Morbid ObesityRINGNCT01212835
Effect of RING on Gastroesophageal Reflux (GERD) After RYGBP
A study testing RYGBP-RING in people with Morbid Obesity and Gastroesophageal Reflux Disease, run by Clinica Gastrobese at 3 sites in Brazil.
Trial summary
Silastic rings have been used around the gastric pouch in order to promote better weight loss after Roux-and-Y gastric bypass surgery ( RYGBP). However the investigators have shown that some patients developed gastroesophageal reflux disease after RYGBP in a previous study. Read more about this study
- Who is it for?
- Ages 18 to 58 years
- Conditions the study is for
- Morbid Obesity, Gastroesophageal Reflux Disease, Vomiting
- What is being tested?
- RYGBP-RING
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 114 participants
- Where
- 3 sitesBrazil
- Study dates
- Oct 2010to Jan 2014
- 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 58 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Indications for bariatric surgery (BMI over 40Kg/m2 or over 35Kg/m2 associated to a life-treating morbid conditions.
- Acceptance to be submitted to a 24h pH-monitoring and esophageal manometry
- No contra-indication for gastric bypass
- Absence of previous gastric surgery
- Option for open gastric bypass
Who cannot join
- Inferior and superior total teeth prosthesis
- Poor surgical conditions
Trial locations and contacts
3 sites in 1 country.
Brazil3 sites
Clínica Gastrobese
Passo Fundo, Rio Grande do Sul, 99010112
Gastrobese Clinic
Passo Fundo, Rio Grande do Sul, 99020000
Hospital Sao Vicente de Paulo
Passo Fundo, Rio Grande do Sul, 99020000
About this study
Official title: The Use of a Silastic Ring in Open Gastric Bypass for Morbid Obesity and Its Association With Gastroesophageal Reflux Disease
Silastic rings have been used around the gastric pouch in order to promote better weight loss after Roux-and-Y gastric bypass surgery ( RYGBP). However the investigators have shown that some patients developed gastroesophageal reflux disease after RYGBP in a previous study. The investigators hypothesized that the use of a silastic ring may play a role in promoting GERD after this operation.
Read the detailed description
This is a randomized controlled double blind trial designed to identify if the use of the ring induces food intolerance and vomiting which may lead a esophageal mucosal erosions and/or GERD symptoms.
- Conditions
- Morbid Obesity, Gastroesophageal Reflux Disease, Vomiting
- Being tested
- Sham Comparator: no ring, RYGBP-RING
- Keywords
- Obesity, gastroesophageal reflux disease, Morbid obesity, esophagitis, GERD, silastic ring, Gastric bypass
- Medical subject headings
- Obesity, Morbid, Gastroesophageal Reflux, Vomiting, Obesity, Esophagitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sham Comparator: no ringProcedure or surgery
Open roux-en-Y gastric bypass not banded
RYGBP-RINGProcedure or surgery
Vertical Roux-en-Y banded gastric bypass
| Study group | Role | What they receive |
|---|---|---|
| no ring | Sham comparator | Patients at this group will have RING REMOVED AT THE END OF SURGERY. Receives: Procedure: Sham Comparator: no ring |
| RYGBP-Ring | Active comparator | Open Roux-en-Y gastric bypass with a silastic ring which is performed with linear cut stapler 100 mm and a biliopancreatic limb of 60 cm long and a alimentary limb of 100 cm long. All patients will have a 6.5 cm silastic ring located at the middle of the pouch above of the gastroenteroanastomosis. Receives: Procedure: RYGBP-RING |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurence of gastroesophageal reflux disease
Patients are intra-operatively selected to receive or not a silastic ring following a open gastric bypass. These patients will be evaluated for GERD with upper endoscopy, 24h ph-monitoring, validated questionnaires which will be performed at 6 month, 1 and 2 years.
Measured: march 2010 to march 2014
Secondary outcomes (2)
The role of the ring in open GBP in terms of weight loss
It will be possible to evaluate the weight loss among the groups: 1) with ring and, 2) without a ring
Measured: march 2010 to march 2014
The impact of the ring on food tolerance
To identify food intolerance among the groups: 1) with the ring, and 2) without the ring.
Measured: March 2010 to March 2014
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionMar 2012
- Study completionJan 2014
Why it stopped: lack of follow up
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinica Gastrobese
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlos AS Madalosso, Clinica Gastrobese
- Investigators
- Daniel Navarini, M.D., Study chair, Clinica GastrobeseCarlos AS Madalosso, M.D., Principal investigator, Clinica GastrobeseIran Moraes Jr, M.D., Study chair, Clinica GastrobeseFabio R Barao, Admn, Study director, Protocol control
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01212835
- Sponsor's protocol ID
- GASTROBESE 005
- Acronym
- RING
- Status last verified
- Dec 2015
- First submitted
- 29 Sep 2010
- Last updated
- 23 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Madalosso CA, Gurski RR, Callegari-Jacques SM, Navarini D, Thiesen V, Fornari F. The impact of gastric bypass on gastroesophageal reflux disease in patients with morbid obesity: a prospective study based on the Montreal Consensus. Ann Surg. 2010 Feb;251(2):244-8. doi: 10.1097/SLA.0b013e3181bdff20.
PubMed 20010088
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of a Silastic Ring in Open Gastric Bypass for Morbid Obesity and Its Association With Gastroesophageal Reflux Disease
- ClinicalTrials.gov ID
- NCT01212835
- Acronym / sponsor ID
- RING / GASTROBESE 005
- Conditions
- Morbid Obesity, Gastroesophageal Reflux Disease, Vomiting
- Keywords
- Obesity, gastroesophageal reflux disease, Morbid obesity, esophagitis, GERD, silastic ring, Gastric bypass
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of follow up
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Clinica GastrobeseUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 1 Oct 2010 (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.
Silastic rings have been used around the gastric pouch in order to promote better weight loss after Roux-and-Y gastric bypass surgery ( RYGBP). However the investigators have shown that some patients developed gastroesophageal reflux disease after RYGBP in a previous study. The investigators hypothesized that the use of a silastic ring may play a role in promoting GERD after this operation.
Detailed description
This is a randomized controlled double blind trial designed to identify if the use of the ring induces food intolerance and vomiting which may lead a esophageal mucosal erosions and/or GERD symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| no ring | Sham comparator | Procedure: Sham Comparator: no ringPatients at this group will have RING REMOVED AT THE END OF SURGERY. |
| RYGBP-Ring | Active comparator | Procedure: RYGBP-RINGOpen Roux-en-Y gastric bypass with a silastic ring which is performed with linear cut stapler 100 mm and a biliopancreatic limb of 60 cm long and a alimentary limb of 100 cm long. All patients will have a 6.5 cm silastic ring located at the middle of the pouch above of the gastroenteroanastomosis. |
Who may qualify
- Ages
- 18 to 58 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Indications for bariatric surgery (BMI over 40Kg/m2 or over 35Kg/m2 associated to a life-treating morbid conditions.
- Acceptance to be submitted to a 24h pH-monitoring and esophageal manometry
- No contra-indication for gastric bypass
- Absence of previous gastric surgery
- Option for open gastric bypass
Key exclusion criteria (2 listed)
- Inferior and superior total teeth prosthesis
- Poor surgical conditions
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 |
|---|---|---|
| Sham Comparator: no ringOpen roux-en-Y gastric bypass not banded | Procedure or surgery | no ring |
| RYGBP-RINGVertical Roux-en-Y banded gastric bypass | Procedure or surgery | RYGBP-Ring |
Primary outcome
Occurence of gastroesophageal reflux disease
Time frame: march 2010 to march 2014
Patients are intra-operatively selected to receive or not a silastic ring following a open gastric bypass. These patients will be evaluated for GERD with upper endoscopy, 24h ph-monitoring, validated questionnaires which will be performed at 6 month, 1 and 2 years.
2 secondary outcomes
The role of the ring in open GBP in terms of weight loss
Time frame: march 2010 to march 2014
The impact of the ring on food tolerance
Time frame: March 2010 to March 2014
Results and safety
The study was stopped early (reason given: lack of follow up). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2015.
- Results publication: PubMed 20010088Madalosso CA, Gurski RR, Callegari-Jacques SM, Navarini D, Thiesen V, Fornari F. The impact of gastric bypass on gastroesophageal reflux disease in patients with morbid obesity: a prospective study based on the Montreal Consensus. Ann Surg. 2010 Feb;251(2):244-8. doi: 10.1097/SLA.0b013e3181bdff20.
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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.
Daniel Navarini, M.D. study chair
Clinica Gastrobese
Carlos AS Madalosso, M.D. principal investigator
Clinica Gastrobese
Iran Moraes Jr, M.D. study chair
Clinica Gastrobese
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RYGBP-RING in people with Morbid Obesity and Gastroesophageal Reflux Disease, run by Clinica Gastrobese at 3 sites in Brazil.
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 5 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: stopped early, as of the sponsor's last update on 23 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Brazil. 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: lack of follow up). Results are not available in the source record.
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?
Occurence of gastroesophageal reflux disease (time frame: march 2010 to march 2014). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01212835, which also lists 1 linked publication.
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 23 Dec 2015.