Condition category
Digestive System
Date applied
03/12/2004
Date assigned
21/02/2005
Last edited
16/06/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

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

Publication citations

Additional files

Editorial Notes