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Completed

NCT Number: NCT01370928

Colonoscopy Screening Using a Novel Slim Colonoscope - a Randomized Controlled Trial

The purpose of this study is to compare the performance of a new prototype colonoscope with a standard colonoscope used world-wide today. The prototype colonoscope is more flaccid with a smaller diameter than the standard colonoscope. The hypothesis to be tested is that the prototype will improve negotiation of sharp bends and inflict less discomfort or pain to the patient. Both colonoscopes are manufactured by the same company.

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Key information

Conditions

Colorectal Cancer Adenoma Adenomas Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Rectal Diseases Signs and Symptoms

Age range

54 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sørlandet Sykehus HF

Kristiansand, 4604, Norway

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Persons included in the NordICC trial are eligible for inclusion
  • For information about the NordICC trial see clinicaltrials.gov NCT00883792

Exclusion criteria

  • Pregnancy
  • Persons younger than 18 years
  • Persons unable to comprehend the information given
  • not possible to start the examination without prior administration of sedation/analgesics

Treatment and study plan

Olympus PCF-Y0014-L

Device

Screening colonoscopy with a prototype colonoscope

Other names: Olympus PCF-Y0014-L colonoscope

Standard colonoscope

Device

Screening colonoscopy

Other names: Olympus series 160 colonoscope

Primary outcomes

  1. Patients´ evaluation of pain and discomfort

    Time frame: 24 hours

    Analysis of validated feed-back questionnaires to be filled in on the day after the proceudre by the trial participants.

Secondary outcomes

  1. Time used to reach the caecum

    Time frame: 1 hour

    The time used to reach the caecum will be recorded with a stop watch during the procedure.

  2. Need for sedation/analgesics during the colonoscopy procedure

    Time frame: 1 hour

    If sedation/analgesics is administered during the colonoscopy procedure, the name of the agent, dose and route of administration will be recorded immediately.

  3. Need to change to a different colonoscope to complete the procedure

    Time frame: 10 minutes

    If the colonoscopist decides to change to a different colonoscope during the procedure, the reason is recorded immediately after the procedure. The number of procedures where there is a change of colonoscope will be recorded.

  4. Caecum intubation rate

    Time frame: 30 minutes

    The colonic segment reached during each colonoscopy is recorded immediately following the procedure. Caecal intubation rate describes the number of complete colonoscopies.

Sponsors and collaborators

Lead sponsor

Sorlandet Hospital HF

Other Gov

Registry information

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jun 10, 2011
Registry last updated
Apr 27, 2012

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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