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

September 29, 2010
August 13, 2013
October 2010
March 2012   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01212835 on ClinicalTrials.gov Archive Site
  • 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.
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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
114
November 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
Both
18 Years to 58 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01212835
GASTROBESE 005
No
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
August 2013

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