Self-collection of stool: an alternative to digital rectal examination for faecal occult blood testing in the emergency department (ED)
ISRCTN | ISRCTN93236187 |
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DOI | https://doi.org/10.1186/ISRCTN93236187 |
Secondary identifying numbers | N/A |
- Submission date
- 23/11/2005
- Registration date
- 25/11/2005
- Last edited
- 16/01/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Paris Lovett
Scientific
Scientific
545 West 111th Street
New York
10025
United States of America
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Not Specified |
Scientific title | Self-collection of stool: an alternative to digital rectal examination for faecal occult blood testing in the emergency department (ED) |
Study objectives | Self-Collection of Stool (SCS) causes equal degrees of pain/discomfort and produces equally adequate specimens for occult blood testing when compared with the traditional technique employed in the Emergency Department - Digital Rectal Examination (DRE) |
Ethics approval(s) | Institutional Review Board of Beth Israel Medical Center, New York, NY, with written consent required |
Health condition(s) or problem(s) studied | Stool Collection for Occult Blood Testing |
Intervention | Stool Collection using either traditional DRE technique or new technique under study (SCS). |
Intervention type | Other |
Primary outcome measure | Pain/Discomfort, measured on a 100 mm Visual Analog Scale (VAS) |
Secondary outcome measures | Adequacy of Specimen for Guaiac Testing |
Overall study start date | 02/01/2004 |
Completion date | 30/05/2004 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | 28 |
Key inclusion criteria | All patients 18 years and older for whom the treating Emergency Physician (EP) had made a decision to collect stool were interviewed for enrollment. |
Key exclusion criteria | Subjects were excluded from enrollment if there was some indication that DRE instead of SCS would provide additional clinical information which might determine diagnosis or management. Such exclusions comprised patients with presenting complaints of anal or rectal pain, anal or rectal masses or swelling, possible spinal injury, prostatic disease, or urinary retention. Patients were also excluded if they were unable to give written consent in English, if they were judged incapable of performing SCS, or if stool had already been obtained. |
Date of first enrolment | 02/01/2004 |
Date of final enrolment | 30/05/2004 |
Locations
Countries of recruitment
- United States of America
Study participating centre
545 West 111th Street
New York
10025
United States of America
10025
United States of America
Sponsor information
New York-Presbyterian - University Hospital of Columbia and Cornell and Beth Israel Medical Center (USA)
Hospital/treatment centre
Hospital/treatment centre
545 West 111th Street
New York
10025
United States of America
https://ror.org/03gzbrs57 |
Funders
Funder type
Hospital/treatment centre
Beth Israel Medical Centre (Israel)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | 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 | 01/09/2005 | 16/01/2020 | Yes | No |
Editorial Notes
16/01/2020: Publication reference added.