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
Protocol serial number	N/A
Sponsor	New York-Presbyterian - University Hospital of Columbia and Cornell and Beth Israel Medical Center (USA)
Funder	Beth Israel Medical Centre (Israel)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Paris Lovett
Scientific

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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(s)	Pain/Discomfort, measured on a 100 mm Visual Analog Scale (VAS)
Key secondary outcome measure(s)	Adequacy of Specimen for Guaiac Testing
Completion date	30/05/2004

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	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

545 West 111th Street

New York
10025
United States of America

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/09/2005	16/01/2020	Yes	No

16/01/2020: Publication reference added.