Effect of RING on Gastroesophageal Reflux (GERD) After RYGBP (RING)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01212835
Recruitment Status : Terminated (lack of follow up)
First Posted : October 1, 2010
Last Update Posted : December 23, 2015
Information provided by (Responsible Party):
Carlos AS Madalosso, Clinica Gastrobese

September 29, 2010
October 1, 2010
December 23, 2015
October 2010
March 2012   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01212835 on Archive Site
  • The role of the ring in open GBP in terms of weight loss [ Time Frame: march 2010 to march 2014 ]
    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 ]
    To identify food intolerance among the groups: 1) with the ring, and 2) without the ring.
Same as current
Not Provided
Not Provided
Effect of RING on Gastroesophageal Reflux (GERD) After RYGBP
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.
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.
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Morbid Obesity
  • Gastroesophageal Reflux Disease
  • Vomiting
  • Procedure: Sham Comparator: no ring
    Open roux-en-Y gastric bypass not banded
  • Procedure: RYGBP-RING
    Vertical Roux-en-Y banded gastric bypass
  • Sham Comparator: no ring
    Patients at this group will have RING REMOVED AT THE END OF SURGERY.
    Intervention: Procedure: Sham Comparator: no ring
  • 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.
    Intervention: Procedure: RYGBP-RING
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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
January 2014
March 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 58 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Carlos AS Madalosso, Clinica Gastrobese
Clinica Gastrobese
Not Provided
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
Clinica Gastrobese
December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP