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Prospective, Double-Blinded, Multi-Centred, Randomised Controlled Trial of Perioperative Simvastatin Use in Elective Colorectal Surgery


Phase 3
18 Years
90 Years
Open (Enrolling)
Both
Intestinal Neoplasm, Perioperative Care

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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

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