Adenoma, Carcinoma, Colitis, Functional Colonic Disease
Conditions
Brief summary
A prototype colonoscope with an extra passively bending distal section has been developed by Olympus Japan (ref. publications). The present study (2006-2007) is testing refinements of this function.
Detailed description
Results from the first prototype evaluation has been published.Modifications are presently evaluated.
Interventions
DEVICEPassive bending function
Colonoscope with a passive bending function
DEVICENo passive bending function
Examination using standard colonoscope without passive bending function
Sponsors
Sykehuset Telemark
Norwegian Department of Health and Social Affairs
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients referred for routine outpatients colonoscopy
Exclusion criteria
* Pregnant women * Age below 18 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Assessment of Pain Experienced During Colonoscopy | Pain experienced during colonoscopy | 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). |
Countries
Norway
Participant flow
Recruitment details
120 patients, routinely referred for outpatients colonosciopy, were randomized 1:1 to examination with protototype or standard colonoscope.
Pre-assignment details
Exclusion criteria were pregnancy, age younger than 18 years, previous resection for colorectal disease and inability to comprehend the information given.
Participants by arm
| Arm | Count |
|---|---|
| 1 Prototype Colonoscope Colonoscopy using prototype colonoscope | 60 |
| 2 Standard Colonoscope Colonoscopy using standard colonoscope without a passive bending function | 60 |
| Total | 120 |
Baseline characteristics
| Characteristic | 2 Standard Colonoscope | 1 Prototype Colonoscope | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 25 Participants | 22 Participants | 47 Participants |
| Age, Categorical Between 18 and 65 years | 35 Participants | 38 Participants | 73 Participants |
| Age, Continuous | 58.6 years STANDARD_DEVIATION 17.6 | 58.9 years STANDARD_DEVIATION 15.4 | 58.8 years STANDARD_DEVIATION 16.5 |
| Region of Enrollment Norway | 60 participants | 60 participants | 120 participants |
| Sex: Female, Male Female | 30 Participants | 29 Participants | 59 Participants |
| Sex: Female, Male Male | 30 Participants | 31 Participants | 61 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 60 | 0 / 60 |
| other Total, other adverse events | 0 / 60 | 0 / 60 |
| serious Total, serious adverse events | 0 / 60 | 0 / 60 |
Outcome results
Primary
Patient Assessment of Pain Experienced During Colonoscopy
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).
Time frame: Pain experienced during colonoscopy
Population: Power estimates based on assumption of 20% difference in pain-free examination comparing groups
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 1 Prototype Colonoscope | Patient Assessment of Pain Experienced During Colonoscopy | 19 participants |
| 2 Standard Colonoscope | Patient Assessment of Pain Experienced During Colonoscopy | 10 participants |