Colonoscopy, Digestive System, Endoscopy, Gastrointestinal Disease
Conditions
Keywords
colonoscopy, diagnostic techniques, digestive system, endoscopy, gastrointestinal
Brief summary
Recent studies indicate that infusing 300 milliliters of water (in lieu of air) into the rectum and left colon through the colonoscope as it is being inserted during a colonoscopy examination can allow easier endoscope advancement. This method may prevent stretching of the colon, and ultimately reduce pain induced during colonoscopy. Improvements in patient comfort and cooperation, may increase the efficiency and success rate of complete colonoscopy. The purpose of the study is to test the efficacy of the water immersion technique in patients colonoscopy.
Interventions
PROCEDUREwater immersion colonoscopy
instillation of 300cc of water in the rectum
PROCEDUREstandard air colonoscopy
air instillation in colon for visualization
Sponsors
VA Palo Alto Health Care System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* presentation for colonoscopy * male * age 18 or older
Exclusion criteria
* women * known inflammatory bowel disease * presentation for emergency colonoscopy * history of partial colectomy * chronic narcotic or benzodiazepine use
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Colonoscopy Success With Minimal Sedation | At the time of the procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Cecum | At the time of the procedure | — |
| Patient Satisfaction | At the time of the procedure | Patient satisfaction was measured on a scale of 1 (best) to 7 (worst). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Water Immersion Colonoscopy Water immersion colonoscopy: instillation of 300cc of water in the rectum | 112 |
| Standard Air Colonoscopy Standard air colonoscopy: air instillation in colon for visualization | 114 |
| Total | 226 |
Baseline characteristics
| Characteristic | Water Immersion Colonoscopy | Standard Air Colonoscopy | Total |
|---|---|---|---|
| Age, Continuous | 62.5 years STANDARD_DEVIATION 8.9 | 62.5 years STANDARD_DEVIATION 8.9 | 62.5 years STANDARD_DEVIATION 8.9 |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 112 Participants | 114 Participants | 226 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 114 | 0 / 115 |
| serious Total, serious adverse events | 0 / 1,114 | 0 / 115 |
Outcome results
Primary
Colonoscopy Success With Minimal Sedation
Time frame: At the time of the procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Water Immersion Colonoscopy | Colonoscopy Success With Minimal Sedation | 57 Participants |
| Standard Air Colonoscopy | Colonoscopy Success With Minimal Sedation | 32 Participants |
Secondary
Patient Satisfaction
Patient satisfaction was measured on a scale of 1 (best) to 7 (worst).
Time frame: At the time of the procedure
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Water Immersion Colonoscopy | Patient Satisfaction | 1.09 units on a scale |
| Standard Air Colonoscopy | Patient Satisfaction | 1.26 units on a scale |
Secondary
Time to Cecum
Time frame: At the time of the procedure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Water Immersion Colonoscopy | Time to Cecum | Attending | 5.4 minutes | Standard Deviation 5.9 |
| Water Immersion Colonoscopy | Time to Cecum | Trainee | 13 minutes | Standard Deviation 7.5 |
| Standard Air Colonoscopy | Time to Cecum | Trainee | 20.5 minutes | Standard Deviation 13.9 |
| Standard Air Colonoscopy | Time to Cecum | Attending | 7.2 minutes | Standard Deviation 5.8 |