Colonic Polyps
Conditions
Keywords
Adenoma detection rate, Colonoscopy, Withdrawal time
Brief summary
Segmental examination twice of the proximal colon might be helpful to increase adenoma detection rate (ADR).
Detailed description
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.
Interventions
PROCEDUREExtending withdrawal time in the proximal colon
PROCEDURESegmental examination twice of the proximal colon
Sponsors
Yanqing Li
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Asia-Pacific Colorectal Screening score ≥2, such as patients ≥ 50 years, patients with a family history of colorectal cancer in a first-degree relative or male patients with current or past smoking.
Exclusion criteria
* Patients with prior resection of the proximal colon, advanced colonic cancer, inflammatory bowel disease, or polyposis syndrome. * The cecum could not be intubated. * Inadequate bowel preparation (Boston Bowel Preparation Scale score \<2 in any segment of the colon). * Biopsies were not available. * Unable to provide informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference of Adenoma Detection Rate in the Proximal Colon Among 2 Group. | 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. | Adenoma detection rate in the proximal colon was the proportion of participants wiht more than one adenomas in proximal colon. |
Secondary
| Measure | Time frame |
|---|---|
| Withdrawal Time in the Proximal Colon Among 2 Group. | 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. | 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. | 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. |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Extending Withdrawal Time After cecal intubation, the colonoscopy is withdrawn to the hepatic flexure and then to the splenic flexure with an extended withdrawal time during colonoscopy. | 182 |
| Segmental Examination Twice 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. | 178 |
| Total | 360 |
Baseline characteristics
| Characteristic | Extending Withdrawal Time | Segmental Examination Twice | Total |
|---|---|---|---|
| Age, Continuous | 54.9 years STANDARD_DEVIATION 10.3 | 55.0 years STANDARD_DEVIATION 11 | 54.9 years STANDARD_DEVIATION 10.7 |
| Sex: Female, Male Female | 80 Participants | 83 Participants | 163 Participants |
| Sex: Female, Male Male | 102 Participants | 95 Participants | 197 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 182 | 0 / 178 |
| serious Total, serious adverse events | 0 / 182 | 0 / 178 |
Outcome results
Primary
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Extending Withdrawal Time | Difference of Adenoma Detection Rate in the Proximal Colon Among 2 Group. | 0.236 proportion of participants |
| Segmental Examination Twice | Difference of Adenoma Detection Rate in the Proximal Colon Among 2 Group. | 0.331 proportion of participants |
Secondary
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Extending Withdrawal Time | Adenomas Per Patient in the Proximal Colon Among 2 Group. | 0.36 adenomas per patient | Standard Deviation 0.704 |
| Segmental Examination Twice | Adenomas Per Patient in the Proximal Colon Among 2 Group. | 0.54 adenomas per patient | Standard Deviation 0.921 |
Secondary
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Extending Withdrawal Time | Duration of the Total Colonoscopy Among 2 Group. | 16.98 minute | Standard Deviation 4.92 |
| Segmental Examination Twice | Duration of the Total Colonoscopy Among 2 Group. | 17.45 minute | Standard Deviation 5.25 |
Secondary
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Extending Withdrawal Time | Withdrawal Time in the Proximal Colon Among 2 Group. | 4.34 minute | Standard Deviation 1.36 |
| Segmental Examination Twice | Withdrawal Time in the Proximal Colon Among 2 Group. | 4.29 minute | Standard Deviation 1.23 |