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OpenTrials
Completed

NCT Number: NCT01989650

The Effect of Taking Break During Colonoscopy Session on Adenoma Detection, a Prospective, Randomized Control Study

Recent research has suggested that endoscopist fatigue may significantly affect the polyp detection rate. There have been no studies on interventions that may reduce endoscopist fatigue and therefore improve colonoscopy performance.

We want to determine whether a break in the middle of colonoscopy session would maintain a more stable adenoma detection rate

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alice Ho Miu Ling Nethersole Hospital

Hong Kong

About this study

In recent years, there has been a dramatic increase in the volume of endoscopic procedures performed in most endoscopy centers. With the growing awareness of colorectal cancer screening, there is increasing demand for colonoscopy which has increased the workload of endoscopists in every healthcare system. There are studies showing that physician fatigue impairs quality of care and performance in other medical specialties such as anesthesia and surgery. Colonoscopy by nature is repetitive and frequently prolonged which can promote distractibility and fatigability. Studies from western countries have showed that afternoon colonoscopies are associated with lower adenoma detection rate (ADR) compared with the morning colonoscopies and physician fatigue has been hypothesized as a potential contributor. Previous studies also showed that the polyp detection rate decreases hour-by-hour throughout the day and the colonoscopy completion rate appears to decline with successive procedures due to endoscopist fatigue. The most recent study using the queue position as a surrogate marker for endoscopist fatigue had showed that both the later colonoscopy start time and increasing number of preceding endoscopic procedures are associated with decreasing polyp detection rate. It is not surprising that endoscopist fatigue may contribute to a significant decline in the effectiveness of colonoscopy and yet it is probably not realistic to reduce the number of colonoscopy procedures per session given the heavy clinical demand. There have been no studies on any intervention that may improve the performance of colonoscopy. It would be reasonable to postulate that taking a break half way through the colonoscopy session may alleviate endoscopist fatigue and hence improve the polyp detection rate. This study aims to evaluate the effect of introducing a break in the middle of a colonoscopy session on the quality of colonoscopy performance.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • All patients who underwent colonoscopies in the afternoon session at the endoscopy unit in AHNH were eligible for inclusion in this study.

Exclusion criteria

  • Emergency inpatient colonoscopy
  • Patient with history of colorectal cancer , FAP or IBD

Treatment and study plan

Break

Other

A break of 15 minute will be provided after 3rd colonoscopy in a session of 6 colonoscopies in total

No break

Other

No break will be provided

Primary outcomes

  1. Adenoma detection rate

    Time frame: 2 years

Secondary outcomes

  1. Colonoscopy insertion time

    Time frame: 2 years

  2. Cecal intubation rate

    Time frame: 2 years

  3. Patient satisfaction score

    Time frame: 2 years

    A questionnaire will be used to asses patient's satisfaction level

  4. Complication rate

    Time frame: 2 years

  5. Withdrawal time

    Time frame: 2 years

  6. Patient pain score

    Time frame: 2 years

    A questionnaire will be used to asses patient's level of pain

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Nov 21, 2013
Registry last updated
Feb 16, 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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