Efficacy of Segmental Examination Twice of the Proximal Colon on Adenoma Detection

Study Overview
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Brief Summary
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Segmental examination twice of the proximal colon might be helpful to increase adenoma detection rate (ADR).

Detailed Description
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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.

Official Title
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Efficacy of Segmental Examination Twice of Proximal Colon on Adenoma Detection: a Prospective, Randomized, Controlled Study

Conditions
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Colonic Polyps

Intervention / Treatment
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* Procedure: Extending withdrawal time in the proximal colon
* Procedure: Segmental examination twice of the proximal colon


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A<br>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<br> <br> |
| Experimental: Group B<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adenoma detection rate, Colonoscopy, Withdrawal time