Clinical Trial: Efficacy of Segmental Examination Twice of the Proximal Colon on Adenoma Detection

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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

Detailed Summary:

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.


Sponsor: Yanqing Li

Current Primary Outcome: Difference of Adenoma Detection Rate in the Proximal Colon Among 2 Group. [ 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. ]

Adenoma detection rate in the proximal colon was the proportion of participants wiht more than one adenomas in proximal colon.


Original Primary Outcome: Difference of adenoma detection rate in the proximal colon among 3 group. [ Time Frame: 12 months ]

Current Secondary Outcome:

  • 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. ]


Original Secondary Outcome:

  • Withdrawal time in the proximal colon among 3 group. [ Time Frame: 12 months ]
  • Duration of the total colonoscopy among 3 group. [ Time Frame: 12 months ]
  • Adenomas per patient in the proximal colon among 3 group. [ Time Frame: 12 months ]


Information By: Shandong University

Dates:
Date Received: October 19, 2015
Date Started: November 2015
Date Completion:
Last Updated: August 26, 2016
Last Verified: August 2016