Colon Neoplasm, Pain
Conditions
Keywords
colonoscopy
Brief summary
In minimally sedated Asian patients in a community setting the investigators showed that a limited volume of water infusion instead of air insufflation in either the rectal sigmoid colon or the whole colon significantly reduced pain score during colonoscopy. Cecal intubation rate was not compromised. The reduction of pain score ranges from 25% to 32 % in our previous studies.1, 2 In contrast, several US reports described the successful use larger volumes of water infused throughout the entire colon in patients undergoing colonoscopy which result in a greater reduction of the pain score, averaging about 56%.3-5 A recent review suggested that the cause of the difference might lies in the timing of water removal.6 Specifically, the investigators group removed the infused water predominantly during withdrawal phase (water immersion) and the U.S. group removed water during insertion phase (water exchange). This prospective, randomized controlled trial compared water exchange or water immersion with traditional air insufflation in patients undergoing minimally sedated colonoscopy. The investigators test the hypothesis that water exchange can reduce more pain than water immersion in the investigators clinical setting.
Detailed description
All procedures will be recorded and stored as digital files.
Interventions
PROCEDUREair insufflation
insufflate air during the insertion of colonoscopy
PROCEDUREwater immersion
infuse water during insertion, aspirate water during withdrawal
PROCEDUREwater exchange
infuse and remove water during insertion phase of colonoscopy
Sponsors
Dalin Tzu Chi General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients undergoing minimally sedated colonoscopy
Exclusion criteria
* Obstructive lesions of the colon, inadequate bowel preparation, allergy to meperidine, massive ascites, past history of partial colectomy, or refusal to provide written informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients Without Pain | up to 12 months | proportion of patients without insertion pain during colonoscopy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Pain Score | 9 to 12 months | The maximal pain score during insertion phase of colonoscopy was assessed with 0 to 10 scale VAS score (0: no pain; 10: maximal pain) |
| Patient Satisfaction Score | 9 to 12 months | satisfaction score obtained after colonoscopy 0 = no satisfied; 10 = most satisfied |
| Number of Participants With at Least One Adenoma | 9 to 12 months | the number of participants with at least one adenoma in each of the study groups. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Post-procedure Discomforts and 30 Day Complication Rate | one month | telephone follow up for post-procedure discomforts and 30 day complication rate |
Countries
Taiwan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Air Insufflation Use air insufflation during colonoscopy
air insufflation: insufflate air during the insertion of colonoscopy | 90 |
| Water Immersion infuse water during insertion, remove water during withdrawal of colonoscopy
water immersion: infuse water during insertion, aspirate water during withdrawal | 90 |
| Water Exchange infuse and remove water during insertion phase of colonoscopy
water exchange: infuse and remove water during insertion phase of colonoscopy | 90 |
| Total | 270 |
Baseline characteristics
| Characteristic | Air Insufflation | Water Immersion | Water Exchange | Total |
|---|---|---|---|---|
| Age, Continuous | 59 years | 53 years | 58 years | 55 years |
| Sex: Female, Male Female | 30 Participants | 37 Participants | 35 Participants | 102 Participants |
| Sex: Female, Male Male | 60 Participants | 53 Participants | 55 Participants | 168 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 90 | 0 / 90 | 0 / 90 |
| serious Total, serious adverse events | 0 / 90 | 0 / 90 | 1 / 90 |
Outcome results
Primary
Proportion of Patients Without Pain
proportion of patients without insertion pain during colonoscopy
Time frame: up to 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Air Insufflation | Proportion of Patients Without Pain | 27 participants |
| Water Immersion | Proportion of Patients Without Pain | 39 participants |
| Water Exchange | Proportion of Patients Without Pain | 55 participants |
Secondary
Number of Participants With at Least One Adenoma
the number of participants with at least one adenoma in each of the study groups.
Time frame: 9 to 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Air Insufflation | Number of Participants With at Least One Adenoma | 39 participants |
| Water Immersion | Number of Participants With at Least One Adenoma | 41 participants |
| Water Exchange | Number of Participants With at Least One Adenoma | 51 participants |
Secondary
Patient Pain Score
The maximal pain score during insertion phase of colonoscopy was assessed with 0 to 10 scale VAS score (0: no pain; 10: maximal pain)
Time frame: 9 to 12 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Air Insufflation | Patient Pain Score | 3.5 units on a scale |
| Water Immersion | Patient Pain Score | 1.8 units on a scale |
| Water Exchange | Patient Pain Score | 0 units on a scale |
Secondary
Patient Satisfaction Score
satisfaction score obtained after colonoscopy 0 = no satisfied; 10 = most satisfied
Time frame: 9 to 12 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Air Insufflation | Patient Satisfaction Score | 10 units on a scale |
| Water Immersion | Patient Satisfaction Score | 10 units on a scale |
| Water Exchange | Patient Satisfaction Score | 10 units on a scale |
Other Pre-specified
Post-procedure Discomforts and 30 Day Complication Rate
telephone follow up for post-procedure discomforts and 30 day complication rate
Time frame: one month