NCT03055754

Brief Summary

Bariatric surgery procedures have consistently been demonstrated to reduce long-term co-morbidities and mortality. Despite its benefits, weight regain is common, usually initiating around two years after the initial procedure, the underlying mechanism often being an enlargement of the anastomosis diameter for the Roux-en-Y gastric bypass. Although a reduction in the anastomosis diameter has been reported in association with endoscopic argon plasma coagulation, to our knowledge this therapy has not been formally tested in a randomized controlled trial. the objective of this study is to conduct a randomized, parallel controlled trial comparing endoscopic argon plasma coagulation to reduce the enlargement of the anastomosis diameter for the Roux-en-Y gastric bypass versus control with an initial diagnostic endoscopic followed by observation. The investigators hypothesize that the argon coagulation arm will achieve greater weight reduction, with a low incidence of adverse events.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started May 2016

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

May 1, 2016

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 30, 2017

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 16, 2017

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

May 29, 2019

Status Verified

May 1, 2019

Enrollment Period

9 months

First QC Date

January 30, 2017

Last Update Submit

May 27, 2019

Conditions

ObesityWeight Gain

Outcome Measures

Primary Outcomes (1)

  • Weight regain

    48 weeks

Secondary Outcomes (8)

  • Gastrointestinal symptoms

    48 weeks

  • Satiety verbal analog scale

    48 weeks

  • Fasting glucose concentration in mg/dL

    48 weeks

  • HbA1c in percentage

    48 weeks

  • Arterial blood pressure in mm Hg

    48 weeks

  • +3 more secondary outcomes

Study Arms (2)

Argon randomized arm

EXPERIMENTAL

Endoscopic procedure with a full inventory, measurement of the anastomosis diameter, and an argon plasma coagulation. Followup of all patients by a multidisciplinary team (life, food orientations).

Procedure: Argon randomized arm

Control arm

ACTIVE COMPARATOR

Full inventory and measurement of the anastomosis diameter, without any intervention. Followup of all patients by a multidisciplinary team (life, food orientations).

Procedure: Control arm

Interventions

Argon randomized armPROCEDURE

Endoscopic argon plasma coagulation

Argon randomized arm
Control armPROCEDURE

No Endoscopic procedure

Control arm

Eligibility Criteria

Age16 Years - 76 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • all consecutive patients who have previously undergone a bariatric procedure
  • who present with symptoms of weight regain, difficulty maintaining weight, and lack of satiety after meals.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaiser Clinic and Day Hospital

São José do Rio Preto, São Paulo, 15015-110, Brazil

Location

Related Publications (1)

  • Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials. Obstet Gynecol. 2010 May;115(5):1063-1070. doi: 10.1097/AOG.0b013e3181d9d421. No abstract available.

    PMID: 20410783BACKGROUND

MeSH Terms

Conditions

ObesityWeight Gain

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Officials

  • Luiz G de Quadros, MD

    Kaiser Clinic and Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2017

First Posted

February 16, 2017

Study Start

May 1, 2016

Primary Completion

February 1, 2017

Study Completion

April 1, 2019

Last Updated

May 29, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will share

Locations

BR(1)