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Completed

NCT Number: NCT01582178

Warm Water Versus Room Temperature Water Immersion Colonoscopy

Water immersion insertion has been documented to decrease procedure-related discomfort during colonoscopy. There was used warm water infusion for colonoscope insertion in most of the water immersion colonoscopy trials.

The investigators have been using room temperature water (20-24°C) for water immersion and the investigators did not notice any drawback of it. In our opinion, it is simpler and cheaper option for water immersion colonoscopy and proof of its efficacy and safety could support the use of water immersion technique in routine practice.

The primary endpoint is cecal intubation time and the investigators suppose that the use of warm water infusion does not 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 will be also assessed.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal 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

  • 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

Warm Water Immersion Colonoscopy

Procedure

Colonoscopy using warm water (37°C) infusion for colonoscope insertion and room air insufflation during colonoscope withdrawal.

Cool Water Immersion Colonoscopy

Procedure

Colonoscopy using room temperature water (20-24°C) infusion for colonoscope insertion and room air insufflation during colonoscope withdrawal.

Primary outcomes

  1. Cecal Intubation Time

    Time frame: 3 months

  2. Cecal Intubation Time

    Time frame: 1-30

    = 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

Sponsors and collaborators

Lead sponsor

Vitkovice Hospital

Other

Registry information

Official study title

Warm Water Versus Room Temperature Water Immersion Colonoscopy - a Prospective, Randomized, Double-blind, Single-center Trial

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Apr 20, 2012
Registry last updated
Sep 20, 2013

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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