NCT01989650

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,379

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 7, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 21, 2013

Completed
Last Updated

February 16, 2015

Status Verified

February 1, 2015

Enrollment Period

1.6 years

First QC Date

November 7, 2013

Last Update Submit

February 12, 2015

Conditions

Colonic Adenoma

Outcome Measures

Primary Outcomes (1)

  • Adenoma detection rate

    2 years

Secondary Outcomes (6)

  • Colonoscopy insertion time

    2 years

  • Cecal intubation rate

    2 years

  • Patient satisfaction score

    2 years

  • Complication rate

    2 years

  • Withdrawal time

    2 years

  • +1 more secondary outcomes

Study Arms (2)

Break

ACTIVE COMPARATOR

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

Other: BreakOther: No break

No break

NO INTERVENTION

No break will be provided

Interventions

BreakOTHER

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

Break
No breakOTHER

No break will be provided

Break

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alice Ho Miu Ling Nethersole Hospital

Hong Kong, Hong Kong

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

November 7, 2013

First Posted

November 21, 2013

Study Start

February 1, 2012

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

February 16, 2015

Record last verified: 2015-02

Locations

HK(1)