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

ISRCTN ISRCTN27814061
DOI https://doi.org/10.1186/ISRCTN27814061
Secondary identifying numbers N/A
Submission date
10/11/2010
Registration date
08/12/2010
Last edited
10/11/2021
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Nereo Segnan
Scientific

Via S Francesco da Paola 31
Turin
10123
Italy

Email nereo.segnan@cpo.it

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleRandomised controlled trial evaluating efficacy of 'one-only sigmoidoscopy' screening for colorectal cancer
Study acronymSCORE
Study objectivesThe incidence of distal adenomas reaches a plateau at around age 60 years. Therefore, a single sigmoidoscopy followed by colonoscopy in people with high-risk distal adenomas may offer a long lasting protection.
Ethics approval(s)Local co-ordinating committees approved following approval from the Delibera Azienda USL 1 Torino on the 14th June 1995 (ref: 982/07/95)
Health condition(s) or problem(s) studiedColorectal cancer screening
InterventionSigmoidoscopy 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 before the test. No dietary restriction recommended. Screening undertaken by gastroenterologists in hospital endoscopy units. Aim of the examination was to advance the endoscope beyond the sigmoid-descending colon junction under adequate bowel preparation. Polyps less than 6 mm detected during the FS were removed immediately and sent for histological examination. Subjects with polyps larger than 5 mm, or with advanced adenomas (see polyp classification) referred for TC. Subjects with suspected CRC or with polyps too large to be removed endoscopically referred for surgery.

Joint sponsor details:
Italian National Research Council (CNR) (Italy)
Piazzale Aldo Moro, 7
00185, Roma
Italy
T: +39 (0)6 49 931
F: +39 (0)6 44 619 54
E: cnr@pec.cnr.it
http://www.cnr.it
Intervention typeOther
Primary outcome measureTo quantify the reduction in CRC incidence (measured at 10 years) and mortality (measured at 11 years).
Secondary outcome measures1. 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)
Overall study start date01/10/1995
Completion date30/06/1998

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants40,000
Total final enrolment34272
Key inclusion criteriaEligible, interested respondents to a mail questionnaire sent to a random population sample of men and women aged 55 to 64 years.
Key exclusion criteria1. 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
Date of first enrolment01/10/1995
Date of final enrolment30/06/1998

Locations

Countries of recruitment

  • Italy

Study participating centre

Via S Francesco da Paola 31
Turin
10123
Italy

Sponsor information

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

Via Corridoni 7
Milano
20122
Italy

Email nereo.segnan@cpo.it
Website http://www.airc.it
ROR logo "ROR" https://ror.org/02g2x7380

Funders

Funder type

Research organisation

Support for the study was provided by grants from:

No information available

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

No information available

Italian National Research Council (CNR) (Italy) (ref: 95.00539.PF39, 96.00736.PF39)

No information available

The following provided additional resources for the implementation of the study in Rimini, Biella, Milano and Torino, respectively:

No information available

Romagnolo Cancer Institute (Istituto Oncologico Romagnolo [IOR]) (Italy)

No information available

Edo Tempia Fund (Fondo Edo Tempia) (Italy)

No information available

University of Milan (Università degli Studi di Milano) (Italy)

No information available

Local Health Unit (Azienda Sanitaria Locale [ASL]) 1, Torino (Italy)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing planNot provided at time of registration

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Other publications baseline findings 04/12/2002 Yes No
Results article 09/11/2021 10/11/2021 Yes No

Editorial Notes

10/11/2021: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.