Trial Information
Prospective, Double-Blinded, Multi-Centred, Randomised Controlled Trial of Perioperative Simvastatin Use in Elective Colorectal Surgery
Inclusion Criteria
Inclusion criteria:
- Consecutive consenting patients undergoing elective colectomy, rectal resection, and
reversal of Hartmann's procedure at Middlemore Hospital, Manukau Surgery Centre,
Auckland City Hospital, and North Shore Hospital.
Exclusion criteria:
- Acute presentation
- Already taking statins or other lipid-lowering medication
- Known adverse reaction to statins
- Hepatic dysfunction
- Moderate to severe renal dysfunction
- Previous history of rhabdomyolysis
- On contraindicated medication
- Pregnancy
- Breastfeeding
- Patient choice.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Total complications
Outcome Description:
Complications pre-defined and graded by the Clavien-Dindo classification
Outcome Time Frame:
Up to post-operative day 30
Safety Issue:
No
Principal Investigator
Andrew G Hill, Assoc Prof
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Auckland, New Zealand
Authority:
New Zealand: Health and Disability Ethics Committees
Study ID:
StatCol
NCT ID:
NCT00994903
Start Date:
October 2011
Completion Date:
November 2013
Related Keywords:
- Intestinal Neoplasm
- Perioperative Care
- Statin
- Colon
- Colorectal
- Intestinal Neoplasms
- ERAS
- Perioperative Care
- Neoplasms
- Intestinal Neoplasms