Simvastatin in Colorectal Surgery (StatCol)

This study has been completed.
Sponsor:
Collaborators:
Counties Manukau District Health Board
Waitemata District Health Board
Auckland District Health Board
Information provided by (Responsible Party):
Andrew G Hill, University of Auckland, New Zealand
ClinicalTrials.gov Identifier:
NCT00994903
First received: October 13, 2009
Last updated: November 27, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Intestinal Neoplasm
Perioperative Care
Drug: Simvastatin
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prospective, Double-Blinded, Multi-Centred, Randomised Controlled Trial of Perioperative Simvastatin Use in Elective Colorectal Surgery

Resource links provided by NLM:


Further study details as provided by University of Auckland, New Zealand:

Primary Outcome Measures:
  • Total complications [ Time Frame: Up to post-operative day 30 ] [ Designated as safety issue: No ]
    Complications pre-defined and graded by the Clavien-Dindo classification


Secondary Outcome Measures:
  • Peritoneal Cytokines [ Time Frame: Postoperative Day 1 ] [ Designated as safety issue: No ]
  • Serum cytokines [ Time Frame: Post-operative Day 1 ] [ Designated as safety issue: No ]
  • Change in serum C-reactive protein (CRP) [ Time Frame: Baseline and Postoperative Day 1, 2 and 3 ] [ Designated as safety issue: No ]
  • Change in functional recovery [ Time Frame: Baseline and Postoperative Day 1, 3, 7, 14, and 30 ] [ Designated as safety issue: No ]

Enrollment: 132
Study Start Date: October 2011
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo tablets (Inert calcium lactate)
Drug: Placebo
Placebo (Inert calcium lactate) tablets 3-7 days pre-op to 14 days post-op (as per experimental arm)
Experimental: Simvastatin
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

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00994903

Locations
New Zealand
Manukau Surgical Centre, Middlemore Hospital
Auckland, New Zealand
North Shore Hospital
Auckland, New Zealand
Auckland City Hospital
Auckland, New Zealand
Sponsors and Collaborators
University of Auckland, New Zealand
Counties Manukau District Health Board
Waitemata District Health Board
Auckland District Health Board
Investigators
Principal Investigator: Andrew G Hill, MBChB MD FRACS University of Auckland, New Zealand
  More Information

No publications provided

Responsible Party: Andrew G Hill, Professor Andrew Hill, University of Auckland, New Zealand
ClinicalTrials.gov Identifier: NCT00994903     History of Changes
Other Study ID Numbers: StatCol
Study First Received: October 13, 2009
Last Updated: November 27, 2013
Health Authority: New Zealand: Health and Disability Ethics Committees

Keywords provided by University of Auckland, New Zealand:
Statin
Colon
Colorectal
Intestinal Neoplasms
ERAS
Perioperative Care

Additional relevant MeSH terms:
Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Simvastatin
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on April 23, 2014