Comparing colonoscopy, sigmoidoscopy and fecal occult blood test for colorectal cancer screening
| ISRCTN | ISRCTN41742401 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN41742401 |
| Protocol serial number | N/A |
| Sponsor | Italian League Against Cancer (LILT) (Italy) |
| Funders | Support for the study was provided by:, Grant from the Italian League against Cancer (LILT) (Italy) (Letter protocol number: 2001/3081/Sa/lr), The following provided additional resources for the implementation of the study in Rimini, Biella, Milan, Verona and Turin, respectively:, a. Piedmont Regional Health Authority (Italy), b. ULSS 20 Verona (Italy), c. University of Milan (Italy), d. Fondo "E Tempia" (Italy), e. Istituto Oncologico Romagnolo (IOR) (Italy), SOFAR s.p.a. (Italy) provided the enemas for the bowel preparation |
- Submission date
- 10/07/2006
- Registration date
- 28/07/2006
- Last edited
- 11/11/2009
- 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
Scientific
CPO Piemonte and ASO San Giovanni Battista
Via San Francesco da Paola, 31
Turin
10123
Italy
| Phone | +39 011 633 3860 |
|---|---|
| nereo.segnan@cpo.it |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Interventional randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | SCORE 3 (Screening COloREctal) |
| Study objectives | Comparisons of attendance, detection rates and acceptability of total colonoscopy, flexible sigmoidoscopy and fecal occult blood test (FOBT) as primary screening tests for colorectal cancer. |
| Ethics approval(s) | Piedmont region ethics board, date of approval: 17/06/2002 (ref: 8151/28.3) |
| Health condition(s) or problem(s) studied | Colorectal cancer, colorectal polyps |
| Intervention | Patients, after informed consent, were individually randomized from rosters of GPs or from residents in specific districts or city neighborhoods, either to total colonoscopy or flexible sigmoidoscopy or FOBT. 1. Colonoscopy: oral bowel preparation with sodium phosphate solution (two litres). Mild dietary restrictions (i.e. to increase the uptake of water and to reduce consumption of foods rich in fibers the day before the test) recommended. Colonoscopy performed by gastroenterologists in hospital endoscopy units. No standard protocol for sedation. If the baseline colonoscopy could not be completed to the cecum, the patients were referred for a Double Contrast Barium Enema (DCBE), whenever advanced adenomas (see Polyp classification) were detected in the segments examined. DCBE was not routinely indicated in the case of a negative incomplete colonoscopy, due to patient's intolerance. 2. Sigmoidoscopy: bowel preparation was limited to a single enema (133 ml of 22% sodium phosphate) self-administered at home two hours before the test. No dietary restriction recommended. Screening undertaken by gastroenterologists in hospital endoscopy units. Aim of the examination: to advance the endoscope beyond the sigmoid-descending colon junction under adequate bowel preparation. Polyps smaller than 10 mm detected during the flexible sigmoidoscopy were removed immediately and sent for histological assessment. Subjects with polyps larger than or equal to 10 mm, as well as those detected with advanced adenomas (see polyp classification) referred for total colonoscopy. Subjects with suspected colorectal cancer or with polyps too large to be removed endoscopically referred for surgery. 3. FOBT: immunochemical test performed on a single sample without any dietary restriction. All cards stored at 4°C and shipped weekly to one central laboratory (Laboratorio di Citopatologia, CSPO - Florence). Patients with positive test called by the study staff and they are offered an appointment date for a total colonoscopy. |
| Intervention type | Other |
| Primary outcome measure(s) |
Attendance and detection rate to total colonoscopy, flexible sigmoidoscopy and FOBT as primary screening tests. |
| Key secondary outcome measure(s) |
Acceptability, complication rates, side effects and costs associated with screening procedures. |
| Completion date | 31/01/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 18000 |
| Key inclusion criteria | Men and women aged 55 to 64 who had not been recruited in previous SCORE trials (SCORE and SCORE 2). |
| Key exclusion criteria | 1. Patients unable to give informed consent 2. Patients with terminal illness, inflammatory bowel disease, personal history of polyps or colorectal cancer 3. Patients with two first degree relatives with colorectal cancer 4. Patients who had a colorectal endoscopy or FOBT within the previous two years |
| Date of first enrolment | 01/10/2002 |
| Date of final enrolment | 31/01/2004 |
Locations
Countries of recruitment
- Italy
Study participating centre
CPO Piemonte and ASO San Giovanni Battista
Turin
10123
Italy
10123
Italy
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/06/2007 | Yes | No |
