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Completed

NCT Number: NCT01547247

Cap-assisted Water Immersion Versus Water Immersion Colonoscopy

Water immersion insertion has been documented to decrease procedure-related discomfort during colonoscopy. Cap attached to the colonoscope tip may improve insertion and shorten cecal intubation time. The investigators would like to assess whether combination of cap-fitted colonoscopy and water immersion insertion is feasible and safe method of diagnostic colonoscopy. The primary endpoint is cecal intubation time and the investigators suppose that the use of cap is able to shorten it significantly. Patient comfort during colonoscope insertion, water consumption, length of the scope while reaching the cecum, need for external compression, need for positioning of the patient and endoscopist´s difficulty with colonoscopy are assessed.

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Key information

Conditions

Colonoscopy

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

  • outpatient diagnostic colonoscopy
  • bowel prep with macrogolum
  • initial 2 mg of midazolam i.v.
  • signed informed consent form

Exclusion criteria

  • planned therapeutic intervention
  • colorectal surgery in history
  • known inflammatory bowel disease or colorectal cancer
  • refusal of sedation

Treatment and study plan

soft straight distal cap D-201-14304 Olympus attached to the tip of the colonoscope

Device

Colonoscopy with transparent cap attached to the tip of the colonoscope and water immersion during insertion phase and romm air insufflation during colonoscope withdrawal.

water immersion colonoscopy

Procedure

Colonoscopy without transparent cap using water immersion during insertion phase and romm air insufflation during colonoscope withdrawal.

Primary outcomes

  1. Cecal Intubation Time

    Time frame: 3 months

    The primary endpoint (cecal intubation time) was defined as a time between introduction of the colonoscope into the anus and reaching the cecum.

Secondary outcomes

  1. Patient Comfort During Insertion Phase of the Colonoscopy

    Time frame: 3 months

  2. Success Rate of Minimal Sedation Colonoscopy

    Time frame: 3 months

    A successful minimal sedation colonoscopy was defined as reaching the cecum without switching to another insertion method and without additional sedation beyond the initial 2 mg of midazolam.

Sponsors and collaborators

Lead sponsor

Vitkovice Hospital

Other

Registry information

Official study title

Cap-assisted Water Immersion Versus Water Immersion Minimal Sedation Colonoscopy - a Prospective, Randomized, Single-center Trial

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Mar 7, 2012
Registry last updated
Oct 23, 2015

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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