A prospective randomised controlled trial evaluating pre-clinic telephone advice for patients referred to a rectal bleed clinic

ISRCTN	ISRCTN46230767
DOI	https://doi.org/10.1186/ISRCTN46230767
Protocol serial number	N0277122006
Sponsor	Department of Health (UK)
Funder	Whittington Hospital NHS Trust (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Ms Tracey Irvine
Scientific

General Surgery
Whittington Hospital
Highgate Hill
London
N19 5NF
United Kingdom

Phone	+44 (0)20 7288 3938

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	To see if outpatient attendances for patients with benign rectal bleeding can be reduced with pre-clinic telephone advice.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Colorectal bleeding
Intervention	Group 1: Telephone Questionnaire + Advice. The Colorectal Nurse Practitioner contacts patients by phone and patients that are felt to have benign rectal bleeding are given telephone advice. They are contacted 6 weeks later and if still symptomatic are brought into the clinic. If patients are symptom free they decide whether they require an appointment. They receive a letter giving further advice and that they may come to the clinic if symptoms reoccur. Group 2: Routine Outpatient Attendance + Questionnaire. These patients attend clinic as planned. They fill in the questionnaire and will be examined and treated in the usual way.
Intervention type	Other
Primary outcome measure(s)	Number of patients still requiring outpatient visits after telephone advice.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/10/2004

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	60
Key inclusion criteria	1. patients with rectal bleeding referred to colorectal specialist clinic 2. young adults - under 40 years of age 3. low risk of colorectal cancer = 60
Key exclusion criteria	Does not match inclusion criteria
Date of first enrolment	06/02/2003
Date of final enrolment	31/10/2004

General Surgery

London
N19 5NF
United Kingdom

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	01/01/2007		Yes	No