Colonic Adenoma, Water Exchange Colonoscopy
Conditions
Keywords
Adenoma miss rate, Adenoma detection rate
Brief summary
This was an observational study comparing consecutive group of WE and CO2 insufflation in terms of right and proximal colon AMR by tandem colonoscopy.
Detailed description
This was a prospective observational study to assess how WE colonoscopy would fit into clinical and research practices. We first observed whether optimal WE colonoscopy decreased the AMR in the right and proximal colon in a tandem approach. If WE did lower the AMR as compared with data in the literature, a randomized RCT deserves to be studied. For the calculation of sample size in the upcoming RCT, the AMR in the CO2 group would be collected. The differences of the AMRs in the right and proximal colon determined by tandem colonoscopy using WE or CO2 insufflation would then be compared.
Interventions
PROCEDUREWater exchange colonoscopy
During back-to-back colonoscopy, the first examination was completed with water exchange during insertion and CO2 insufflation during withdrawal. The second examination was completed with CO2 insufflation during both the insertion and withdrawal.
PROCEDURECO2 insufflation colonoscopy
During back-to-back colonoscopy, the first examination was completed with CO2 insufflation during both the insertion and withdrawal. The second examination was also completed with CO2 insufflation during both the insertion and withdrawal.
Sponsors
Evergreen General Hospital, Taiwan
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Consecutive patients aged 20 years or older undergoing colonoscopy for screening and surveillance indications were considered for enrollment.
Exclusion criteria
* familial adenomatous polyposis and hereditary non-polyposis CRC syndrome, personal history of inflammatory bowel disease, previous colonic resection, inability to achieve cecal intubation, obstructive lesions of the colon, poor colon preparation, inability to completely remove a polyp, gastrointestinal bleeding, allergy to fentanyl or midazolam, American Society of Anesthesiology classification of physical status grade 3 or higher, mental retardation, pregnancy, and refusal to provide a written informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Overall Detected Adenomas Missed During the First Right-Colon Colonoscopy | During procedure, approximately 1.5 hours | Right-colon (cecum, A-colon, hepatic flexure) adenomas detected on the second-pass examination were used for the calculation of adenoma miss. Adenoma miss rate was calculated as the number of adenomas missed in the first colonoscopy divided by the total number of adenomas detected during both the first and second colonoscopies. |
| Percentage of Overall Detected Adenomas Missed During the First Proximal-Colon Colonoscopy | During procedure, approximately 1.5 hours | Proximal-colon (cecum, A-colon, hepatic flexure, T-colon) adenomas detected on the second-pass examination were used for the calculation of adenoma miss. Adenoma miss rate was calculated as the number of adenomas missed in the first colonoscopy divided by the total number of adenomas detected during both the first and second colonoscopies. |
Countries
Taiwan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Water Exchange Colonoscopy During the insertion phase of the first-pass colonoscopy, WE method was used. When the cecum was reached, CO2 was opened during the withdrawal phase of the first-pass colonoscopy. After the first complete withdrawal of the colonoscope, a second colonoscopic examination aided by CO2 insufflation during insertion and withdrawal was performed by the same endoscopist. The colonoscope was reinserted into the cecum as quickly as possible, and the entire colon was re-examined. Polyp resection was carried out during insertion and withdrawal of the first- and second-pass examinations. | 86 |
| CO2 Insufflation Colonoscopy During the first-pass colonoscopy, the procedure was performed in the usual fashion, with minimal CO2 insufflation to aid insertion. Cleaning of colon was predominantly performed during withdrawal. After the first complete withdrawal of the colonoscope, a second colonoscopic examination aided by CO2 insufflation during insertion and withdrawal was performed by the same endoscopist. The colonoscope was reinserted into the cecum as quickly as possible, and the entire colon was re-examined. Polyp resection was carried out during insertion and withdrawal of the first- and second-pass examinations. | 86 |
| Total | 172 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Failed cecal intubation in 2nd exam | 3 | 1 |
Baseline characteristics
| Characteristic | Water Exchange Colonoscopy | CO2 Insufflation Colonoscopy | Total |
|---|---|---|---|
| Age, Continuous | 53.4 years STANDARD_DEVIATION 10.7 | 52.9 years STANDARD_DEVIATION 9.6 | 53.1 years STANDARD_DEVIATION 10.1 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Taiwan | 86 participants | 86 participants | 172 participants |
| Sex: Female, Male Female | 43 Participants | 39 Participants | 82 Participants |
| Sex: Female, Male Male | 43 Participants | 47 Participants | 90 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 86 | 0 / 86 |
| other Total, other adverse events | 0 / 86 | 0 / 86 |
| serious Total, serious adverse events | 0 / 86 | 0 / 86 |
Outcome results
Primary
Percentage of Overall Detected Adenomas Missed During the First Proximal-Colon Colonoscopy
Proximal-colon (cecum, A-colon, hepatic flexure, T-colon) adenomas detected on the second-pass examination were used for the calculation of adenoma miss. Adenoma miss rate was calculated as the number of adenomas missed in the first colonoscopy divided by the total number of adenomas detected during both the first and second colonoscopies.
Time frame: During procedure, approximately 1.5 hours
| Arm | Measure | Value (MEAN) |
|---|---|---|
| CO2 Insufflation Colonoscopy | Percentage of Overall Detected Adenomas Missed During the First Proximal-Colon Colonoscopy | 15.5 percentage of detected adenomas |
| Water Exchange Colonoscopy | Percentage of Overall Detected Adenomas Missed During the First Proximal-Colon Colonoscopy | 30.4 percentage of detected adenomas |
Primary
Percentage of Overall Detected Adenomas Missed During the First Right-Colon Colonoscopy
Right-colon (cecum, A-colon, hepatic flexure) adenomas detected on the second-pass examination were used for the calculation of adenoma miss. Adenoma miss rate was calculated as the number of adenomas missed in the first colonoscopy divided by the total number of adenomas detected during both the first and second colonoscopies.
Time frame: During procedure, approximately 1.5 hours
| Arm | Measure | Value (MEAN) |
|---|---|---|
| CO2 Insufflation Colonoscopy | Percentage of Overall Detected Adenomas Missed During the First Right-Colon Colonoscopy | 33.8 percentage of detected adenomas |
| Water Exchange Colonoscopy | Percentage of Overall Detected Adenomas Missed During the First Right-Colon Colonoscopy | 17.5 percentage of detected adenomas |