An interventional study of Colon polypectomy in Colon Polyp and Colon Adenoma, sponsored by Evergreen General Hospital, Taiwan. Completed at 1 site in Taiwan. Open to participants aged 45 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-05-09.
Sponsored by Evergreen General Hospital, Taiwan · Not applicable, Interventional, and Treatment
Small colon polyps which are found during colonoscopy insertion are sometimes difficult to find during withdrawal and thus missed. The investigators aim to evaluate the differences of colon polyp/adenoma detection rates of patients undergoing additional inspection and polypectomy during insertion as compared to the patients undergoing traditional practice of careful inspection and polypectomy performed entirely during withdrawal of colonoscopy.
Participants will be randomly assigned by a research assistant, by using a computer-generated randomization sequence to undergo colonoscopy with either inspection and polypectomy during both insertion and withdrawal of colonoscope (study group) or inspection and polypecotmy entirely during withdrawal of colonoscope (control group). Randomization will be done via concealed allocation with a sealed envelope that designate study group or control group.
Colonoscopies will be performed by two experienced investigators by using a standard colonoscopy (CF-Q260AI or CF-Q260AL; Olympus Medical Systems Corp., Tokyo, Japan). All procedures are performed under moderate conscious sedation with fentanyl (United Biomedical, Taipei, Taiwan) and midazolam (Dormicum; Roche Pharmaceuticals, Basel, Switzerland) according to the current guidelines. Carbon dioxide insufflation is used for all endoscopic procedures. All participants receive 3-L polyethylene glycol (PEG; Klean-Prep, Helsinn Birex Pharmaceuticals Ltd., Dublin, Ireland) for bowel preparation. A split-dose of the PEG preparation is provided. The level of colon cleansing is prospectively evaluated with the Boston Bowel Preparation Scale score.
For participants assigned into the study group, the colonic lumen is washed with saline and the fluid and debris are suctioned as the instrument is slowly inserted from rectum to cecum. Deliberate and systematic inspection of the colonic mucosa is performed with adequate luminal insufflations during both the insertion and withdrawal phases. Polyp size is determined by comparison with open colonoscopic biopsy forceps pushed against the polyp or, in some cases of pedunculated polyp by direct measurement after retrieval. Polyps with size \<10mm are removed as they are identified on insertion and withdrawal. Polyps with size ≥10mm are removed only during withdrawal.
For participants assigned into the control group, deliberate mucosal inspection and polyp removal are performed exclusively on instrument withdrawal. During insertion, minimal mucosal inspection and insufflation are applied to efficiently advance the instrument into cecum. If a polyp is found during insertion, investigators are instructed to make a mental note of it and find it during withdrawal for polypectomy.
Exclusion Criteria:
For participants assigned in the experimental group, the colon is washed and the debris is suctioned as the colonoscopy is slowly inserted from rectum to cecum. Deliberate and systematic inspection of the mucosa is performed with adequate insufflation during both insertion and withdrawal phases.Colon polypectomy for polyp size \<10 mm will be performed when they are identified during insertion and withdrawal of the colonoscope. Colon polypectomy for polyp size \>10 mm will be performed only during withdrawal of the scope.
Procedure: Colon polypectomy
For participants assigned in the control group, deliberate mucosa inspection and colon polypectomy will be performed exclusively on colonoscopy withdrawal.During insertion, minimal mucosal inspection and insufflation are applied to efficiently advance the instrument into cecum.
Procedure: Colon polypectomy
For participants assigned into the experimental group, colon lumen is washed and the debris is suctioned as the colonoscopy is slowly inserted from rectum to cecum. Deliberate and systematic inspection of the mucosa is performed with adequate insufflation during both the insertion and withdrawal phases. Colon polyps with size \<10 mm are removed as they are identified on insertion and withdrawal. Polyps with size \>10 mm are removed only during withdrawal. For participants assigned into the control group, deliberate inspection and polyp removal are performed exclusively on colonoscopy withdrawal.During insertion, minimal mucosal inspection and insufflation are applied to efficiently advance the instrument into cecum.
Percentage of Participants With Detection of at Least One Adenoma Per Procedure
Colon adenoma detection rate is defined as the proportion of colonoscopies where at least one adenoma is found.
Time frame: During procedure, approximately one hour
Mean Colon Adenoma Per Colonoscopy
Mean colon adenoma per procedure is defined as the total number of adenomas detected divided by the number of colonoscopies.
Time frame: During procedure, approximately one hour
| Milestone | Insertion/Withdrawal Colon Polypectomy | Withdrawal Colon Polypectomy |
|---|---|---|
| Started | 214 | 214 |
| Completed | 211 | 210 |
| Not completed | 3 | 4 |
Colon adenoma detection rate is defined as the proportion of colonoscopies where at least one adenoma is found.
| percentage of participants | Insertion/Withdrawal Colon Polypectomy | Withdrawal Colon Polypectomy |
|---|---|---|
| Percentage of Participants With Detection of at Least One Adenoma Per Procedure | 63.7 (56.6 to 70.0) | 68.1 (61.3 to 74.3) |
Mean colon adenoma per procedure is defined as the total number of adenomas detected divided by the number of colonoscopies.
| adenomas/colonoscopy | Insertion/Withdrawal Colon Polypectomy | Withdrawal Colon Polypectomy |
|---|---|---|
| Mean Colon Adenoma Per Colonoscopy | 1.6 ± 2.0 | 1.9 ± 2.4 |
Collected over one month. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Insertion/Withdrawal Colon Polypectomy | 0/211 (0%) | 0/211 (0%) | 0/211 (0%) |
| Withdrawal Colon Polypectomy | 0/210 (0%) | 0/210 (0%) | 0/210 (0%) |
| Age, Continuous(years) | Insertion/Withdrawal Colon Polypectomy | Withdrawal Colon Polypectomy | Total |
|---|---|---|---|
| Mean | 57.6 ± 8.5 | 58.2 ± 8.5 | 57.9 ± 8.5 |
| Sex: Female, Male(Participants) | Insertion/Withdrawal Colon Polypectomy | Withdrawal Colon Polypectomy | Total |
|---|---|---|---|
| Female | 112 | 111 | 223 |
| Male | 99 | 99 | 198 |
| Race (NIH/OMB)(Participants) | Insertion/Withdrawal Colon Polypectomy | Withdrawal Colon Polypectomy | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 211 | 210 | 421 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Insertion/Withdrawal Colon Polypectomy | Withdrawal Colon Polypectomy | Total |
|---|---|---|---|
| Taiwan | 211 | 210 | 421 |
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Evergreen General Hospital, Taiwan