Trial Outcomes & Findings for Colonoscope Passive Bending Function (NCT NCT00518349)

NCT ID: NCT00518349

Last Updated: 2018-05-29

Results Overview

The proportion of patients reporting "no pain" when examined with prototype or standard colonoscope, respectively. Pain experienced was assessed by the patient in a questionnaire to be filled in at home on the day after the examination and mailed in a pre-paid envelope to a national quality register (Gastronet).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 120 participants
• Primary outcome timeframe: Pain experienced during colonoscopy
• Results posted on: 2018-05-29

Participant Flow

120 patients, routinely referred for outpatients colonosciopy, were randomized 1:1 to examination with protototype or standard colonoscope.

Exclusion criteria were pregnancy, age younger than 18 years, previous resection for colorectal disease and inability to comprehend the information given.

Participant milestones

Measure	Prototype Colonoscope Colonoscopy using prototype colonoscope	Standard Colonoscope Colonoscopy using standard colonoscope without a passive bending function
Overall Study STARTED	60	60
Overall Study COMPLETED	60	60
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Colonoscope Passive Bending Function

Baseline characteristics by cohort

Measure	1 Prototype Colonoscope n=60 Participants Colonoscopy using prototype colonoscope	2 Standard Colonoscope n=60 Participants Colonoscopy using standard colonoscope without a passive bending function	Total n=120 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	38 Participants n=93 Participants	35 Participants n=4 Participants	73 Participants n=27 Participants
Age, Categorical >=65 years	22 Participants n=93 Participants	25 Participants n=4 Participants	47 Participants n=27 Participants
Age, Continuous	58.9 years STANDARD_DEVIATION 15.4 • n=93 Participants	58.6 years STANDARD_DEVIATION 17.6 • n=4 Participants	58.8 years STANDARD_DEVIATION 16.5 • n=27 Participants
Sex: Female, Male Female	29 Participants n=93 Participants	30 Participants n=4 Participants	59 Participants n=27 Participants
Sex: Female, Male Male	31 Participants n=93 Participants	30 Participants n=4 Participants	61 Participants n=27 Participants
Region of Enrollment Norway	60 participants n=93 Participants	60 participants n=4 Participants	120 participants n=27 Participants

PRIMARY outcome

Timeframe: Pain experienced during colonoscopy

Population: Power estimates based on assumption of 20% difference in pain-free examination comparing groups

The proportion of patients reporting "no pain" when examined with prototype or standard colonoscope, respectively. Pain experienced was assessed by the patient in a questionnaire to be filled in at home on the day after the examination and mailed in a pre-paid envelope to a national quality register (Gastronet).

Outcome measures

Measure	1 Prototype Colonoscope n=60 Participants Colonoscopy using prototype colonoscope	2 Standard Colonoscope n=60 Participants Colonoscopy using standard colonoscope without a passive bending function
Patient Assessment of Pain Experienced During Colonoscopy	19 participants	10 participants

Adverse Events

Prototype Colonoscope

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Colonoscope

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. Geir Hoff

NorwegianDohsa

Phone: +4791866762

Email: hofg@online.no

Results disclosure agreements

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