Carbon Dioxide Versus Air Insufflation for the Application of Argon Plasma to Reduce the Gastrojejunal Anastomosis

• Status: Unknown status
• Trial end date: 2020-01-12
• Target enrollment: 0
• Participant gender: All

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 the diameter of the gastrojejunal anastomosis. The investigators hypothesize that carbon dioxide will be superior in causing less pain and leading to less discomfort.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kaiser Clinic and Hospital

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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;