Italian multicentre randomised controlled trial of 'once-only sigmoidoscopy'

Not Applicable

Completed

• Conditions: Colorectal cancer screening; Cancer; Colorectal cancer

• Registration Number: ISRCTN27814061
• Lead Sponsor: Italian Association for Cancer Research (Associazione Italiana per la Ricerca sul Cancro [AIRC]) (Italy)

Brief Summary

2002 Other publications in http://www.ncbi.nlm.nih.gov/pubmed/12464648 baseline findings 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34748376/ (added 10/11/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 1998-06-30
• Study Start: 2010-12-08
• Last Update Posted: 22 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 34272

Inclusion Criteria

Eligible, interested respondents to a mail questionnaire sent to a random population sample of men and women aged 55 to 64 years.

Exclusion Criteria

1. Personal history of colorectal cancer, adenomas, inflammatory bowel disease, recent colorectal endoscopy
2. Subjects mentioning two first-degree relatives with colorectal cancer
3. Subjects unable to give informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To quantify the reduction in CRC incidence (measured at 10 years) and mortality (measured at 11 years).

Secondary Outcome Measures

Name	Time	Method
<br> 1. To determine the duration of efficacy of a single flexible sigmoidoscopy, measured up to 15 years from randomisation<br> 2. To determine the optimum age for the examination, measured at 10 and 11 years<br> 3. To assess acceptability and organisational impact (evaluated in the recruitment phase)<br>