simvastatin
Drug40mg orally, given 3-7 days pre-op and continued till 14 days post-op
NCT Number: NCT00994903
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.
Looking for future studies?
Notify Me18 year–90 year
All sexes
Interventional
Phase 3
Auckland City Hospital, Auckland, New Zealand
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
40mg orally, given 3-7 days pre-op and continued till 14 days post-op
Placebo (Inert calcium lactate) tablets 3-7 days pre-op to 14 days post-op (as per experimental arm)
Time frame: Up to post-operative day 30
Complications pre-defined and graded by the Clavien-Dindo classification
Time frame: Postoperative Day 1
Time frame: Post-operative Day 1
Time frame: Baseline and Postoperative Day 1, 2 and 3
Time frame: Baseline and Postoperative Day 1, 3, 7, 14, and 30
University of Auckland, New Zealand
Other
Prospective, Double-Blinded, Multi-Centred, Randomised Controlled Trial of Perioperative Simvastatin Use in Elective Colorectal Surgery
Acronym: StatCol
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.
NCT01910974
Colorectal Neoplasms, Digestive System Diseases
Lyon, Auvergne-Rhône-Alpes, France
View Trial DetailsNCT06101628
Gel Nail, Healthy Individuals
Mersin, Turkey, Turkey (Türkiye)
View Trial DetailsNCT06106165
Bowel Cancer, Breast Cancer
Glasgow, Scotland, United Kingdom
View Trial DetailsNCT01269567
Colonic Diseases, Colorectal Neoplasms
Amiens, France
View Trial Details