Status:
COMPLETED
Carbon Dioxide Versus Air Insufflation for the Application of Argon Plasma to Reduce the Gastrojejunal Anastomosis
Lead Sponsor:
Kaiser Clinic and Hospital
Conditions:
Dilatation of Anastomosis
Bypass Complication
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The objective of this randomized clinical trial is to compare pain levels during and after insufflation with carbon dioxide or in subjects that will undergo endoscopic fulguration with argon to reduce...
Detailed Description
Laparoscopic gastric bypass surgery is one of the strategies oriented towards weight reduction in obese patients. Although in the short term it has a high degree of success, weight regain is common in...
Eligibility Criteria
Inclusion
- Regain of at least 10.0% of the minimum weight reached after the gastric bypass;
- Ability to understand study procedures;
- Signed the informed written consent form;
- Possible to complete all the stages of the study.
Exclusion
- Presence of very tight restrictive ring preventing the advancement of the endoscopy device;
- Stenosis of the anastomosis preventing the progression of the endoscopy device before the end of the three endoscopic sessions;
- History of liver diseases such as cirrhosis or chronic active hepatitis;
- Patients who required anticoagulant therapy with the exception of antiplatelet agents;
- Pregnant women or those intending to become pregnant within 12 months after fulguration with argon;
- Participant in another ongoing clinical research;
- Recent history of neoplasia (less than 5 years);
- Alcoholism or drug use;
- HIV positive;
- Unbalanced or uncontrollable psychiatric disorders;
- Anemia or severe nutritional deficiencies;
- Allergy to anesthetic compounds;
- Impossibility to return within defined periods for consultations and endoscopic sessions of fulguration with argon;
- Inability to follow nutritional guidelines after each endoscopic session;
- Inability to understand study procedures;
Key Trial Info
Start Date :
January 6 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 12 2020
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT03264027
Start Date
January 6 2017
End Date
January 12 2020
Last Update
August 17 2022
Active Locations (1)
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1
Kaiser Clinic and Day Hospital
São José Do Rio Prêto, São Paulo, Brazil, 15015-110