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Carbon Dioxide Insufflation Colonoscopy in IBD Patients

V

Vitkovice Hospital

Status

Completed

Conditions

Inflammatory Bowel Disease
Carbon Dioxide
Colonoscopy

Treatments

Procedure: Carbon dioxide insufflation

Study type

Interventional

Funder types

Other

Identifiers

NCT02563132
DDC VN 08

Details and patient eligibility

About

Carbon dioxide insufflation during colonoscopy significantly reduces discomfort (pain, bloating and flatulence) after the procedure. So far, it has not been studied in inflammatory bowel disease patients. The study was designed to evaluate discomfort after the carbon dioxide insufflation colonoscopy in comparison to standard air insufflation colonoscopy.

Full description

Carbon dioxide insufflation during colonoscopy significantly reduces discomfort (pain, bloating and flatulence) during up to 24 hours after the procedure. So far, it has not been studied in inflammatory bowel disease patients who represent specific patient population indicated for colonoscopy. They are characterized by younger age, structural changes of the colon including intestinal resections and need for repeated and frequently difficult procedures.The study was designed to evaluate discomfort during 24 hours after the carbon dioxide insufflation colonoscopy in comparison to standard air insufflation colonoscopy.

Enrollment

64 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • known diagnosis of Crohn´s disease and ulcerative colitis
  • indication for diagnostic colonoscopy
  • informed consent
  • unsedated or minimally sedated procedure (< 3 mg of midazolam)

Exclusion criteria

  • planned incomplete or therapeutic procedure
  • deep sedation or general anesthesia
  • intestinal resection longer than ileocecal resection
  • isolated gastroduodenal or jejunal location of Crohn´s disease (L4)
  • ulcerative proctitis (E1)

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

64 participants in 2 patient groups

Carbon dioxide insufflation colonoscopy (CO2)
Experimental group
Description:
Carbon dioxide during both insertion and withdrawal phase of the colonoscopy.
Treatment:
Procedure: Carbon dioxide insufflation
Air insufflation colonoscopy (AI)
No Intervention group
Description:
Air insufflation during both insertion and withdrawal phase of the colonoscopy.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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