Title

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

    Phase 3
  • Study Type

    Interventional
  • Status

    Completed No Results Posted
  • Intervention/Treatment

    simvastatin ...
  • Study Participants

    132
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.
Study Started
Oct 31
2011
Primary Completion
Sep 30
2013
Study Completion
Sep 30
2013
Last Update
Dec 02
2013
Estimate

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 Placebo Comparator

Placebo tablets (Inert calcium lactate)

Simvastatin Experimental

40mg of Simvastatin given 3-7 days pre-op and continued till 14 days post-op

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.
No Results Posted