Randomised Double Blinded Placebo Controlled Trial of Magnesium Sulphate in Reducing Length of Hospital Stay In Patients Undergoing Elective Large Bowel Resection

ISRCTN	ISRCTN72173144
DOI	https://doi.org/10.1186/ISRCTN72173144
Protocol serial number	04/Q0102/39
Sponsor	Ipswich Hospital NHS Trust (UK)
Funder	Ipswich Hospital NHS Trust (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 James Pitt
Scientific

Department of Surgery
Ipswich Hospital NHS Trust
Heath Road
Ipswich
IP4 5PD
United Kingdom

Phone	+44 (0)1473 703755
Email	james.pitt@ipswichhospital.nhs.uk

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	Magnesium Trial
Study objectives	Not provided at time of registration
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Large bowel resection
Intervention	Trial never started. This study aimed to involve patients undergoing elective large bowel resection (right and left hemicolectomy, sigmoid colectomy and anterior resection) at the Ipswich Hospital for benign or malignant disease of the colon and rectum. Patients were to have been randomised to receive either oral magnesium sulphate (1 g oral suspension, twice daily) or a placebo (oral suspension, twice daily) for 5 days. The status of the subjects, whether those taking the active substance or the group taking the placebo drug would not be known by the investigators as this was to be a double blinded study. The pharmacy would produce the inactive placebo.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Magnesium sulphate
Primary outcome measure(s)	Not provided at time of registration
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	30/06/2006
Reason abandoned (if study stopped)	Never started.

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	108
Key inclusion criteria	We intend to recruit 108 subjects initially as follows: A sample size of 54 in each group will have 90% power to detect a probability of 0.319* that an observation in Group 1 is less than an observation in Group 2 using a Wilcoxon (Mann-Whitney) rank-sum test with a 0.050 two-sided significance level. *From a mean length of stay of 6 days in one group (Group 1) and 8 in the other group (Group 2), with a Standard Deviation of 3.000.
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	02/01/2005
Date of final enrolment	30/06/2006

Department of Surgery

Ipswich
IP4 5PD
United Kingdom

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