Comparison Air Versus Carbon Dioxide Insufflation in Single Balloon Anterograde Enteroscopy (NCT03811522) | Clinical Trial Compass
UnknownNot Applicable
Comparison Air Versus Carbon Dioxide Insufflation in Single Balloon Anterograde Enteroscopy
United States50 participantsStarted 2019-01-01
Plain-language summary
Observation study comparing patient symptoms of bloating, pain, and nausea between CO2 insufflation vs. O2 insufflation in anterograde balloon enteroscopy.
Who can participate
Age range18 Years – 90 Years
SexALL
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Inclusion Criteria:
* All patients who presented to North Eastern Ohio Gastroenterology and Associates and meet the indications for anterograde single balloon endoscopy. Indications include small intestinal bleeding, evaluation of small bowel mass, or evaluation and treatment of small bowel strictures.
Exclusion Criteria:
* Those who wish not to participate, pregnant patients, mentally disabled individuals, prisoners, patients who have long-term analgesic use (greater than 3 months) in the past 6 months from procedure date, or those patients deemed too high risk to undergo balloon endoscopy. High risk, defined as have 3 or more of the following risk factors: chronic obstructive pulmonary disease, renal failure, morbid obesity (BMI \> 40), immuno-suppression, acquired/concurrent infection, diabetes, and chronic steroid use.
What they're measuring
1
The reduction of post operational pain
Timeframe: the survey will be asked at 15minutes, 30minutes, 1hour, and 24hours post op.
Trial details
NCT IDNCT03811522
SponsorNorth Eastern Ohio Gastroenterology and Endoscopy center