Does the choice of suture material affect outcome in the formulation of an intestinal stoma?

ISRCTN	ISRCTN08115057
DOI	https://doi.org/10.1186/ISRCTN08115057
Protocol serial number	N0283122687
Sponsor	Department of Health (UK)
Funder	Sussex NHS Research Consortium (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Mr William Woods
Scientific

Worthing & Southlands Hospitals NHS Trust
Worthing Hospital
Lyndhurst Road
Worthing, West Sussex
BN11 2DH
United Kingdom

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Is there any difference in terms of complication rate or ease of use with three of the commonly used sutures for stoma formation?
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Surgery: Laparotomy
Intervention	This is a single centre prospective randomized controlled trial comparing the complication rates of vicryl, polydioxanone suture (PDS) or biosyn.
Intervention type	Procedure/Surgery
Primary outcome measure(s)	Primary outcome measures are numbers of complications.
Key secondary outcome measure(s)	Length of hospital stay and time to independence in managing the stoma.
Completion date	30/10/2006

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	90
Key inclusion criteria	90 consenting patients due to undergo a laparotomy will be prospectively randomized into three groups.
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	16/10/2002
Date of final enrolment	30/10/2006

Worthing & Southlands Hospitals NHS Trust

Worthing, West Sussex
BN11 2DH
United Kingdom

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