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 |
| Secondary identifying numbers | 04/Q0102/39 |
- Submission date
- 03/12/2004
- Registration date
- 21/02/2005
- Last edited
- 16/06/2011
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Digestive System
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
Contact information
Mr James Pitt
Scientific
Scientific
Department of Surgery
Ipswich Hospital NHS Trust
Heath Road
Ipswich
IP4 5PD
United Kingdom
| Phone | +44 (0)1473 703755 |
|---|---|
| james.pitt@ipswichhospital.nhs.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Magnesium sulphate |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 02/01/2005 |
| Completion date | 30/06/2006 |
| Reason abandoned (if study stopped) | Never started. |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 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 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Surgery
Ipswich
IP4 5PD
United Kingdom
IP4 5PD
United Kingdom
Sponsor information
Ipswich Hospital NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Heath Road
Ipswich
IP4 5PD
England
United Kingdom
| Phone | +44 (0)1473 704343 |
|---|---|
| research.office@ipswichhospital.nhs.uk |
Funders
Funder type
Government
Ipswich Hospital NHS Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
