Clinical trial NCT01989650: The Effect of Taking Break During Colonoscopy Session on Adenoma Detection, a Prospective, Randomized Control Study
Official title: The Effect of Taking Break During Colonoscopy Session on Adenoma Detection, a Prospective, Randomized Control Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colonic Adenoma
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2013-11-21
Enrollment: 1379
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief 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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Adenoma detection rate
timeFrame: 2 years
Secondary outcomes:
measure: Colonoscopy insertion time
timeFrame: 2 years
measure: Cecal intubation rate
timeFrame: 2 years
measure: Patient satisfaction score
timeFrame: 2 years
measure: Complication rate
timeFrame: 2 years
measure: Withdrawal time
timeFrame: 2 years
measure: Patient pain score
timeFrame: 2 years
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Alice Ho Miu Ling Nethersole Hospital
Study officials:
References: