Adenoma, Colonic Neoplasms
Conditions
Brief summary
We plan to conduct a randomized trial of tandem colonoscopies comparing water infusion and air insufflation for inspection of mucosa on withdrawal. In one randomized group, water infusion will be employed as the first method for mucosal inspection while in a second group, CO2 insufflation will be used first. This study will be different than usual care since the participants will receive two successive or tandem colonoscopies versus one
Interventions
PROCEDUREWater Infusion first
In this group patients will receive a colonoscopy with water infusion for mucosal inspection and then receive a colonoscopy with CO2 insufflation.
PROCEDURECO2 Insufflation First
In this group patients will receive a colonoscopy with CO2 insufflation for mucosal inspection and then receive a colonoscopy with water infusion .
Sponsors
Indiana University
White River Junction Veterans Affairs Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SCREENING
Masking
NONE
Intervention model description
In one randomized group, water infusion will be employed as the first method for mucosal inspection while in a second group, CO2 insufflation will be used first. This study will be different than usual care since the participants will receive two successive or tandem colonoscopies versus one
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* all adults 50 years or older who present for colonoscopy at White River Junction VAMC and Indiana University
Exclusion criteria
* includes co-morbid status of ASA III or higher, Inflammatory Bowel Disease (IBD), surgical resection of the large bowel, as well as the use of anticoagulants. Finally, potential subjects who do not report a clear effluent in the most recent bowel movement will be excluded from the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adenoma Miss Rate | Through procedure, an average of 1 hr | Adenoma-level miss rates will be calculated as the number of additional adenomas detected during the second examination divided by the total number of adenomas detected during both examinations |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient-level Miss Rate | 1 hour or the duration of the procedure | Patient-level miss rates will be calculated as the number of patients with one or more adenomas detected during the second examination, divided by the total number of patients with at least one adenoma in either examination |
| Adenoma < 6mm Detection Rate | 1 hour or the duration of the procedure | Adenoma-level miss rates will be calculated as the number of additional adenomas \< 6 mm detected during the second examination divided by the total number of adenomas\< 6 mm detected during both examinations. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Water Infusion First In this group patients will receive a colonoscopy with water infusion for mucosal inspection and then receive a colonoscopy with CO2 insufflation.
Water Infusion first: In this group patients will receive a colonoscopy with water infusion for mucosal inspection and then receive a colonoscopy with CO2 insufflation. | 60 |
| CO2 Insufflation First In this group patients will receive a colonoscopy with CO2 insufflation for mucosal inspection and then receive a colonoscopy with water infusion.
CO2 Insufflation First: In this group patients will receive a colonoscopy with CO2 insufflation for mucosal inspection and then receive a colonoscopy with water infusion . | 61 |
| Total | 121 |
Baseline characteristics
| Characteristic | Water Infusion First | CO2 Insufflation First | Total |
|---|---|---|---|
| Age, Continuous | 63.4 years STANDARD_DEVIATION 7.5 | 63.4 years STANDARD_DEVIATION 8.4 | 63.4 years STANDARD_DEVIATION 7.8 |
| Colonoscopy ordered for screening purposes? | 17 Participants | 21 Participants | 38 Participants |
| Monitored anesthesia care (MAC) | 35 Participants | 35 Participants | 70 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 60 participants | 61 participants | 121 participants |
| Sex: Female, Male Female | 16 Participants | 12 Participants | 28 Participants |
| Sex: Female, Male Male | 44 Participants | 49 Participants | 93 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 60 | 0 / 61 |
| other Total, other adverse events | 0 / 60 | 0 / 61 |
| serious Total, serious adverse events | 0 / 60 | 0 / 61 |
Outcome results
Primary
Adenoma Miss Rate
Adenoma-level miss rates will be calculated as the number of additional adenomas detected during the second examination divided by the total number of adenomas detected during both examinations
Time frame: Through procedure, an average of 1 hr
Population: Adenoma miss rate
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Water Infusion First | Adenoma Miss Rate | 52 adenomas missed by first exam |
| CO2 Insufflation First | Adenoma Miss Rate | 37 adenomas missed by first exam |
Secondary
Adenoma < 6mm Detection Rate
Adenoma-level miss rates will be calculated as the number of additional adenomas \< 6 mm detected during the second examination divided by the total number of adenomas\< 6 mm detected during both examinations.
Time frame: 1 hour or the duration of the procedure
Population: Adenomas \< 6 mm
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Water Infusion First | Adenoma < 6mm Detection Rate | 45 Adenomas < 6 mm |
| CO2 Insufflation First | Adenoma < 6mm Detection Rate | 36 Adenomas < 6 mm |
p-value: 0.48Chi-squared
Secondary
Patient-level Miss Rate
Patient-level miss rates will be calculated as the number of patients with one or more adenomas detected during the second examination, divided by the total number of patients with at least one adenoma in either examination
Time frame: 1 hour or the duration of the procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Water Infusion First | Patient-level Miss Rate | 27 Participants |
| CO2 Insufflation First | Patient-level Miss Rate | 23 Participants |