Colonoscopy, Pain
Conditions
Keywords
Colonoscopy, Endoguide, Pain perception, Colonoscopy to the coecum (success rate), Patient's perception of pain, Duration of successful colonoscopies
Brief summary
The study includes 700 patients referred for colonoscopy are randomized to colonoscopy with or without endoguide. The study will investigate whether the endoguide improves success rate and the patient's perception of pain.
Interventions
DEVICEEndoguide
Use of endoguide to facilitate completion of endoscopy
Sponsors
Danish Medical Association
Surgical Clinic, Allerød, Denmark
The Specialist Doctors at Rolighedsvej
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Informed consent provided
Exclusion criteria
* Informed consent not provided or not possible to obtain
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Completed Colonoscopy | immediately after colonoscopy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perception of Pain | After endoscopy (within 10mins) and 1 day after endoscopy | VAS (Visual Analogue Scale), 0 - 10. VAS 0 is no pain, VAS 10 is max pain. Scores on a scale |
Countries
Denmark
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| With Endoguide Colonoscopy completed with endoguide | 555 |
| Without Endoguide Colonoscopy completed without endoguide | 449 |
| Total | 1,004 |
Baseline characteristics
| Characteristic | Without Endoguide | With Endoguide | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 152 Participants | 173 Participants | 325 Participants |
| Age, Categorical Between 18 and 65 years | 297 Participants | 382 Participants | 679 Participants |
| Age Continuous | 56 years STANDARD_DEVIATION 15 | 56 years STANDARD_DEVIATION 14 | 56 years STANDARD_DEVIATION 15 |
| Region of Enrollment Denmark | 449 participants | 555 participants | 1004 participants |
| Sex: Female, Male Female | 256 Participants | 308 Participants | 564 Participants |
| Sex: Female, Male Male | 193 Participants | 247 Participants | 440 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 555 | 0 / 449 |
| serious Total, serious adverse events | 0 / 555 | 0 / 449 |
Outcome results
Primary
Completed Colonoscopy
Time frame: immediately after colonoscopy
Population: Choosen by randomization.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| With Endoguide - Success Rate | Completed Colonoscopy | 555 participants |
| Without Endoguide | Completed Colonoscopy | 449 participants |
Secondary
Perception of Pain
VAS (Visual Analogue Scale), 0 - 10. VAS 0 is no pain, VAS 10 is max pain. Scores on a scale
Time frame: After endoscopy (within 10mins) and 1 day after endoscopy
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| With Endoguide - Success Rate | Perception of Pain | Score within 10mins of endoscopy | 3.84 Scores on a scale 0-10 | Standard Deviation 2.78 |
| With Endoguide - Success Rate | Perception of Pain | Score 1 day after endoscopy | 3.56 Scores on a scale 0-10 | Standard Deviation 2.9 |
| Without Endoguide | Perception of Pain | Score within 10mins of endoscopy | 4.12 Scores on a scale 0-10 | Standard Deviation 2.98 |
| Without Endoguide | Perception of Pain | Score 1 day after endoscopy | 3.72 Scores on a scale 0-10 | Standard Deviation 3.15 |