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

Colonic Adenoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01989650
• Other study ID #: Break
• Status: Completed
• Phase: N/A
• First received: November 7, 2013
• Last updated: February 12, 2015
• Start date: February 2012
• Est. completion date: September 2013

Study information

• Verified date: February 2015
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1379
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Adenoma
• Colonic Adenoma

Intervention

Other:
• Break
A break of 15 minute will be provided after 3rd colonoscopy in a session of 6 colonoscopies in total
• No break
No break will be provided

Locations

Country	Name	City	State
Hong Kong	Alice Ho Miu Ling Nethersole Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adenoma detection rate		2 years	No
Secondary	Colonoscopy insertion time		2 years	No
Secondary	Cecal intubation rate		2 years	No
Secondary	Patient satisfaction score	A questionnaire will be used to asses patient's satisfaction level	2 years	No
Secondary	Complication rate		2 years	No
Secondary	Withdrawal time		2 years	No
Secondary	Patient pain score	A questionnaire will be used to asses patient's level of pain	2 years	No