Venous Thromboembolism Clinical Trial
Official title:
PROSPECTIVE STUDY ON PREOPERATIVE VERSUS POSTOPERATIVE VENOUS THROMBOPROPHYLAXIS IN PATIENTS UNDERGOING MAJOR COLORECTAL SURGERY
Patients undergoing major colorectal surgery are at increased risk for VTE (deep venous
thrombosis) compared with patients undergoing other general surgical procedures (Bergqvist
et al. Dis. Col. Rectum. 2006; 49: 1620-1628.)
The reported incidence of symptomatic VTE after colorectal surgery is approximately 4%
(Monn, F. et al. JACS. 216; 2013: 395-401). However, the reported incidence of VTE after
colorectal surgery in prospectively followed patients managed with perioperative venous
thromboprophylaxis undergoing screening venography prior to hospital discharge ranges from 9
to 20% (Bergovist et al. NEJM 346; 2002: 975-980; McLeod et al. Ann. Surg. 233; 2000:
438-444; ENOXACAN Study group. Brit. J. Surg. 84; 1997: 1099-1103.
The Surgical Care Improvement Project (SCIP) and the American College of Chest Physician
(ACCP) guidelines recommend that venous thromboprophylaxis be initiated within 24 hours of
surgery. However, it is believed that deep venous thrombosis occurs during surgery, rather
than in the postoperative period, justifying preoperative initiation of venous
thromboprophylaxis. This practice is accompanied with a theoretically higher risk of
bleeding complications.
Currently there is no consensus on the precise timing of VTE prophylaxis after major
colorectal surgery, as demonstrated by the vague guidelines established by the ACCP and
SCIP. Current studies on VTE prophylaxis report preoperative initiation of VTE prophylaxis.
However, majority of surgeons at our institution begin heparin postoperatively given concern
for bleeding complications with preoperative dosing of heparin.
The purpose of this study is to prospectively evaluate the incidence of VTE and major
bleeding complications in patients undergoing major colorectal surgery who are treated with
preoperative or postoperative venous thromboprophylaxis and to help establish more stringent
guidelines on the optimal timing of VTE prophylaxis.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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