Simvastatin in Colorectal Surgery

Phase 3

Completed

• Conditions: Intestinal Neoplasm; Perioperative Care
• Interventions: Drug: Placebo; Drug: Simvastatin

• Registration Number: NCT00994903
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-10-13
• Study First Submitted QC: 2009-10-13
• Study First Posted: 2009-10-14
• Study Start: 2011-10
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-27
• Last Update Posted: 2013-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo tablets (Inert calcium lactate)
Simvastatin	Simvastatin	40mg of Simvastatin given 3-7 days pre-op and continued till 14 days post-op

Primary Outcome Measures

Name	Time	Method
Total complications	Up to post-operative day 30	Complications pre-defined and graded by the Clavien-Dindo classification

Secondary Outcome Measures

Name	Time	Method
Peritoneal Cytokines	Postoperative Day 1
Serum cytokines	Post-operative Day 1
Change in serum C-reactive protein (CRP)	Baseline and Postoperative Day 1, 2 and 3
Change in functional recovery	Baseline and Postoperative Day 1, 3, 7, 14, and 30

Trial Locations

Locations (3)

Auckland City Hospital; 🇳🇿 Auckland, New Zealand

Manukau Surgical Centre, Middlemore Hospital; 🇳🇿 Auckland, New Zealand

North Shore Hospital; 🇳🇿 Auckland, New Zealand