Skip to main content
OpenTrials
Completed

NCT Number: NCT02581475

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

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, 250012, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Extending withdrawal time in the proximal colon

Procedure

Segmental examination twice of the proximal colon

Procedure

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Yanqing Li

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 21, 2015
Registry last updated
Oct 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.