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Endoscopic Argon Plasma Coagulation Vs. Control For Weight Regain After Gastric Surgery

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.
 
ClinicalTrials.gov Identifier: NCT03055754
Recruitment Status : Completed
First Posted : February 16, 2017
Last Update Posted : May 29, 2019
Sponsor:
Information provided by (Responsible Party):
Kaiser Clinic and Hospital

Tracking Information
First Submitted Date  ICMJE January 30, 2017
First Posted Date  ICMJE February 16, 2017
Last Update Posted Date May 29, 2019
Study Start Date  ICMJE May 2016
Actual Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 14, 2017)
Weight regain [ Time Frame: 48 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 27, 2019)
  • Gastrointestinal symptoms [ Time Frame: 48 weeks ]
    Symptoms like Nausea, Vomiting, Cramps in stomach
  • Satiety verbal analog scale [ Time Frame: 48 weeks ]
  • Fasting glucose concentration in mg/dL [ Time Frame: 48 weeks ]
  • HbA1c in percentage [ Time Frame: 48 weeks ]
  • Arterial blood pressure in mm Hg [ Time Frame: 48 weeks ]
  • plasma total cholesterol, HDL cholesterol and triglycerides (mg/dL) [ Time Frame: 48 weeks ]
  • Quality of life of patient [ Time Frame: 48 weeks ]
    Quality of life measured using EQ-5D scale
  • Surgical and diabetes-related complications [ Time Frame: 48 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 14, 2017)
  • Gastrointestinal symptoms [ Time Frame: 48 weeks ]
    Symptoms like Nausea, Vomiting, Cramps in stomach
  • Satiety verbal analog scale [ Time Frame: 48 weeks ]
  • Fasting glucose concentration in mg/dL [ Time Frame: 48 weeks ]
  • HbA1c in percentage [ Time Frame: 48 weeks ]
  • Arterial blood pressure in mm Hg [ Time Frame: 48 weeks ]
  • plasma total cholesterol, HDL cholesterol and triglycerides (mg/dL) [ Time Frame: 48 weeks ]
  • Quality of life [ Time Frame: 48 weeks ]
    Quality of life measured using EQ-5D scale
  • Surgical and diabetes-related complications [ Time Frame: 48 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Endoscopic Argon Plasma Coagulation Vs. Control For Weight Regain After Gastric Surgery
Official Title  ICMJE Endoscopic Argon Plasma Coagulation Vs. Observation In The Management Of Weight Regain After Gastric Bypass Surgery: A Randomized Controlled Trial
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.
Detailed Description

This will be a parallel randomized controlled trial with a 1:1 allocation ratio, 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 study is designed and reported in accordance with the CONSORT statement for parallel randomized trials. Eventual changes made to the design after trial commencement will be fully reported, including changes in eligibility criteria throughout the study.

Ethical aspects: The study will undergo full review by the local Institutional Review Board, all potential participants being provided with informed consent. Study protocol will only be initiated after consent is signed.

Participants: Inclusion criteria will involve all consecutive patients who have previously undergone a bariatric procedure and who now present with symptoms of weight regain, difficulty maintaining weight, and lack of satiety after meals. The investigator will not exclude any patients meeting these criteria. No other treatments will be provided. A total of 40 participants will be part of this analysis, or 20 per randomization arm.

Setting: Data will be collected at the Kaiser Clinic in São José do Rio Preto, Brazil. Participant accrual will start in April of 2016, with the end of follow-up occurring around the end of 2017.

Interventions: Interventions for the argon randomized arm will include an endoscopic procedure with a full inventory, measurement of the anastomosis diameter, and an argon plasma coagulation. The control arm will only undergo a full inventory and measurement of the anastomosis diameter, without any intervention. Participants allocated to the observational arm and presenting with continued symptoms of weight regain, difficulty maintaining weight, and lack of satiety after meals will not be prevented from undergoing an argon intervention, although our analyses will still analyze their results within the observation arm, thus observing an intention to treat protocol.

Outcomes: Primary outcomes of interested will be weight regain, gastrointestinal symptoms, and satiety verbal analog scale. Secondary outcome measures will include fasting glucose concentration, HbA1c concentration, body weight, body mass index, waist circumference, arterial blood pressure, plasma total cholesterol, HDL cholesterol and triglycerides, quality of life, surgical complications, and diabetes-related complications.

Sample size: The sample size is estimated to be 40 participants total, or 20 in each randomization arm.

Randomization: The random sequence will be generated using the statistical language R by a researcher not involved with subject allocation. The randomization schedule has a blocking size of an undisclosed size, with no stratification. Randomization will be implemented by an administrative assistant using sealed, sequentially numbered envelopes. Researchers will be specifically instructed not to attempt to break the randomization schedule in any manner. Subject allocation will be performed by the principal investigator (GQ) soon after consent and prior to the endoscopic procedure. Given the nature of this intervention, the only individual blinded regarding randomization will be the data analyst. Blinding will be ensured by having codes in the final dataset.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Obesity
  • Weight Gain
Intervention  ICMJE
  • Procedure: Argon randomized arm
    Endoscopic argon plasma coagulation
  • Procedure: Control arm
    No Endoscopic procedure
Study Arms  ICMJE
  • Experimental: Argon randomized arm
    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).
    Intervention: Procedure: Argon randomized arm
  • Active Comparator: Control arm
    Full inventory and measurement of the anastomosis diameter, without any intervention. Followup of all patients by a multidisciplinary team (life, food orientations).
    Intervention: Procedure: Control arm
Publications * 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):1063-70. doi: 10.1097/AOG.0b013e3181d9d421.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 4, 2017)
42
Original Estimated Enrollment  ICMJE
 (submitted: February 14, 2017)
40
Actual Study Completion Date  ICMJE April 1, 2019
Actual Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.

Exclusion Criteria:

-

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 76 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03055754
Other Study ID Numbers  ICMJE KaiserCH
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party Kaiser Clinic and Hospital
Study Sponsor  ICMJE Kaiser Clinic and Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Luiz G de Quadros, MD Kaiser Clinic and Hospital
PRS Account Kaiser Clinic and Hospital
Verification Date May 2019

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