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Simvastatin in Colorectal Surgery

NCT ID: NCT00994903

Last Updated: 2013-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2013-09-30

Brief Summary

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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

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Conditions

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Intestinal Neoplasm Perioperative Care

Keywords

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Statin Colon Colorectal Intestinal Neoplasms ERAS Perioperative Care

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Placebo tablets (Inert calcium lactate)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Simvastatin

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

Group Type EXPERIMENTAL

Simvastatin

Intervention Type DRUG

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

Interventions

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Simvastatin

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Counties Manukau Health

OTHER

Sponsor Role collaborator

Waitemata District Health Board

OTHER_GOV

Sponsor Role collaborator

Auckland District Health Board

OTHER_GOV

Sponsor Role collaborator

University of Auckland, New Zealand

OTHER

Sponsor Role lead

Responsible Party

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Andrew G Hill

Professor Andrew Hill

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrew G Hill, MBChB MD FRACS

Role: PRINCIPAL_INVESTIGATOR

University of Auckland, New Zealand

Locations

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Auckland City Hospital

Auckland, , New Zealand

Site Status

Manukau Surgical Centre, Middlemore Hospital

Auckland, , New Zealand

Site Status

North Shore Hospital

Auckland, , New Zealand

Site Status

Countries

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New Zealand

References

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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.

Reference Type DERIVED
PMID: 27086089 (View on PubMed)

Other Identifiers

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StatCol

Identifier Type: -

Identifier Source: org_study_id