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

NCT03264027 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2022-08-17

No results posted yet for this study

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

Interventions

DRUG

Carbon dioxide

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

DRUG

Ambient air

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

DRUG

Argon fulguration

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).

Sponsors & Collaborators

  • Kaiser Clinic and Hospital

    lead OTHER

Principal Investigators

  • Luiz G Quadros, MD · Kaiser Clinic and Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-06
Primary Completion
2020-01-12
Completion
2020-01-12

Countries

  • Brazil

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03264027 on ClinicalTrials.gov