Self-collection of stool: an alternative to digital rectal examination for faecal occult blood testing in the emergency department (ED)

ISRCTN ISRCTN93236187
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

545 West 111th Street
New York
10025
United States of America

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific titleSelf-collection of stool: an alternative to digital rectal examination for faecal occult blood testing in the emergency department (ED)
Study objectivesSelf-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) studiedStool Collection for Occult Blood Testing
InterventionStool Collection using either traditional DRE technique or new technique under study (SCS).
Intervention typeOther
Primary outcome measurePain/Discomfort, measured on a 100 mm Visual Analog Scale (VAS)
Secondary outcome measuresAdequacy of Specimen for Guaiac Testing
Overall study start date02/01/2004
Completion date30/05/2004

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants28
Key inclusion criteriaAll 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 criteriaSubjects 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 enrolment02/01/2004
Date of final enrolment30/05/2004

Locations

Countries of recruitment

  • United States of America

Study participating centre

545 West 111th Street
New York
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

545 West 111th Street
New York
10025
United States of America

ROR logo "ROR" 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
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 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.