Trial Outcomes & Findings for Efficacy of Morning-only Bowel Preparation for Afternoon Colonoscopy. (NCT NCT00687830)

NCT ID: NCT00687830

Last Updated: 2017-05-17

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 136 participants
• Primary outcome timeframe: Within 1 hr after the colonoscopy procedure
• Results posted on: 2017-05-17

Participant Flow

Participant milestones

Measure	Evening Bowel prep given in the evening prior to the day of the afternoon colonoscopy	Morning Bowel prep given on the morning of the day of the afternoon colonoscopy
Overall Study STARTED	68	68
Overall Study COMPLETED	68	68
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy of Morning-only Bowel Preparation for Afternoon Colonoscopy.

Baseline characteristics by cohort

Measure	Evening n=68 Participants Bowel prep given in the evening prior to the day of the afternoon colonoscopy	Morning n=68 Participants Bowel prep given on the morning of the day of the afternoon colonoscopy	Total n=136 Participants Total of all reporting groups
Age, Continuous	52.2 years STANDARD_DEVIATION 11.5 • n=5 Participants	51.4 years STANDARD_DEVIATION 10.2 • n=7 Participants	51.8 years STANDARD_DEVIATION 10.8 • n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants	35 Participants n=7 Participants	65 Participants n=5 Participants
Sex: Female, Male Male	38 Participants n=5 Participants	33 Participants n=7 Participants	71 Participants n=5 Participants

PRIMARY outcome

Timeframe: Within 1 hr after the colonoscopy procedure

Outcome measures

Measure	Evening n=68 Participants Bowel prep given in the evening prior to the day of the afternoon colonoscopy	Morning n=68 Participants Bowel prep given on the morning of the day of the afternoon colonoscopy
Comparing All Morning Bowel Prep to Evening Bowel Prep for Patients Undergoing Afternoon Colonoscopies. (Using Ottawa Scale Scores, Range 0-14) Lower Score Indicates a Better Outcome.	7.1 units on a scale Standard Deviation 2.7	4.7 units on a scale Standard Deviation 2.4

SECONDARY outcome

Timeframe: An hour before the colonoscopy procedure

Variable used to assess patient satisfaction: Loss of sleep. The numbers below depict the number of participants who experienced loss of sleep.

Outcome measures

Measure	Evening n=68 Participants Bowel prep given in the evening prior to the day of the afternoon colonoscopy	Morning n=68 Participants Bowel prep given on the morning of the day of the afternoon colonoscopy
Patient Satisfaction in the Two Groups, All Morning Prep vs. All Evening Bowel Prep.	21 participants	11 participants

Adverse Events

Evening

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Morning

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

Dr. Shibu Varughese and Dr. Anand Kumar

Cleveland Clinic Florida

Phone: 305-310-1238

Email: akuma003@fiu.edu

Results disclosure agreements

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