Colonoscopy
Conditions
Keywords
sedation, warm water
Brief summary
Unsedated colonoscopy is characterized by lower costs, recovery time and incidence of drug-related side effects, although it may be painful for the patient. Based on recent reports, the investigators designed this randomized controlled trial hypothesizing that the use of water irrigation versus air insufflation during the insertion phase of colonoscopy might increase the global tolerability of the examination and the proportion of patients undergoing complete colonoscopy without sedation.
Interventions
PROCEDUREwarm water irrigation
warm water irrigation during insertion phase of colonoscopy
PROCEDUREair insufflation
air insufflation during the insertion phase of colonoscopy
Sponsors
Valduce Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* adult outpatients willing to undergo colonoscopy without routine initial sedation
Exclusion criteria
* refuse to initiate colonoscopy without routine sedation * inadequate bowel preparation * incapacity to give informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Patients Undergoing Complete Unsedated Colonoscopy | 6-9 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of Pain and Tolerability Scores | 6-9 months | Entity of pain and tolerability level on a visual analogic scale (ranging from 0 - no pain, optimal tolerability - to 100 mm - worst pain ever, unbearable) |
Countries
Italy
Participant flow
Recruitment details
medical clinic since march 2009 until sample size was reached
Pre-assignment details
no patient excluded from the study flow after being allocated in the study or control arm
Participants by arm
| Arm | Count |
|---|---|
| Warm Water warm water irrigation during the insertion phase of colonoscopy | 116 |
| Air Insufflation air insufflation during the insertion phase of colonoscopy | 114 |
| Total | 230 |
Baseline characteristics
| Characteristic | Air Insufflation | Warm Water | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 1 Participants | 2 Participants | 3 Participants |
| Age, Categorical >=65 years | 4 Participants | 6 Participants | 10 Participants |
| Age, Categorical Between 18 and 65 years | 109 Participants | 108 Participants | 217 Participants |
| Age Continuous | 58.8 years STANDARD_DEVIATION 13.3 | 58.4 years STANDARD_DEVIATION 11.5 | 58.4 years STANDARD_DEVIATION 12.1 |
| Region of Enrollment Italy | 114 participants | 116 participants | 230 participants |
| Sex: Female, Male Female | 48 Participants | 48 Participants | 96 Participants |
| Sex: Female, Male Male | 66 Participants | 68 Participants | 134 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 116 | 0 / 114 |
| serious Total, serious adverse events | 0 / 116 | 0 / 114 |
Outcome results
Primary
Number of Patients Undergoing Complete Unsedated Colonoscopy
Time frame: 6-9 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Warm Water | Number of Patients Undergoing Complete Unsedated Colonoscopy | 101 participants |
| Air Insufflation | Number of Patients Undergoing Complete Unsedated Colonoscopy | 89 participants |
Secondary
Evaluation of Pain and Tolerability Scores
Entity of pain and tolerability level on a visual analogic scale (ranging from 0 - no pain, optimal tolerability - to 100 mm - worst pain ever, unbearable)
Time frame: 6-9 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Warm Water | Evaluation of Pain and Tolerability Scores | 28 Scores on a VAS scale |
| Air Insufflation | Evaluation of Pain and Tolerability Scores | 39 Scores on a VAS scale |