Effect of RING on Gastroesophageal Reflux (GERD) After RYGBP

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Carlos AS Madalosso, Clinica Gastrobese
ClinicalTrials.gov Identifier:
NCT01212835
First received: September 29, 2010
Last updated: August 13, 2013
Last verified: August 2013
  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: October 2010
Estimated Study Completion Date: November 2014
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01212835

Locations
Brazil
Clínica Gastrobese
Passo Fundo, RS, Brazil, 99010112
Gastrobese Clinic
Passo Fundo, RS, Brazil, 99020000
Hospital Sao Vicente de Paulo
Passo Fundo, RS, Brazil, 99020000
Sponsors and Collaborators
Clinica Gastrobese
Investigators
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 Director: Fabio R Barao, Admn Protocol control
  More Information

Publications:
Responsible Party: Carlos AS Madalosso, Clinica Gastrobese
ClinicalTrials.gov Identifier: NCT01212835     History of Changes
Other Study ID Numbers: GASTROBESE 005
Study First Received: September 29, 2010
Last Updated: August 13, 2013
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:
Gastroesophageal Reflux
Obesity
Obesity, Morbid
Body Weight
Deglutition Disorders
Digestive System Diseases
Esophageal Diseases
Esophageal Motility Disorders
Gastrointestinal Diseases
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on October 22, 2014