NCT01212835

Brief 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. The investigators hypothesized that the use of a silastic ring may play a role in promoting GERD after this operation.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
114

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 29, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 1, 2010

Completed
Same day until next milestone

Study Start

First participant enrolled

October 1, 2010

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

December 23, 2015

Status Verified

December 1, 2015

Enrollment Period

1.4 years

First QC Date

September 29, 2010

Last Update Submit

December 21, 2015

Conditions

Morbid ObesityGastroesophageal Reflux DiseaseVomiting

Keywords

Obesitygastroesophageal reflux diseaseMorbid obesityesophagitisGERDsilastic ringGastric bypass

Outcome Measures

Primary Outcomes (1)

  • 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.

    march 2010 to march 2014

Secondary Outcomes (2)

  • The role of the ring in open GBP in terms of weight loss

    march 2010 to march 2014

  • The impact of the ring on food tolerance

    March 2010 to March 2014

Study Arms (2)

no ring

SHAM COMPARATOR

Patients at this group will have RING REMOVED AT THE END OF SURGERY.

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.

Procedure: RYGBP-RING

Interventions

Sham Comparator: no ringPROCEDURE

Open roux-en-Y gastric bypass not banded

no ring
RYGBP-RINGPROCEDURE

Vertical Roux-en-Y banded gastric bypass

RYGBP-Ring

Eligibility Criteria

Age18 Years - 58 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Inferior and superior total teeth prosthesis
  • Poor surgical conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

ClĂ­nica Gastrobese

Passo Fundo, Rio Grande do Sul, 99010112, Brazil

Location

Gastrobese Clinic

Passo Fundo, Rio Grande do Sul, 99020000, Brazil

Location

Hospital Sao Vicente de Paulo

Passo Fundo, Rio Grande do Sul, 99020000, Brazil

Location

Related Publications (1)

  • 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.

    PMID: 20010088RESULT

MeSH Terms

Conditions

Obesity, MorbidGastroesophageal RefluxVomitingObesityEsophagitis

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsEsophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesSigns and Symptoms, DigestiveGastroenteritis

Study Officials

  • Daniel Navarini, M.D.

    Clinica Gastrobese

    STUDY CHAIR

  • Carlos AS Madalosso, M.D.

    Clinica Gastrobese

    PRINCIPAL INVESTIGATOR

  • Iran Moraes Jr, M.D.

    Clinica Gastrobese

    STUDY CHAIR

  • Fabio R Barao, Admn

    Protocol control

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Carlos AS Madalosso

Study Record Dates

First Submitted

September 29, 2010

First Posted

October 1, 2010

Study Start

October 1, 2010

Primary Completion

March 1, 2012

Study Completion

January 1, 2014

Last Updated

December 23, 2015

Record last verified: 2015-12

Locations

BR(3)