A Phase 3 interventional study of Simvastatin and Placebo in Intestinal Neoplasm and Perioperative Care, sponsored by University of Auckland, New Zealand. Completed at 3 sites in New Zealand. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2013-12-02.
Sponsored by University of Auckland, New Zealand · Phase 3, Interventional, and Treatment
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.
177 studies on the registry are indexed under Intestinal Neoplasms; 20 are open to participants now.
This study's enrollment of 132 is above the median of 60 across 114 interventional studies indexed under Intestinal Neoplasms.
Browse Intestinal Neoplasms studies →University of Auckland, New Zealand is the lead sponsor of 57 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
Placebo tablets (Inert calcium lactate)
Drug: Placebo
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
Placebo (Inert calcium lactate) tablets 3-7 days pre-op to 14 days post-op (as per experimental arm)
Total complications
Complications pre-defined and graded by the Clavien-Dindo classification
Time frame: Up to post-operative day 30
Peritoneal Cytokines
Time frame: Postoperative Day 1
Serum cytokines
Time frame: Post-operative Day 1
Change in serum C-reactive protein (CRP)
Time frame: Baseline and Postoperative Day 1, 2 and 3
Change in functional recovery
Time frame: Baseline and Postoperative Day 1, 3, 7, 14, and 30
This study is completed, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Auckland, New Zealand