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Completed

NCT Number: NCT01933867

Water-aided Colonoscopy in Inflammatory Bowel Disease Patients

Water-aided insertion of the colonoscope has been repeatedly proven to beneficial in terms of lower discomfort and need for sedation during colonoscopy. Patients with inflammatory bowel diseases (IBD) undergo repeated colonoscopy in course of their disease. According to our preliminary experience, water immersion could be beneficial while scoping these patients. As far as the investigators know, water-aided colonoscopy has never been studied in this indication. Results of our trial might support use of water-aided colonoscopy in common practice and decrease associated discomfort in IBD patients.

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Key information

Conditions

Inflammatory Bowel Disease Colitis Colitis, Ulcerative Colonic Diseases Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Digestive Diseases Center, Vitkovice Hospital

Ostrava, 703 84, Czechia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • known diagnosis of inflammatory bowel disease
  • planned diagnostic outpatient colonoscopy
  • signed informed consent
  • willingness to undergo unsedated colonoscopy

Exclusion criteria

  • ulcerative proctitis
  • bowel resection longer than ileocecal resection
  • requirement for sedation

Treatment and study plan

Water immersion

Procedure

Water immersion means infusion of room temperature water during colonoscope insertion without air insufflation.

Air insufflation insertion

Procedure

Other names: Room air insufflation during colonoscope insertion.

Primary outcomes

  1. Success rate of unsedated colonoscopy

    Time frame: at the end of each colonoscopy

    Successful unsedated colonoscopy is defined as reaching the cecum by using given insertion technique without administering sedation.

Secondary outcomes

  1. Discomfort during colonoscopy

    Time frame: at the end of each colonoscopy

    Discomfort level using visual continuous scale 0-10 (0 = no pain, 10 = worst pain).

  2. Cecal intubation time

    Time frame: while reaching the cecum

    Cecal intubation time is defined as time between colonoscope introduction into the anus and reaching the cecum.

Sponsors and collaborators

Lead sponsor

Vitkovice Hospital

Other

Registry information

Official study title

Water-aided Colonoscopy in Patients With Inflammatory Bowel Disease - a Single-center, Single-blinded Randomized Trial

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Sep 2, 2013
Registry last updated
Nov 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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