Perioperative Care Clinical Trial
— StatColOfficial title:
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.
Status | Completed |
Enrollment | 132 |
Est. completion date | September 2013 |
Est. primary completion date | September 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 90 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
New Zealand | Auckland City Hospital | Auckland | |
New Zealand | Manukau Surgical Centre, Middlemore Hospital | Auckland | |
New Zealand | North Shore Hospital | Auckland |
Lead Sponsor | Collaborator |
---|---|
University of Auckland, New Zealand | Auckland District Health Board, Counties Manukau Health, Waitemata District Health Board |
New Zealand,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Total complications | Complications pre-defined and graded by the Clavien-Dindo classification | Up to post-operative day 30 | No |
Secondary | Peritoneal Cytokines | Postoperative Day 1 | No | |
Secondary | Serum cytokines | Post-operative Day 1 | No | |
Secondary | Change in serum C-reactive protein (CRP) | Baseline and Postoperative Day 1, 2 and 3 | No | |
Secondary | Change in functional recovery | Baseline and Postoperative Day 1, 3, 7, 14, and 30 | No |
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