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

Randomised controlled trial evaluating efficacy of 'one-only sigmoidoscopy' screening for colorectal cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN27814061
Enrollment
40000
Registered
2010-12-08
Start date
1995-10-01
Completion date
Unknown
Last updated
2021-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal cancer screening Cancer Colorectal cancer

Interventions

Sigmoidoscopy offered once in the life in the intervention group
usual care in the control group. Sigmoidoscopy: Bowel preparation was limited to a single enema (133 ml of 22% sodium phosphate) self-administered at home 2 hours befo

Sponsors

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

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
To quantify the reduction in CRC incidence (measured at 10 years) and mortality (measured at 11 years).

Secondary

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

Countries

Italy

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026