Colonoscopy
Conditions
Keywords
colonoscopy, water immersion, CO2 insufflation, patients referred for diagnostic outpatient colonoscopy, (screening, surveillance, symptoms), patient discomfort associated with diagnostic colonoscopy
Brief summary
Water immersion insertion and carbon dioxide (CO2)instead of room air insufflation as alternative colonoscopy techniques have been documented to decrease patient discomfort during and after the procedure. This prospective, randomized, single-center trial was designed to evaluate whether the combination of water immersion during insertion and CO2 insufflation during withdrawal (Water/CO2)for minimal sedation colonoscopy (2 mg of midazolam i.v.)is superior to the other colonoscopy methods (Water/Air, CO2/CO2, Air/Air).
Interventions
PROCEDUREWater immersion insertion AND CO2 insufflation
* room temperature water infused by water pump into the colon just to facilitate scope insertion * CO2 insufflation by CO2 insufflation system during colonoscope withdrawal and mucosal inspection
PROCEDUREWater immersion insertion
* room temperature water infused by water pump into the colon just to facilitate scope insertion * standard room air insufflation during colonoscope withdrawal and mucosal inspection
PROCEDURECO2 insufflation
\- CO2 insufflation by CO2 insufflation system during both colonoscope insertion and 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
* men and women older than 18 years referred for diagnostic outpatient colonoscopy * provided written consent
Exclusion criteria
* history of colorectal surgery * known diagnosis of inflammatory bowel disease * chronic benzodiazepine use * refusal of minimal sedation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success Rate of Minimal Sedation Colonoscopy | six months | Successful minimal sedation colonoscopy using assigned technique was defined as reaching the caecum without switch to another insertion method and / or without additional sedation beyond the initial administration of 2 mg of midazolam. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Comfort During the Procedure and During First 24 Hours After Procedure | six months | Comfort was assessed using a 18-point questionnaire form based on 0-6 continuous scale (0 = best, 6 = worst)- abdominal pain during, 30 minutes, 3, 12 and 24 hours after the procedure, bloating duringm 30 minutes, 3, 12 and 24 hours after the procedure, flatus during, 30 minutes, 3, 12 and 24 hours after the procedure, impact on patient´s daily activities during first 24 hours after the procedure, willingnes to repeat the colonoscopy and overall satisfaction with the procedure |
Countries
Czechia
Participant flow
Recruitment details
* recruitment process between January and June 2011 * outpatients referred to our endoscopy unit for diagnostic colonoscopy
Pre-assignment details
* a total of 548 patients were assessed for eligibility * a total of 420 patients were randomized after exclusion of 128 subjects because of not fulfilled inclusion criteria * a total of 404 patients were analyzed after exclusion of 16 subjects (poor bowel preparation, IBD, argon plasmacoagulation, endoscopic resection or malignant obstruction)
Participants by arm
| Arm | Count |
|---|---|
| Water/Air Water immersion during colonoscope insertion and air insufflation during colonoscope withdrawal | 106 |
| CO2/CO2 CO2 insufflation during both colonoscope insertion and withdrawal | 105 |
| Water/CO2 water immersion during colonoscope insertion and CO2 insufflation during colonoscope withdrawal | 102 |
| Air/Air room air insufflation during both colonoscope insertion and withdrawal | 107 |
| Total | 420 |
Baseline characteristics
| Characteristic | CO2/CO2 | Water/CO2 | Water/Air | Air/Air | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 45 Participants | 48 Participants | 51 Participants | 49 Participants | 193 Participants |
| Age, Categorical Between 18 and 65 years | 60 Participants | 54 Participants | 55 Participants | 58 Participants | 227 Participants |
| Age Continuous | 59.4 years STANDARD_DEVIATION 14.5 | 58.2 years STANDARD_DEVIATION 13.4 | 60.1 years STANDARD_DEVIATION 13.9 | 58.7 years STANDARD_DEVIATION 13.8 | 59.2 years STANDARD_DEVIATION 14.1 |
| Region of Enrollment Czech Republic | 105 participants | 102 participants | 106 participants | 107 participants | 420 participants |
| Sex: Female, Male Female | 52 Participants | 49 Participants | 50 Participants | 51 Participants | 202 Participants |
| Sex: Female, Male Male | 53 Participants | 53 Participants | 56 Participants | 56 Participants | 218 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Success Rate of Minimal Sedation Colonoscopy
Successful minimal sedation colonoscopy using assigned technique was defined as reaching the caecum without switch to another insertion method and / or without additional sedation beyond the initial administration of 2 mg of midazolam.
Time frame: six months
Primary
Success Rate of Minimal Sedation Colonoscopy
A succesful colonoscopy using assigned technique was defined as reaching the caecum without switching to another insertion method and without additional sedation beyond the initial 2 mg of midazolam. Any time the further insertion of the scope was not possible, the patient reported pain level \> 3 using a 7-point Likert scale \[7\] (0 = no pain, 6 = intolerable pain) or demanded additional sedation, the endoscopist preferentially switched to the other insertion technique. Enhanced sedation was used in case the other technique had not been successful.
Time frame: 6 months
Population: Statistical power was calculated for the primary endpoint. A sample size of 145 subjects per insertion arm was calculated using two-tailed α = 0,05, β = 0,05, assuming that 80% versus 60% success rate in the water (Water/CO2 and Water/Air) and gas (CO2/CO2 and Air/Air) insertion arms would have been clinically relevant.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CO2/CO2 | Success Rate of Minimal Sedation Colonoscopy | 82.4 percentage of all participants |
| Water/Air | Success Rate of Minimal Sedation Colonoscopy | 97 percentage of all participants |
| Water/CO2 | Success Rate of Minimal Sedation Colonoscopy | 97 percentage of all participants |
| Air/Air | Success Rate of Minimal Sedation Colonoscopy | 84.2 percentage of all participants |
Secondary
Patient Comfort During the Procedure and During First 24 Hours After Procedure
Comfort was assessed using a 18-point questionnaire form based on 0-6 continuous scale (0 = best, 6 = worst)- abdominal pain during, 30 minutes, 3, 12 and 24 hours after the procedure, bloating duringm 30 minutes, 3, 12 and 24 hours after the procedure, flatus during, 30 minutes, 3, 12 and 24 hours after the procedure, impact on patient´s daily activities during first 24 hours after the procedure, willingnes to repeat the colonoscopy and overall satisfaction with the procedure
Time frame: six months