Colonoscopy
Conditions
Keywords
colonoscopy, cap-assisted colonoscopy, water immersion colonoscopy
Brief summary
Water immersion insertion has been documented to decrease procedure-related discomfort during colonoscopy. Cap attached to the colonoscope tip may improve insertion and shorten cecal intubation time. The investigators would like to assess whether combination of cap-fitted colonoscopy and water immersion insertion is feasible and safe method of diagnostic colonoscopy. The primary endpoint is cecal intubation time and the investigators suppose that the use of cap is able to shorten it significantly. Patient comfort during colonoscope insertion, water consumption, length of the scope while reaching the cecum, need for external compression, need for positioning of the patient and endoscopist´s difficulty with colonoscopy are assessed.
Interventions
DEVICEsoft straight distal cap D-201-14304 Olympus attached to the tip of the colonoscope
Colonoscopy with transparent cap attached to the tip of the colonoscope and water immersion during insertion phase and romm air insufflation during colonoscope withdrawal.
PROCEDUREwater immersion colonoscopy
Colonoscopy without transparent cap using water immersion during insertion phase and romm air insufflation during colonoscope withdrawal.
Sponsors
Vitkovice Hospital
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
* outpatient diagnostic colonoscopy * bowel prep with macrogolum * initial 2 mg of midazolam i.v. * signed informed consent form
Exclusion criteria
* planned therapeutic intervention * colorectal surgery in history * known inflammatory bowel disease or colorectal cancer * refusal of sedation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cecal Intubation Time | 3 months | The primary endpoint (cecal intubation time) was defined as a time between introduction of the colonoscope into the anus and reaching the cecum. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Comfort During Insertion Phase of the Colonoscopy | 3 months | — |
| Success Rate of Minimal Sedation Colonoscopy | 3 months | A successful minimal sedation colonoscopy was defined as reaching the cecum without switching to another insertion method and without additional sedation beyond the initial 2 mg of midazolam. |
Countries
Czechia
Participant flow
Recruitment details
* recruitment period - between March and May 2012 * consecutive patients referred to our endoscopic unit for diagnostic colonoscopy
Pre-assignment details
* a total of 275 subjects assessed for eligibility * a total of 208 patients eandomized after exclusion of 67 due to not fulfilled inclusion criteria * a total of 196 subjects analyzed after exclusion of 12 patients (poor bowel preparation, IBD, malignant obstruction, protocol deviation, ischemic colitis)
Participants by arm
| Arm | Count |
|---|---|
| Cap-assisted Water Immersion Colonoscopy Cap-fitted colonoscopy using purely water immersion during colonoscope insertion and room air insufflation during colonoscope withdrawal. | 104 |
| Water Immersion Colonoscopy Standard colonoscopy without attached cap using purely water immersion during colonoscope insertion and room air insufflation during colonoscope withdrawal. | 104 |
| Total | 208 |
Baseline characteristics
| Characteristic | Water Immersion Colonoscopy | Cap-assisted Water Immersion Colonoscopy | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 53 Participants | 55 Participants | 108 Participants |
| Age, Categorical Between 18 and 65 years | 51 Participants | 49 Participants | 100 Participants |
| Age, Continuous | 58.2 years STANDARD_DEVIATION 13.9 | 59.2 years STANDARD_DEVIATION 12 | 58.6 years STANDARD_DEVIATION 12.8 |
| Region of Enrollment Czech Republic | 104 participants | 104 participants | 208 participants |
| Sex: Female, Male Female | 45 Participants | 45 Participants | 90 Participants |
| Sex: Female, Male Male | 59 Participants | 59 Participants | 118 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Cecal Intubation Time
The primary endpoint (cecal intubation time) was defined as a time between introduction of the colonoscope into the anus and reaching the cecum.
Time frame: 3 months
Population: Statistical power was calculated for the primary endpoint. A sample size of 93 subjects per arm was calculated using two-tailed alfa 0.05, beta 0.2, assuming that difference 20 % in intubation times would have been clinically relevant.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cap-assisted Water Immersion Colonoscopy | Cecal Intubation Time | 6.9 minutes |
| Water Immersion Colonoscopy | Cecal Intubation Time | 7.4 minutes |
Secondary
Patient Comfort During Insertion Phase of the Colonoscopy
Time frame: 3 months
Secondary
Success Rate of Minimal Sedation Colonoscopy
A successful minimal sedation colonoscopy was defined as reaching the cecum without switching to another insertion method and without additional sedation beyond the initial 2 mg of midazolam.
Time frame: 3 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cap-assisted Water Immersion Colonoscopy | Success Rate of Minimal Sedation Colonoscopy | 91 percentage of all subjects in arm |
| Water Immersion Colonoscopy | Success Rate of Minimal Sedation Colonoscopy | 91 percentage of all subjects in arm |