Effect of RING on Gastroesophageal Reflux (GERD) After RYGBP
This study is currently recruiting participants.
Verified October 2010 by Clinica Gastrobese
Sponsor:
Clinica Gastrobese
Information provided by:
Clinica Gastrobese
ClinicalTrials.gov Identifier:
NCT01212835
First received: September 29, 2010
Last updated: October 1, 2010
Last verified: October 2010
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Morbid Obesity Gastroesophageal Reflux Disease Vomiting |
Procedure: Sham Comparator: no ring Procedure: RYGBP-RING |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | The Use of a Silastic Ring in Open Gastric Bypass for Morbid Obesity and Its Association With Gastroesophageal Reflux Disease |
Resource links provided by NLM:
Further study details as provided by Clinica Gastrobese:
Primary Outcome Measures:
- Occurence of gastroesophageal reflux disease [ Time Frame: march 2010 to march 2014 ] [ Designated as safety issue: No ]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.
Secondary Outcome Measures:
- The role of the ring in open GBP in terms of weight loss [ Time Frame: march 2010 to march 2014 ] [ Designated as safety issue: No ]It will be possible to evaluate the weight loss among the groups: 1) with ring and, 2) without a ring
- The impact of the ring on food tolerance [ Time Frame: March 2010 to March 2014 ] [ Designated as safety issue: No ]To identify food intolerance among the groups: 1) with the ring, and 2) without the ring.
| Estimated Enrollment: | 114 |
| Study Start Date: | March 2010 |
| Estimated Study Completion Date: | November 2014 |
| Estimated Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Sham Comparator: no ring
Patients at this group will have RING REMOVED AT THE END OF SURGERY.
|
Procedure: Sham Comparator: no ring
Open roux-en-Y gastric bypass not banded
|
|
Active Comparator: RYGBP-Ring
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.
|
Procedure: RYGBP-RING
Vertical Roux-en-Y banded gastric bypass
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 58 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Inferior and superior total teeth prosthesis
- Poor surgical conditions
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01212835
Contacts
| Contact: Madalosso CA Madalosso, MD | 555496253605 | madalosso@gastrobese.com.br |
| Contact: Vera Lunardelli, Manager | 555430454070 | contato@gastrobese.com.br |
Locations
| Brazil | |
| Clínica Gastrobese | Recruiting |
| Passo Fundo, RS, Brazil, 99010112 | |
| Contact: Carlos AS Madalosso, MD 55.54.33116922 Contato@gastrobese.com.br | |
| Principal Investigator: Carlos AS Madalosso, MD | |
| Sub-Investigator: Iran Moraes Jr, M.D. | |
| Sub-Investigator: Danie Navarini, M.D. | |
| Sub-Investigator: Fernando Fornari, Ph.D. | |
| Sub-Investigator: Luis A Palma, M.D. | |
| Gastrobese Clinic | Recruiting |
| Passo Fundo, RS, Brazil, 99020000 | |
| Contact: Vera B Lunardelli, Manager 555430454070 contato@gastrobese.com.br | |
| Contact: Andrea Rossato, Secretary 555430454070 contato@gastrobese.com.br | |
| Principal Investigator: Carlos AS Madalosso, M.D. | |
| Hospital Sao Vicente de Paulo | Recruiting |
| Passo Fundo, RS, Brazil, 99020000 | |
| Contact: Carlos AS Madalosso, M.D. 55 54 9625 3605 | |
| Contact: Vera B Lunardelli, M.D. 55 54 9983 1330 | |
Sponsors and Collaborators
Clinica Gastrobese
Investigators
| Study Director: | Carlos AS Madalosso, M.D. | Hospital de Ensino Sao Vicente de Paulo, Passo Fundo - RS; Brazil |
| Study Chair: | Daniel Navarini, M.D. | Clinica Gastrobese |
| Principal Investigator: | Carlos AS Madalosso, M.D. | Clinica Gastrobese |
| Study Chair: | Iran Moraes Jr, M.D. | Clinica Gastrobese |
| Study Chair: | Luis A Palma, M.D. | Clinica Gastrobese |
| Study Chair: | Fernando Fornari, M.D. | Faculadade de Medicina - UPF |
More Information
Publications:
| Responsible Party: | Carlos Augusto S. Madalosso, Clinica Gastrobese |
| ClinicalTrials.gov Identifier: | NCT01212835 History of Changes |
| Other Study ID Numbers: | GASTROBESE 005 |
| Study First Received: | September 29, 2010 |
| Last Updated: | October 1, 2010 |
| Health Authority: | Brazil: National Health Surveillance Agency |
Keywords provided by Clinica Gastrobese:
|
Obesity gastroesophageal reflux disease Morbid obesity esophagitis |
GERD silastic ring Gastric bypass |
Additional relevant MeSH terms:
|
Obesity, Morbid Gastroesophageal Reflux Obesity Vomiting Esophageal Motility Disorders Deglutition Disorders Esophageal Diseases Gastrointestinal Diseases |
Digestive System Diseases Overnutrition Nutrition Disorders Overweight Body Weight Signs and Symptoms Signs and Symptoms, Digestive |
ClinicalTrials.gov processed this record on May 16, 2013