Trial Outcomes & Findings for Improving Bowel Preparation for Colonoscopy With a Simple Educational Card (NCT NCT00643682)

NCT ID: NCT00643682

Last Updated: 2012-10-01

Results Overview

An ordinal scale. 0=fully unprepared colon and 9=perfectly clean colon. Higher values represent a better outcome. For reference please see: Lai EJ, Calderwood AH, Doros G, Fix OK, Jacobson BC. The Boston bowel preparation scale: a valid and reliable instrument for colonoscopy-oriented research. Gastrointestinal Endoscopy 2009;69:620-625. PMCID: PMC2763922

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 2000 participants
• Primary outcome timeframe: 2 years
• Results posted on: 2012-10-01

Participant Flow

Participant milestones

Measure	Educational Card Patients in this arm will be given an educational card in addition to the standard pre-endoscopy instructions.	Control Patients in this arm will be given the standard pre-endoscopy instructions.
Overall Study STARTED	999	1001
Overall Study COMPLETED	477	492
Overall Study NOT COMPLETED	522	509

Reasons for withdrawal

Measure	Educational Card Patients in this arm will be given an educational card in addition to the standard pre-endoscopy instructions.	Control Patients in this arm will be given the standard pre-endoscopy instructions.
Overall Study did not keep appointment	522	509

Baseline Characteristics

Improving Bowel Preparation for Colonoscopy With a Simple Educational Card

Baseline characteristics by cohort

Measure	Educational Card n=477 Participants Patients in this arm will be given an educational card in addition to the standard pre-endoscopy instructions.	Control n=492 Participants Patients in this arm will be given the standard pre-endoscopy instructions.	Total n=969 Participants Total of all reporting groups
Age Continuous	57 years STANDARD_DEVIATION 8 • n=5 Participants	57 years STANDARD_DEVIATION 7 • n=7 Participants	57 years STANDARD_DEVIATION 8 • n=5 Participants
Sex: Female, Male Female	279 Participants n=5 Participants	287 Participants n=7 Participants	566 Participants n=5 Participants
Sex: Female, Male Male	198 Participants n=5 Participants	205 Participants n=7 Participants	403 Participants n=5 Participants
Region of Enrollment United States	477 participants n=5 Participants	492 participants n=7 Participants	969 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years

An ordinal scale. 0=fully unprepared colon and 9=perfectly clean colon. Higher values represent a better outcome. For reference please see: Lai EJ, Calderwood AH, Doros G, Fix OK, Jacobson BC. The Boston bowel preparation scale: a valid and reliable instrument for colonoscopy-oriented research. Gastrointestinal Endoscopy 2009;69:620-625. PMCID: PMC2763922

Outcome measures

Measure	Educational Card n=477 Participants Patients in this arm will be given an educational card in addition to the standard pre-endoscopy instructions.	Control n=492 Participants Patients in this arm will be given the standard pre-endoscopy instructions.
Boston Bowel Preparation Scale Score	6 units on a scale Interval 6.0 to 7.0	6 units on a scale Interval 6.0 to 7.0

SECONDARY outcome

Timeframe: 2 years

time in minutes to advance colonoscope from anus to tip of cecum during insertion phase of colonoscopy.

Outcome measures

Measure	Educational Card n=477 Participants Patients in this arm will be given an educational card in addition to the standard pre-endoscopy instructions.	Control n=492 Participants Patients in this arm will be given the standard pre-endoscopy instructions.
Time to Advance Colonoscope From Anus to Tip of Cecum.	7 time in minutes Interval 5.0 to 10.0	7 time in minutes Interval 5.0 to 10.0

SECONDARY outcome

Timeframe: 2 years

Time in minutes to withdraw colonoscope from tip of cecum to anus during withdrawal phase of colonoscopy

Outcome measures

Measure	Educational Card n=477 Participants Patients in this arm will be given an educational card in addition to the standard pre-endoscopy instructions.	Control n=492 Participants Patients in this arm will be given the standard pre-endoscopy instructions.
Time to Withdraw Colonoscope From Tip of Cecum to Anus.	8 Time in minutes Interval 6.0 to 11.0	7 Time in minutes Interval 6.0 to 10.0

SECONDARY outcome

Timeframe: 2 years

The number of times a colonoscopist recommended that the bowel was too unclean to qualify as an acceptable colonoscopy and therefore recommended repeating the procedure after better cleansing. This is both the number of participants with an inadequate preparation and the number of inadequate procedures. These are synonymous.

Outcome measures

Measure	Educational Card n=477 Participants Patients in this arm will be given an educational card in addition to the standard pre-endoscopy instructions.	Control n=492 Participants Patients in this arm will be given the standard pre-endoscopy instructions.
Number of Repeat Procedures Recommended Due to Inadequate Bowel Preparation.	51 participants who had a colonoscopy	49 participants who had a colonoscopy

Adverse Events

Educational Card

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Brian Jacobson, MD, Principal Investigator

Boston Medical Center

Phone: 6176386563

Email: brian.jacobson@bmc.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place