ObesityNCT03055754
Endoscopic Argon Plasma Coagulation Vs. Control For Weight Regain After Gastric Surgery
A study testing Argon randomized arm in people with Obesity and Weight Gain, run by Kaiser Clinic and Hospital at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 to 76 years
- Conditions the study is for
- Obesity, Weight Gain
- What is being tested?
- Argon randomized arm
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteBrazil
- Study dates
- May 2016to 1 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 76 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Kaiser Clinic and Day Hospital
São José do Rio Preto, São Paulo, 15015-110
About this study
Official title: Endoscopic Argon Plasma Coagulation Vs. Observation In The Management Of Weight Regain After Gastric Bypass Surgery: A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Obesity, Weight Gain
- Being tested
- Argon randomized arm, Control arm
- Medical subject headings
- Obesity, Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Argon randomized armProcedure or surgery
Endoscopic argon plasma coagulation
Control armProcedure or surgery
No Endoscopic procedure
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Procedure: Control arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight regain
Measured: 48 weeks
Secondary outcomes (8)
Gastrointestinal symptoms
Symptoms like Nausea, Vomiting, Cramps in stomach
Measured: 48 weeks
Satiety verbal analog scale
Measured: 48 weeks
Fasting glucose concentration in mg/dL
Measured: 48 weeks
HbA1c in percentage
Measured: 48 weeks
Arterial blood pressure in mm Hg
Measured: 48 weeks
plasma total cholesterol, HDL cholesterol and triglycerides (mg/dL)
Measured: 48 weeks
Quality of life of patient
Quality of life measured using EQ-5D scale
Measured: 48 weeks
Surgical and diabetes-related complications
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2017
- Study startMay 2016
- Primary completionFeb 2017
- Study completion1 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Clinic and Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luiz G de Quadros, MD, Principal investigator, Kaiser Clinic and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03055754
- Sponsor's protocol ID
- KaiserCH
- Status last verified
- May 2019
- First submitted
- 30 Jan 2017
- Last updated
- 29 May 2019
- Results posted
- No
- Individual data sharing
- Yes
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):1063-1070. doi: 10.1097/AOG.0b013e3181d9d421. No abstract available.
PubMed 20410783
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Argon Plasma Coagulation Vs. Observation In The Management Of Weight Regain After Gastric Bypass Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03055754
- Acronym / sponsor ID
- KaiserCH
- Conditions
- Obesity, Weight Gain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Kaiser Clinic and HospitalUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Feb 2017 (actual)
- Study completion
- 1 Apr 2019 (actual)
- First posted
- 16 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Argon randomized arm | Experimental | Procedure: Argon randomized armEndoscopic 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). |
| Control arm | Active comparator | Procedure: Control armFull inventory and measurement of the anastomosis diameter, without any intervention. Followup of all patients by a multidisciplinary team (life, food orientations). |
Who may qualify
- Ages
- 16 to 76 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Argon randomized armEndoscopic argon plasma coagulation | Procedure or surgery | Argon randomized arm |
| Control armNo Endoscopic procedure | Procedure or surgery | Control arm |
Primary outcome
Weight regain
Time frame: 48 weeks
8 secondary outcomes
Gastrointestinal symptoms
Time frame: 48 weeks
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
Surgical and diabetes-related complications
Time frame: 48 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2019.
- Background: PubMed 20410783Schulz 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luiz G de Quadros, MD principal investigator
Kaiser Clinic and Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Argon randomized arm in people with Obesity and Weight Gain, run by Kaiser Clinic and Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight regain (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03055754, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2019.