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Completed

NCT Number: NCT00153647

A Study to Assess Cap-Assisted Colonoscopy Versus Regular Colonoscopy for the First or Repeated Colonoscopy

The primary aim of the study is to increase the success rate of cecal intubation in first colonoscopy and in repeated colonoscopy for the first failed procedure. The secondary aims are to assess the procedure time, the terminal ileum intubation rate, the endoscopist satisfaction score, the patients' acceptance, the complication rate of these two procedures, and the intravenous sedative drugs used.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Endoscopy Center, Alice Ho Miu Ling Nethersole Hospital, Hong Kong, China

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About this study

Currently there is no consensus in how to improve the success rate of colonoscopy procedure given the fact that 10% of the procedures may fail. It has been suggested that using variable stiffness colonoscope (a colonoscope with a shaft that the stiffness can be altered), or even more sophisticated magnetic imaging colonoscopy (colonoscopy performed under a magnetic position detection sensor), could improve the success rate. However, these kinds of equipment are either expensive or not always available in the daily clinical practice. From some recent studies it was shown that adding a transparent cap to the tip of the colonoscope may improve the procedure success rate without increasing the complication rate of the procedure. The cost of the cap is cheap and it is available in almost every endoscopy center. Therefore the cap-assisted colonoscopy method may be an alternative which may improve the success rate of colonoscopy procedure, and reduce the pain and discomfort related to the procedure.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients who undergo their first colonoscopy examination

Exclusion criteria

  • Patients had received colonoscopy examination before
  • Patients had prior colorectal surgery done (apart from appendectomy)
  • Known to have colonic stricture or obstructing tumor from the results of other investigations such as CT scan or barium enema
  • Presence of acute surgical conditions such as severe colitis, megacolon, ischemic colitis and active gastrointestinal bleeding

Treatment and study plan

Cap-assisted colonoscopy

Procedure

Cap-assisted colonoscopy

Primary outcomes

  1. The success rate of cecal intubation

    Time frame: 24 hours

Secondary outcomes

  1. The procedure time to achieve cecal intubation

    Time frame: 24 hours

  2. Success rate in achieving terminal ileum intubation

    Time frame: 24 hours

  3. The procedure time to achieve terminal ileum intubation

    Time frame: 24 hours

  4. Complications related to the procedure

    Time frame: 24 hours

  5. The procedure difficulty as assessed by the endoscopist using a 10 cm visual analog scale

    Time frame: 24 hours

  6. The procedure difficulty of polypectomy if indicated as assessed by the endoscopist using a 10 cm visual analog scale

    Time frame: 24 hours

  7. The patient's pain score as assessed by the patient using a visual analog scale right after he regains full consciousness, which is assessed by accurately performing a deduction test (100 minus 7 test, correct for three deductions), before discharge

    Time frame: 24 hours

  8. The dose of the intravenous drugs used

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

A Study to Assess the Success Rate of Cap-Assisted Colonoscopy Versus Regular Colonoscopy for the First or Repeated Colonoscopy (CAC Study)

Acronym: CAC

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Sep 12, 2005
Registry last updated
Mar 18, 2008

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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