Simvastatin in Colorectal Surgery (StatCol)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00994903
Recruitment Status : Completed
First Posted : October 14, 2009
Last Update Posted : December 2, 2013
Counties Manukau Health
Waitemata District Health Board
Auckland District Health Board
Information provided by (Responsible Party):
Andrew G Hill, University of Auckland, New Zealand

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Intestinal Neoplasm Perioperative Care Drug: Simvastatin Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prospective, Double-Blinded, Multi-Centred, Randomised Controlled Trial of Perioperative Simvastatin Use in Elective Colorectal Surgery
Study Start Date : October 2011
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Simvastatin

Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo tablets (Inert calcium lactate)
Drug: Placebo
Placebo (Inert calcium lactate) tablets 3-7 days pre-op to 14 days post-op (as per experimental arm)

Experimental: Simvastatin
40mg of Simvastatin given 3-7 days pre-op and continued till 14 days post-op
Drug: Simvastatin
40mg orally, given 3-7 days pre-op and continued till 14 days post-op

Primary Outcome Measures :
  1. Total complications [ Time Frame: Up to post-operative day 30 ]
    Complications pre-defined and graded by the Clavien-Dindo classification

Secondary Outcome Measures :
  1. Peritoneal Cytokines [ Time Frame: Postoperative Day 1 ]
  2. Serum cytokines [ Time Frame: Post-operative Day 1 ]
  3. Change in serum C-reactive protein (CRP) [ Time Frame: Baseline and Postoperative Day 1, 2 and 3 ]
  4. Change in functional recovery [ Time Frame: Baseline and Postoperative Day 1, 3, 7, 14, and 30 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00994903

New Zealand
Auckland City Hospital
Auckland, New Zealand
Manukau Surgical Centre, Middlemore Hospital
Auckland, New Zealand
North Shore Hospital
Auckland, New Zealand
Sponsors and Collaborators
University of Auckland, New Zealand
Counties Manukau Health
Waitemata District Health Board
Auckland District Health Board
Principal Investigator: Andrew G Hill, MBChB MD FRACS University of Auckland, New Zealand

Responsible Party: Andrew G Hill, Professor Andrew Hill, University of Auckland, New Zealand Identifier: NCT00994903     History of Changes
Other Study ID Numbers: StatCol
First Posted: October 14, 2009    Key Record Dates
Last Update Posted: December 2, 2013
Last Verified: November 2013

Keywords provided by Andrew G Hill, University of Auckland, New Zealand:
Intestinal Neoplasms
Perioperative Care

Additional relevant MeSH terms:
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors