Colorectal Cancer
Conditions
Keywords
colonoscopy, warm water immersion, cool water immersion
Brief summary
Water immersion insertion has been documented to decrease procedure-related discomfort during colonoscopy. There was used warm water infusion for colonoscope insertion in most of the water immersion colonoscopy trials. The investigators have been using room temperature water (20-24°C) for water immersion and the investigators did not notice any drawback of it. In our opinion, it is simpler and cheaper option for water immersion colonoscopy and proof of its efficacy and safety could support the use of water immersion technique in routine practice. The primary endpoint is cecal intubation time and the investigators suppose that the use of warm water infusion does not 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 will be also assessed.
Interventions
PROCEDUREWarm Water Immersion Colonoscopy
Colonoscopy using warm water (37°C) infusion for colonoscope insertion and room air insufflation during colonoscope withdrawal.
PROCEDURECool Water Immersion Colonoscopy
Colonoscopy using room temperature water (20-24°C) infusion for colonoscope insertion and room air insufflation during colonoscope withdrawal.
Sponsors
Vitkovice Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Investigator)
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 |
|---|---|
| Cecal Intubation Time | 3 months |
Secondary
| Measure | Time frame |
|---|---|
| Patient Comfort During Insertion Phase of the Colonoscopy | 3 months |
Countries
Czechia
Participant flow
Recruitment details
Patients older than 18 years referred to our unit for diagnostic outpatient colonoscopy. Subjects were excluded if they has a history of colorectal surgery, known diagnosis of IBD, chronic benzodiazepine use and if they refused sedation. The period between June and October 2012.
Pre-assignment details
Subjects were not included if they did not fulfill inclusion criteria.
Participants by arm
| Arm | Count |
|---|---|
| Warm Water Immersion Colonoscopy Colonoscopy using purely warm water (37°C) infusion during colonoscope insertion and room air insufflation during colonoscope withdrawal. | 106 |
| Cool Water Immersion Colonoscopy Colonoscopy using purely room temperature water (20-24°C) infusion during colonoscope insertion and room air insufflation during colonoscope withdrawal. | 106 |
| Total | 212 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 6 | 5 |
Baseline characteristics
| Characteristic | Cool Water Immersion Colonoscopy | Warm Water Immersion Colonoscopy | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 63 Participants | 59 Participants | 122 Participants |
| Age, Categorical Between 18 and 65 years | 43 Participants | 47 Participants | 90 Participants |
| Age Continuous | 57.8 years STANDARD_DEVIATION 14.2 | 61.2 years STANDARD_DEVIATION 12.7 | 59.5 years STANDARD_DEVIATION 13.4 |
| Region of Enrollment Czech Republic | 106 participants | 106 participants | 212 participants |
| Sex: Female, Male Female | 49 Participants | 48 Participants | 97 Participants |
| Sex: Female, Male Male | 57 Participants | 58 Participants | 115 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 106 | 0 / 106 |
| serious Total, serious adverse events | 0 / 106 | 0 / 106 |
Outcome results
Primary
Cecal Intubation Time
Time frame: 3 months
Primary
Cecal Intubation Time
= time between introduction of the colonoscope into the anus and reaching the cecum.
Time frame: 1-30
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Warm Water Immersion Colonoscopy | Cecal Intubation Time | 7.0 minute | Standard Deviation 3.4 |
| Cool Water Immersion Colonoscopy | Cecal Intubation Time | 6.9 minute | Standard Deviation 3.5 |
p-value: 0.89Fisher Exact
Secondary
Patient Comfort During Insertion Phase of the Colonoscopy
Time frame: 3 months