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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00994903




Registration number
NCT00994903
Ethics application status
Date submitted
13/10/2009
Date registered
14/10/2009
Date last updated
2/12/2013

Titles & IDs
Public title
Simvastatin in Colorectal Surgery
Scientific title
Prospective, Double-Blinded, Multi-Centred, Randomised Controlled Trial of Perioperative Simvastatin Use in Elective Colorectal Surgery
Secondary ID [1] 0 0
StatCol
Universal Trial Number (UTN)
Trial acronym
StatCol
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intestinal Neoplasm 0 0
Perioperative Care 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Cancer 0 0 0 0
Bowel - Small bowel (duodenum and ileum)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Simvastatin
Treatment: Drugs - Placebo

Placebo comparator: Placebo - Placebo tablets (Inert calcium lactate)

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


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

Treatment: Drugs: Placebo
Placebo (Inert calcium lactate) tablets 3-7 days pre-op to 14 days post-op (as per experimental arm)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Total complications
Timepoint [1] 0 0
Up to post-operative day 30
Secondary outcome [1] 0 0
Peritoneal Cytokines
Timepoint [1] 0 0
Postoperative Day 1
Secondary outcome [2] 0 0
Serum cytokines
Timepoint [2] 0 0
Post-operative Day 1
Secondary outcome [3] 0 0
Change in serum C-reactive protein (CRP)
Timepoint [3] 0 0
Baseline and Postoperative Day 1, 2 and 3
Secondary outcome [4] 0 0
Change in functional recovery
Timepoint [4] 0 0
Baseline and Postoperative Day 1, 3, 7, 14, and 30

Eligibility
Key inclusion 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.
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2013
Sample size
Target
Accrual to date
Final
132
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Other
Name
University of Auckland, New Zealand
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Counties Manukau Health
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Government body
Name [2] 0 0
Waitemata District Health Board
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Government body
Name [3] 0 0
Auckland District Health Board
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT00994903
Trial related presentations / 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.
Public notes

Contacts
Principal investigator
Name 0 0
Andrew G Hill, MBChB MD FRACS
Address 0 0
University of Auckland, New Zealand
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00994903