hand sewn anastomosis during Roux en Y Gastric bypass performing Receives: Procedure: Roux en Y Gastric Bypass |
| stapled anastomosis | Active comparator | Patients with stapled anastomosis during Roux en Y Gastric Bypass performing Receives: Procedure: Roux en Y Gastric Bypass |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative complications
To compare postoperative complications after bariatric surgery between stapled anastomosis and hand sewn anastomosis
Measured: within the first month after surgery
Secondary outcomes (2)
hospital stay
Measured: within the first month after surgery
% of excess weight lost
Measured: five years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2014 (estimated)
- Study startJan 2007
- Primary completionJan 2014
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Virgen de la Arrixaca
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Israel Abellan Morcillo, Hospital Universitario Virgen de la Arrixaca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02077517
- Sponsor's protocol ID
- OBES-001
- Acronym
- STAVHAS
- Status last verified
- Mar 2014
- First submitted
- 24 Feb 2014
- Last updated
- 4 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stapled vs Hand Sewn Anastomosis in Roux en Y Gastric Bypass for Morbid Obesity: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02077517
- Acronym / sponsor ID
- STAVHAS / OBES-001
- Conditions
- Morbid Obesity
- Keywords
- Roux en Y Gastric Bypass, Postoperative complications, Hand sewn anastomosis, Stapled anastomosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Hospital Universitario Virgen de la ArrixacaUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Jan 2014 (actual)
- First posted
- 4 Mar 2014 (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 this study is to compare postoperative complications between hand sewn and stapled anastomosis after performing Roux en Y-Gastric Bypass as a treatment for morbid obesity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hand sewn anastomosis | Active comparator | Procedure: Roux en Y Gastric BypassPatients with hand sewn anastomosis during Roux en Y Gastric bypass performing |
| stapled anastomosis | Active comparator | Procedure: Roux en Y Gastric BypassPatients with stapled anastomosis during Roux en Y Gastric Bypass performing |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients over 18 years
- absence of previous bariatric surgery
Key exclusion criteria (2 listed)
- less than 18 years old
- coagulation disorders or liver cirrhosis
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 |
|---|---|---|
| Roux en Y Gastric Bypass | Procedure or surgery | hand sewn anastomosis, stapled anastomosis |
Primary outcome
postoperative complications
Time frame: within the first month after surgery
To compare postoperative complications after bariatric surgery between stapled anastomosis and hand sewn anastomosis
2 secondary outcomes
hospital stay
Time frame: within the first month after surgery
% of excess weight lost
Time frame: five years after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2014.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Roux en Y Gastric Bypass in people with Morbid Obesity, run by Hospital Universitario Virgen de la Arrixaca at 1 site in Spain.
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 2 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: status not confirmed, as of the sponsor's last update on 4 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative complications (time frame: within the first month after surgery). 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 4 Mar 2014.