Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
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
Institutional Review Board of Beth Israel Medical Center, New York, NY, with written consent required
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Stool Collection for Occult Blood Testing
Intervention
Stool Collection using either traditional DRE technique or new technique under study (SCS).
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Pain/Discomfort, measured on a 100 mm Visual Analog Scale (VAS)
Secondary outcome measures
Adequacy of Specimen for Guaiac Testing
Overall trial start date
02/01/2004
Overall trial end date
30/05/2004
Reason abandoned (if study stopped)
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
28
Participant 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.
Recruitment start date
02/01/2004
Recruitment end date
30/05/2004
Locations
Countries of recruitment
United States of America
Trial participating centre
545 West 111th Street
New York
10025
United States of America
Funders
Funder type
Hospital/treatment centre
Funder name
Beth Israel Medical Centre (Israel)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
P.B. Lovett, J.D. D'Angelo, K.M. Stürmann, P. Homel and H. Cho. Self-Collection of Stool: An Alternative to Digital Rectal Examination for Fecal Occult Blood Testing in the Emergency Department ABSTRACT. Annals of Emergency Medicine, Volume 46, Issue 3, Supplement 1, September 2005, Page 65.