Double blind prospective randomised controlled trial of antibiotic prophylaxis for percutaneous endoscopic gastrostomy (PEG)

ISRCTN	ISRCTN53943193
DOI	https://doi.org/10.1186/ISRCTN53943193
Protocol serial number	N0557099429
Sponsor	Department of Health (UK)
Funder	The Dudley Group of Hospitals NHS Trust (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr BJM Jones
Scientific

Department of Gastroenterology
Russells Hall Hospital
Dudley
DY1 2HQ
United Kingdom

Phone	+44 01384 244074
Email	b.j.m.j@btinternet.com

Primary study design	Interventional
Study design	Double blind prospective randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Does antibiotic prophylaxis reduce post PEG sepsis compared to placebo in a cohort of British district general hospital patients?
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Injury, Occupational Diseases, Poisoning: Post percutaneous endoscopic gastrostomy sepsis
Intervention	1. Antibiotic 2. Placebo
Intervention type	Other
Primary outcome measure(s)	One week post procedure, sepsis present (graded) or sepsis free.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/12/2005

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	200
Key inclusion criteria	200 patients referred for PEG insertion.
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/08/2001
Date of final enrolment	31/12/2005

Department of Gastroenterology

Dudley
DY1 2HQ
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	15/09/2005		Yes	No