Endoscopic Argon Plasma Coagulation Vs. Control For Weight Regain After Gastric Surgery
|ClinicalTrials.gov Identifier: NCT03055754|
Recruitment Status : Completed
First Posted : February 16, 2017
Last Update Posted : May 29, 2019
|Condition or disease||Intervention/treatment||Phase|
|Obesity Weight Gain||Procedure: Argon randomized arm Procedure: Control arm||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||42 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Endoscopic Argon Plasma Coagulation Vs. Observation In The Management Of Weight Regain After Gastric Bypass Surgery: A Randomized Controlled Trial|
|Study Start Date :||May 2016|
|Actual Primary Completion Date :||February 2017|
|Actual Study Completion Date :||April 1, 2019|
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).
Procedure: Argon randomized arm
Endoscopic argon plasma coagulation
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).
Procedure: Control arm
No Endoscopic procedure
- Weight regain [ Time Frame: 48 weeks ]
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03055754
|Kaiser Clinic and Day Hospital|
|Sao Jose do Rio Preto, SP, Brazil, 15015-110|
|Principal Investigator:||Luiz G de Quadros, MD||Kaiser Clinic and Hospital|