Condition category
Not Applicable
Date applied
23/11/2005
Date assigned
25/11/2005
Last edited
11/09/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Paris Lovett

ORCID ID

Contact details

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

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 measures

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

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

Sponsor information

Organisation

New York-Presbyterian - University Hospital of Columbia and Cornell and Beth Israel Medical Center (USA)

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

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

Results - basic reporting

Publication summary

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.

Publication citations

Additional files

Editorial Notes