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Simvastatin in Colorectal Surgery (StatCol)

This study has been completed.
Sponsor:
Collaborators:
Counties Manukau District Health Board
Waitemata District Health Board
Auckland District Health Board
Information provided by (Responsible Party):
Andrew G Hill, University of Auckland, New Zealand
ClinicalTrials.gov Identifier:
NCT00994903
First received: October 13, 2009
Last updated: November 27, 2013
Last verified: November 2013

October 13, 2009
November 27, 2013
October 2011
September 2013   (final data collection date for primary outcome measure)
Total complications [ Time Frame: Up to post-operative day 30 ] [ Designated as safety issue: No ]
Complications pre-defined and graded by the Clavien-Dindo classification
Surgical Recovery [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00994903 on ClinicalTrials.gov Archive Site
  • Peritoneal Cytokines [ Time Frame: Postoperative Day 1 ] [ Designated as safety issue: No ]
  • Serum cytokines [ Time Frame: Post-operative Day 1 ] [ Designated as safety issue: No ]
  • Change in serum C-reactive protein (CRP) [ Time Frame: Baseline and Postoperative Day 1, 2 and 3 ] [ Designated as safety issue: No ]
  • Change in functional recovery [ Time Frame: Baseline and Postoperative Day 1, 3, 7, 14, and 30 ] [ Designated as safety issue: No ]
Peritoneal Cytokines [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Simvastatin in Colorectal Surgery
Prospective, Double-Blinded, Multi-Centred, Randomised Controlled Trial of Perioperative Simvastatin Use in Elective Colorectal Surgery

Statins (HMG-CoA reductase inhibitors) are a widely used class of cholesterol-lowering drugs that have an established role in the medical management of cardiovascular disease. Their benefits have also been shown in the surgical setting with decreased cardiovascular complications and lower perioperative mortality following cardiac and vascular surgery. There is now considerable evidence showing statins have useful pleiotropic properties that extend beyond cholesterol lowering, including anti-inflammatory, anti-oxidant, immunomodulatory and fibrinolytic effects. Growing evidence suggests these effects may be useful in attenuating the proinflammatory and metabolic stress response to surgery and the benefit of statins may extend to other surgical settings such as abdominal surgery.

Laboratory studies demonstrate the surgically-relevant benefits of statins and show they decrease peritoneal inflammation, reduce the severity of intestinal ischaemia-reperfusion injury, improve survival in models of abdominal sepsis, decrease the formation of postoperative intraperitoneal adhesions and improve the healing of colonic anastomoses. Retrospective clinical studies show statins improve outcomes in sepsis, reduce the postoperative systemic inflammatory response syndrome (SIRS) and are associated with decreased rates of surgical wound infections and postoperative respiratory complications following various non-cardiac general surgical procedures. However, no prospective studies have specifically evaluated the perioperative use of statins in abdominal surgery. Using colorectal surgery as a model for major abdominal surgery, the investigators will conduct a randomised controlled trial evaluating the effect of perioperative statin use on postoperative morbidity, local and systemic inflammatory response, and functional recovery after surgery.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Intestinal Neoplasm
  • Perioperative Care
  • Drug: Simvastatin
    40mg orally, given 3-7 days pre-op and continued till 14 days post-op
  • Drug: Placebo
    Placebo (Inert calcium lactate) tablets 3-7 days pre-op to 14 days post-op (as per experimental arm)
  • Placebo Comparator: Placebo
    Placebo tablets (Inert calcium lactate)
    Intervention: Drug: Placebo
  • Experimental: Simvastatin
    40mg of Simvastatin given 3-7 days pre-op and continued till 14 days post-op
    Intervention: Drug: Simvastatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
132
September 2013
September 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
New Zealand
 
NCT00994903
StatCol
No
Andrew G Hill, University of Auckland, New Zealand
University of Auckland, New Zealand
  • Counties Manukau District Health Board
  • Waitemata District Health Board
  • Auckland District Health Board
Principal Investigator: Andrew G Hill, MBChB MD FRACS University of Auckland, New Zealand
University of Auckland, New Zealand
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP