Skip to main content
OpenTrials
Completed

NCT Number: NCT00994903

Simvastatin in 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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Auckland City Hospital, Auckland, New Zealand

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

simvastatin

Drug

40mg orally, given 3-7 days pre-op and continued till 14 days post-op

Placebo

Drug

Placebo (Inert calcium lactate) tablets 3-7 days pre-op to 14 days post-op (as per experimental arm)

Primary outcomes

  1. Total complications

    Time frame: Up to post-operative day 30

    Complications pre-defined and graded by the Clavien-Dindo classification

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Auckland, New Zealand

Other

Collaborators

  • Auckland District Health Board
  • Counties Manukau Health
  • Waitemata District Health Board

Registry information

Official study title

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

Acronym: StatCol

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Oct 14, 2009
Registry last updated
Dec 2, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.