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This was an observational study comparing consecutive group of WE and CO2 insufflation in terms of right and proximal colon AMR by tandem colonoscopy.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Water exchange colonoscopy | During the insertion phase of the first-pass colonoscopy, water exchange (WE) method was used. WE entailed the infusion of water to open the lumen and sequentially suction of water. When the cecum was reached and after most of the water was suctioned to collapse the cecal lumen, 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. |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Water exchange colonoscopy | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | During procedure, approximately 1.5 hours |
| 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. | During procedure, approximately 1.5 hours |
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Inclusion Criteria:
Exclusion Criteria:
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86 eligible patients completed first-pass colonoscopy with WE insertion and CO2 withdrawal, followed by back-to-back second-pass colonoscopy with CO2 insertion and CO2 withdrawal during July 9 to Oct 12, 2018; Another 86 eligible patient completed first-pass colonoscopy with CO2 insertion and CO2 withdrawal, followed by back-to-back second-pass colonoscopy with CO2 insertion and CO2 withdrawal during Oct 15 to Nov 21, 2018.
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| Name | Affiliation | Role |
|---|---|---|
| Chi-Liang Cheng | Evergreen General Hospital, Taoyuan, Taiwan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Evergreen General Hospital | Taoyuan | 320 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31412789 | Derived | Cheng CL, Kuo YL, Hsieh YH, Tang JH, Leung FW. Water exchange colonoscopy decreased adenoma miss rates compared with literature data and local data with CO2 insufflation: an observational study. BMC Gastroenterol. 2019 Aug 14;19(1):143. doi: 10.1186/s12876-019-1065-2. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Water Exchange Colonoscopy | During the insertion phase of the first-pass colonoscopy, water exchange (WE) method was used. WE entailed the infusion of water to open the lumen and sequentially suction of water. When the cecum was reached and after most of the water was suctioned to collapse the cecal lumen, 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | 95% Confidence Interval | percentage of detected adenomas | During procedure, approximately 1.5 hours |
|
one month
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Water Exchange Colonoscopy | During the insertion phase of the first-pass colonoscopy, water exchange (WE) method was used. WE entailed the infusion of water to open the lumen and sequentially suction of water. When the cecum was reached and after most of the water was suctioned to collapse the cecal lumen, 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Chi-Liang Cheng | Evergreen General Hospital, Taiwan | 0919768058 | chiliang.cheng@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 3, 2019 | May 12, 2019 | Prot_SAP_002.pdf |
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|
| CO2 insufflation colonoscopy | Procedure | 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. |
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Water Exchange Colonoscopy | During the insertion phase of the first-pass colonoscopy, water exchange (WE) method was used. WE entailed the infusion of water to open the lumen and sequentially suction of water. When the cecum was reached and after most of the water was suctioned to collapse the cecal lumen, 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. |
|
|
| 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. | Posted | Mean | 95% Confidence Interval | percentage of detected adenomas | During procedure, approximately 1.5 hours |
|
|
|
| 0 |
| 86 |
| 0 |
| 86 |
| 0 |
| 86 |
| EG001 | 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. | 0 | 86 | 0 | 86 | 0 | 86 |
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