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Colonoscopic Adenoma and Advanced Neoplasia Detection Rates According to Age

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ClinicalTrials.gov Identifier: NCT03361904
Recruitment Status : Completed
First Posted : December 5, 2017
Last Update Posted : December 5, 2017
Sponsor:
Information provided by (Responsible Party):
KARSENTI, Société Française d'Endoscopie Digestive

Study Description
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Brief Summary:

Current recommendations for colonoscopy screening programs usually involve patients older than 50 years of age. However, little is known about polyp or adenoma detection rates under 50. We compared these detection rates according to age in a large series of patients in common practice.

Methods: All colonoscopies performed in 2016 in our unit were prospectively recorded. We determined adenoma detection rate (ADR), polyp detection rate (PDR), mean number of polyps (MNP), and advanced neoplasia detection rate (ANDR).


Condition or disease Intervention/treatment
Colonic Polyp Colon Adenoma Colonoscopy Colon Cancer Age Procedure: Colonoscopy

Detailed Description:

Patients All consecutive patients who were scheduled for colonoscopy were included. Exclusion criteria were: patients scheduled for partial colonoscopy, interventional colonoscopy (for stent insertion, stenosis dilation).

Data collection The following data have been prospectively collected: age, gender, indication for colonoscopy, preparation procedure and quality of the preparation (assessed by the Boston Bowel Preparation Scale; BBPS) [19-20], caecal intubation (yes/no), withdrawal time, number and size of polyps and polyp histopathology.

All clinical data were collected during the procedure by a nurse and an endoscopist on a dedicated software. The database was then supplemented by the Clinical Research Associate for histopathological data.

We determined adenoma detection rate (ADR; percentage of colonoscopies with at least one adenoma), polyp detection rate (PDR: percentage of colonoscopies with at least one polyp), mean number of polyps per colonoscopy (MNP), large polyp detection rate (LPDR; percentage of colonoscopies with at least one polyp of 1 cm or more) and advanced neoplasia detection rate (ANDR: percentage of colonoscopies with at least one advanced neoplastic lesion as defined below).

Study Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 6027 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 7 Days
Official Title: Adenoma and Advanced Neoplasia Detection Rates Increase From 45 Year of Age: Results of a Monocentric One-year Observational Cohort Study on 6027 Colonoscopies
Actual Study Start Date : January 1, 2016
Actual Primary Completion Date : December 31, 2016
Actual Study Completion Date : December 31, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Groups and Cohorts
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Intervention Details:
  • Procedure: Colonoscopy
    Total colonoscopy : All consecutive patients who were scheduled for colonoscopy were included. Exclusion criteria were: patients scheduled for partial colonoscopy, interventional colonoscopy (for stent insertion, stenosis dilation).

Outcome Measures
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Primary Outcome Measures :
  1. Adenoma detection rate according to age [ Time Frame: during colonoscopy ]
    ADR <30yo, in 30-34 yo, in 35-39yo, in 40-44yo, in 45-49yo, in 50-54yo, in 55-59yo, in 60-64yo, in 65-69 yo, in 70-74yo, in 75-79yo and >79yo intervals

  2. Advanced Neoplasia Detection rate according to age [ Time Frame: during colonoscopy ]
    ANDR <30yo, in 30-34 yo, in 35-39yo, in 40-44yo, in 45-49yo, in 50-54yo, in 55-59yo, in 60-64yo, in 65-69 yo, in 70-74yo, in 75-79yo and >79yo intervals


Secondary Outcome Measures :
  1. Age [ Time Frame: during colonoscopy ]
    years old

  2. Gender [ Time Frame: during colonoscopy ]
    Male or Female

  3. Indication for colonoscopy [ Time Frame: during colonoscopy ]
    pain / screening/ familial or personal history of polyp or cancer

  4. quality of the preparation [ Time Frame: during colonoscopy ]

    Boston Bowel Preparation Scale Segment Score Description 0: unprepared colon segment with mucosa not senn due to solid stool that cannot be cleared

    1. Portion of mucosa of the colon segment seen, but other areas of the colon segment are not well seen due to staining, residual stool, and/or opaque liquid
    2. minor amount of residual staining, small fragments of stool, and/or opaque liquid, but mucosa of colon segments is seen well
    3. entire mucosa of colon segment seen well, with no residual staining, small fragments of stool or opaque liquid

    Total score is a summation of scores from three segments of the colon Score is from 0 to 9


  5. Caecal intubation [ Time Frame: during colonoscopy ]
    Y/N

  6. Withdrawal time [ Time Frame: during colonoscopy ]
    in seconds


Eligibility Criteria
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Ages Eligible for Study:   15 Years to 99 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
During the study period, 6335 colorectal endoscopic procedures were realized in the endoscopy unit. We excluded 278 sigmoidoscopies and 30 interventional procedures for stent insertion or stenosis dilation. Only diagnostic colonoscopies were recorded, performed in 3308 women (54.9%) and 2719 men (45.1%) with a median age of 57 (range, 15-96: IQR 18).
Criteria

Inclusion Criteria:

  • All consecutive patients who were scheduled for colonoscopy were included.

Exclusion Criteria:

  • patients scheduled for partial colonoscopy, interventional colonoscopy (for stent insertion, stenosis dilation).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03361904


Sponsors and Collaborators
Société Française d'Endoscopie Digestive
Investigators
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Principal Investigator: David Karsenti, MD Pole Digestif Paris-Bercy
More Information
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Additional Information:

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Responsible Party: KARSENTI, principal investigator, Société Française d'Endoscopie Digestive
ClinicalTrials.gov Identifier: NCT03361904    
Other Study ID Numbers: 2016-ADR according to age
First Posted: December 5, 2017    Key Record Dates
Last Update Posted: December 5, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Adenoma
Colonic Polyps
Neoplasms
Neoplasms, Glandular and Epithelial
 Neoplasms by Histologic Type
Intestinal Polyps
Polyps
Pathological Conditions, Anatomical