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

NCT03264027 | Completed

• 1 other identifier: kaiserargongjanastomosis
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Conditions

Dilatation of Anastomosis; Bypass Complication; Obesity

Outcome Measures

Primary Outcomes (1)

• Change in Pain Visual Analogue Scale

  A visual scale to assess self-reported pain going from 0 to 10.

  Before surgery, and after eight weeks of the first endoscopic session. The outcome will be the substraction of the initial value and the final value of pain.

Secondary Outcomes (2)

• Change in diameter of the gastrojejunal anastomosis

  Before surgery, and after eight weeks of the first endoscopic session.

• Weight reduction

  Before surgery, and after eight weeks of the first endoscopic session.

Study Arms (2)

Carbon dioxide

EXPERIMENTAL

Argon fulguration will be performed using CO2 for insufflation. After using a disposable endoscopic catheter, argon plasma (Argon 2) (MAE, Ribeirão Preto, Brazil) will be applied in a 1-cm band around the entire circumference of the gastrojejunal anastomosis at an intensity of 90 W and a flow rate of 2 L/min.

Drug: Carbon dioxide; Drug: Argon fulguration

Ambient air

ACTIVE COMPARATOR

Argon fulguration will be performed using ambient air for insufflation. After using a disposable endoscopic catheter, argon plasma (Argon 2) (MAE, Ribeirão Preto, Brazil) will be applied in a 1-cm band around the entire circumference of the gastrojejunal anastomosis at an intensity of 90 W and a flow rate of 2 L/min.

Drug: Ambient air; Drug: Argon fulguration

Interventions

Carbon dioxide DRUG

Carbon dioxide will be used as an insufflating gas during argon fulguration of the dilatated anastomosis.

Also known as: Carbon dioxide insufflation

Carbon dioxide

Ambient air DRUG

Ambient air will be used as an insufflating gas during argon fulguration of the dilatated anastomosis.

Also known as: Ambient air insuflattion

Ambient air

Argon fulguration DRUG

The dilatated anastomosis from the gastric bypass surgery will be reduced in diameter using fulguration with argon. Patient in both groups will be placed in the left lateral decubitus position, with anesthesia being performed exclusively using propofol; adequate cardiopulmonary monitoring will be carried out during the entire procedure. After sedation, endoscopy will be performed with an Olympus CV-180 endoscope (Olympus, Tokyo, Japan) and analysis and measurement of the anastomosis will be achieved using Raptor foreign body forceps (Endoscopy Group US, Inc., Mentor - Ohio, USA). The images will be transferred to an Olympus EvisExera II processor connected to a computer with the ZScan 5 program (Goiânia, GO, Brazil).

Also known as: Argon

Ambient air; Carbon dioxide

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Kaiser Clinic and Hospital: lead

Study Sites (1)

Kaiser Clinic and Day Hospital

São José Do Rio Prêto, São Paulo, 15015-110, Brazil

Location

Related Publications (1)

• Baretta GA, Alhinho HC, Matias JE, Marchesini JB, de Lima JH, Empinotti C, Campos JM. Argon plasma coagulation of gastrojejunal anastomosis for weight regain after gastric bypass. Obes Surg. 2015 Jan;25(1):72-9. doi: 10.1007/s11695-014-1363-2.

  PMID: 25005812 BACKGROUND

MeSH Terms

Conditions

Obesity

Interventions

Carbon Dioxide; Particulate Matter; Argon

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Carbon Compounds, Inorganic; Inorganic Chemicals; Gases; Oxides; Oxygen Compounds; Complex Mixtures; Noble Gases; Elements

Study Officials

• Luiz G Quadros, MD

  Kaiser Clinic and Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Both the participant and the outcome assessor will be blinded to the study intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 3, 2017
• First Posted: August 28, 2017
• Study Start: January 6, 2017
• Primary Completion: January 12, 2020
• Study Completion: January 12, 2020
• Last Updated: August 17, 2022

Record last verified: 2022-08

Locations

BR (1)