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CompletedNCT00994903StatColUpdated Dec 2, 2013

Simvastatin in Colorectal Surgery

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

Phase
Phase 3
Study type
Interventional
Enrollment
132
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Intestinal Neoplasm
  • Perioperative Care

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Keywords

  • Statin
  • Colon
  • Colorectal
  • Intestinal Neoplasms
  • ERAS
  • Perioperative Care
03

In context

Intestinal Neoplasms

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
132 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Placebo tablets (Inert calcium lactate)

    Drug: Placebo

  • Experimental
    Simvastatin

    40mg of Simvastatin given 3-7 days pre-op and continued till 14 days post-op

    Drug: Simvastatin

Interventions

  • DrugSimvastatin

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

  • DrugPlacebo

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

06

What researchers measure

Primary outcomes

  1. Total complications

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

    Time frame: Up to post-operative day 30

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

07

Study locations

3 sites
  • Auckland City Hospital
    Auckland, New Zealand
  • Manukau Surgical Centre, Middlemore Hospital
    Auckland, New Zealand
  • North Shore Hospital
    Auckland, New Zealand
08

References and documents

Publications

  • Singh PP, Lemanu DP, Soop M, Bissett IP, Harrison J, Hill AG. Perioperative Simvastatin Therapy in Major Colorectal Surgery: A Prospective, Double-Blind Randomized Controlled Trial. J Am Coll Surg. 2016 Aug;223(2):308-320.e1. doi: 10.1016/j.jamcollsurg.2016.04.004. Epub 2016 Apr 13. PubMed 27086089 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 2, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00994903
Lead sponsor
University of Auckland, New Zealand
Collaborators
Counties Manukau Health, Waitemata District Health Board, Auckland District Health Board
Responsible party
Andrew G Hill (Professor Andrew Hill, University of Auckland, New Zealand) — Principal investigator
First posted
Oct 14, 2009
Start date
Oct 2011
Primary completion
Sep 2013
Completion
Sep 2013
Last update
Dec 2, 2013

Study contacts

Andrew G Hill, MBChB MD FRACS
principal investigator · University of Auckland, New Zealand

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.

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