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Simvastatin in Colonic Surgery

2014-08-27 03:18:40 | BioPortfolio

Summary

Statins are the most commonly prescribed class of drugs and inhibit the 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase enzyme lowering serum cholesterol and thus reducing cardiovascular risk. New evidence, however, suggests that Statins may also have uses beyond lipid lowering. Statins have shown anti-inflammatory and anti-oxidant properties, they prolong endothelial Nitric Oxide Synthase to act as vasodilators and have systemic influence at the cellular level. Statins have also been shown to decrease peritoneal inflammation and decrease levels of pro-inflammatory cytokines which the investigators have previously shown are correlated to recovery after surgery. Retrospective and Laboratory studies investigating Statins have reported improved outcomes in sepsis and Acute Pancreatitis as well as decreased rates of surgical wound infections and post-operative respiratory complications. They have also been shown to reduce intestinal ischaemia and reperfusion injury decreasing the risk of bacterial translocation and reducing the impact of the Systemic Inflammatory Response Syndrome (SIRS). No prospective studies have evaluated the perioperative use of Simvastatin in Colorectal Surgery or evaluated the impact of Statin use on systemic and local peritoneal cytokine release. The investigators will conduct a case-control study and then a randomized controlled trial (RCT) comparing Simvastatin to placebo to determine whether there are differences in both cytokine response and recovery. No such studies have been previously conducted.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Intestinal Neoplasm

Intervention

Simvastatin, Placebo

Location

Manukau Surgical Centre, Middlemore Hospital
Auckland
New Zealand

Status

Not yet recruiting

Source

University of Auckland, New Zealand

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:18:40-0400

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Medical and Biotech [MESH] Definitions

A pharmaceutical preparation of ezetimibe and simvastatin that is used in the treatment of HYPERCHOLESTEROLEMIA and HYPERLIPIDEMIAS.

Abnormal growths of tissue that follow a previous neoplasm but are not metastases of the latter. The second neoplasm may have the same or different histological type and can occur in the same or different organs as the previous neoplasm but in all cases arises from an independent oncogenic event. The development of the second neoplasm may or may not be related to the treatment for the previous neoplasm since genetic risk or predisposing factors may actually be the cause.

A condition caused by the lack of intestinal PERISTALSIS or INTESTINAL MOTILITY without any mechanical obstruction. This interference of the flow of INTESTINAL CONTENTS often leads to INTESTINAL OBSTRUCTION. Ileus may be classified into postoperative, inflammatory, metabolic, neurogenic, and drug-induced.

Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.

Dilatation of the intestinal lymphatic system usually caused by an obstruction in the intestinal wall. It may be congenital or acquired and is characterized by DIARRHEA; HYPOPROTEINEMIA; peripheral and/or abdominal EDEMA; and PROTEIN-LOSING ENTEROPATHIES.

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