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

NCT01370928 | Completed Phase 3

• 1 other identifier: PCF-Y0014-L
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colorectal Cancer; Adenomas

Keywords

Colonoscopy performance; Pain; Discomfort; Screening; Colorectal cancer; Colorectal cancer screening, diagnostics of adenomas

Outcome Measures

Primary Outcomes (1)

• Patients´ evaluation of pain and discomfort

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

  24 hours

Secondary Outcomes (4)

• Time used to reach the caecum

  1 hour

• Need for sedation/analgesics during the colonoscopy procedure

  1 hour

• Need to change to a different colonoscope to complete the procedure

  10 minutes

• Caecum intubation rate

  30 minutes

Study Arms (2)

Prototype colonoscope

EXPERIMENTAL

The new colonoscope to be tested

Device: Olympus PCF-Y0014-L

Standard colonoscope

ACTIVE COMPARATOR

The standard colonoscope used world-wide today.

Device: Standard colonoscope

Interventions

Olympus PCF-Y0014-L DEVICE

Screening colonoscopy with a prototype colonoscope

Also known as: Olympus PCF-Y0014-L colonoscope

Prototype colonoscope

Standard colonoscope DEVICE

Screening colonoscopy

Also known as: Olympus series 160 colonoscope

Standard colonoscope

Eligibility Criteria

• Age: 54 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• For information about the NordICC trial see clinicaltrials.gov NCT00883792

You may not qualify if:

• 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

Sponsors & Collaborators

• Sorlandet Hospital HF: lead

Study Sites (1)

Sørlandet Sykehus HF

Kristiansand, 4604, Norway

Location

Related Publications (1)

• Garborg KK, Loberg M, Matre J, Holme O, Kalager M, Hoff G, Bretthauer M. Reduced pain during screening colonoscopy with an ultrathin colonoscope: a randomized controlled trial. Endoscopy. 2012 Aug;44(8):740-6. doi: 10.1055/s-0032-1309755. Epub 2012 May 23.

  PMID: 22622786 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms; Adenoma; Pain

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael Bretthauer, MD, Ph.d.

  Oslo University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2011
• First Posted: June 10, 2011
• Study Start: March 1, 2011
• Primary Completion: June 1, 2011
• Study Completion: August 1, 2011
• Last Updated: April 27, 2012

Record last verified: 2012-04

Locations

NO (1)