An interventional study of Extending withdrawal time in the proximal colon and Segmental examination twice of the proximal colon in Colonic Polyps, sponsored by Yanqing Li. Completed at 1 site in China. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-10-19.
Sponsored by Yanqing Li · Not applicable, Interventional, and Prevention
Segmental examination twice of the proximal colon might be helpful to increase adenoma detection rate (ADR).
Colonoscopy is the gold standard screening test for colorectal cancer (CRC). Removal of adenomas can reduce the incidence and mortality of CRC. However, there is evidence that some patients may develop interval cancers-cancers developed within 3-5 years following colonoscopy and polypectomy. The overall rate of interval cancer was 1.1-2.7 per 1000 person-years. Several studies have suggested that patients who develop interval cancers are more likely to have proximal compared than distal cancers.
One hypothesis is that adenomas may be more likely to be missed in the proximal colon compared with the distal colon. Serrated polyps and some adenomas in the proximal colon may be difficult to detect if they are flat, covered with mucus, or behind folds. A second hypothesis is that neoplastic lesions of the proximal colon may biologically differ from distal lesions and progress to malignancy with a short dwell time.
Several tandem back to back colonoscopy studies have demonstrated that up to 27% adenomas in the proximal colon are missed during routine screening colonoscopy. Hover, examining the colon twice as that in the back to back studies is difficult to be performed in clinical practice. Thus, we developed a novel colonoscopy technique, segmental examination twice of the proximal colon, that is simple and easy to be performed. The current study aims to examine the efficacy of segmental examination twice of the proximal colon on adenoma detection rate (ADR) during routine screening and surveillance colonoscopy.
657 studies on the registry are indexed under Adenoma; 98 are open to participants now.
This study's enrollment of 386 is above the median of 250 across 412 interventional studies indexed under Adenoma.
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Exclusion Criteria:
Extending withdrawal time in the proximal colon: After cecal intubation, the colonoscopy is withdrawn to the hepatic flexure and then to the splenic flexure with an extended withdrawal time during colonoscopy. From cecum to hepatic flexure, 1.5-2 min is required and 2.5-3 min is required from heptic flexure to splenic flexure.
Procedure: Extending withdrawal time in the proximal colon
Segmental examination twice of the proximal colon: After cecal intubation, the colonoscopy is withdrawn to the hepatic flexure and then the colonoscopy is intubated to the cecum again. The same procedure is performed in the colonic segment from hepatic flexure to splenic flexure. The withdrawal time in each colonic segment is similar to the group A.
Procedure: Segmental examination twice of the proximal colon
Difference of Adenoma Detection Rate in the Proximal Colon Among 2 Group.
Adenoma detection rate in the proximal colon was the proportion of participants wiht more than one adenomas in proximal colon.
Time frame: During routine screening and surveillance colonoscopy, for up to 1 hour, number of adenomas was recorded. About 1 month after this study, adenoma detetion rates were calculated.
Withdrawal Time in the Proximal Colon Among 2 Group.
Time frame: During routine screening and surveillance colonoscopy, for up to 1 hour, withdrawal time was recorded. About 1 month after this study, mean withdrawal time was calculated.
Duration of the Total Colonoscopy Among 2 Group.
Time frame: During routine screening and surveillance colonoscopy, for up to 1 hour, the duration of colonoscopy was recorded. About 1 month after this study, mean duration of the colonoscopy was calculated.
Adenomas Per Patient in the Proximal Colon Among 2 Group.
Time frame: During routine screening and surveillance colonoscopy, for up toafter 1 hour, the number of adenomas was recorded. About 1 month after this study, mean number of adenomas in proximal colon was calculated.
| Milestone | Extending Withdrawal Time | Segmental Examination Twice |
|---|---|---|
| Started | 193 | 193 |
| Completed | 182 | 178 |
| Not completed | 11 | 15 |
Adenoma detection rate in the proximal colon was the proportion of participants wiht more than one adenomas in proximal colon.
| proportion of participants | Extending Withdrawal Time | Segmental Examination Twice |
|---|---|---|
| Difference of Adenoma Detection Rate in the Proximal Colon Among 2 Group. | 0.236 (0.175 to 0.298) | 0.331 (0.262 to 0.4) |
| minute | Extending Withdrawal Time | Segmental Examination Twice |
|---|---|---|
| Withdrawal Time in the Proximal Colon Among 2 Group. | 4.34 ± 1.36 | 4.29 ± 1.23 |
| minute | Extending Withdrawal Time | Segmental Examination Twice |
|---|---|---|
| Duration of the Total Colonoscopy Among 2 Group. | 16.98 ± 4.92 | 17.45 ± 5.25 |
| adenomas per patient | Extending Withdrawal Time | Segmental Examination Twice |
|---|---|---|
| Adenomas Per Patient in the Proximal Colon Among 2 Group. | 0.36 ± 0.704 | 0.54 ± 0.921 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Extending Withdrawal Time | — | 0/182 (0%) | 0/182 (0%) |
| Segmental Examination Twice | — | 0/178 (0%) | 0/178 (0%) |
| Age, Continuous(years) | Extending Withdrawal Time | Segmental Examination Twice | Total |
|---|---|---|---|
| Mean | 54.9 ± 10.3 | 55.0 ± 11.0 | 54.9 ± 10.7 |
| Sex: Female, Male(Participants) | Extending Withdrawal Time | Segmental Examination Twice | Total |
|---|---|---|---|
| Female | 80 | 83 | 163 |
| Male | 102 | 95 | 197 |
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