Contact information
Type
Scientific
Primary contact
Mr James Pitt
ORCID ID
Contact details
Department of Surgery
Ipswich Hospital NHS Trust
Heath Road
Ipswich
IP4 5PD
United Kingdom
+44 (0)1473 703755
james.pitt@ipswichhospital.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
04/Q0102/39
Study information
Scientific title
Acronym
Magnesium Trial
Study hypothesis
Not provided at time of registration
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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 names
Magnesium sulphate
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
02/01/2005
Overall trial end date
30/06/2006
Reason abandoned
Never started.
Eligibility
Participant 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.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
108
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
02/01/2005
Recruitment end date
30/06/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Surgery
Ipswich
IP4 5PD
United Kingdom
Sponsor information
Organisation
Ipswich Hospital NHS Trust (UK)
Sponsor details
Heath Road
Ipswich
IP4 5PD
United Kingdom
+44 (0)1473 704343
research.office@ipswichhospital.nhs.uk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
Ipswich Hospital NHS Trust (UK)
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