Timing of Chemical Thromboprophylaxis

and Deep Thrombosis in Major Colorectal

Surgery
A Randomized Clinical Trial

Karen N. Zaghiyan, MD, et al. for the Cedars-Sinai DVT Study Group
Annals of Surgery, September 2016

Presented by: Garrett Friedman and Jordan Smith

Date: 09/19/2016

Study Objectives
To identify the optimal timing of perioperative
chemical thromboprophylaxis
and
incidence of occult preoperative DVT in patients
undergoing major colorectal surgery.

Background
There is limited data on optimal timing of CTP in major colorectal surgery.
Existing data based on orthopaedic surgery suggests that VTE risk may be
lowered with preoperative CTP at the expense of bleeding complications,
whereas in a study of hysterectomy there were increased bleeding
complications without a significant improvement in VTE rate.
Current protocol at Hillel-Yaffe: Single preoperative 1 mg/kg SC
enoxaparin night before surgery OR 5,000 IU heparin morning of surgery SC.
Postoperative enoxaparin 24 hours after surgery depending on blood test
values.

Methods: Study Design and Population

Sample Size Calculation

A sample size of 199 participants per study arm for a total of 398
participants total was needed to have 80% power to identify a 10%
difference in the incidence of VTE between the study arms when the
expected incidence of VTE in patients treated with post-operative
CTP was 20% and a 2-sided alpha risk was 0.05. To account for dropouts we
anticipated enrolment of 410 patients.

Methods: Study Design and Population

Patient Enrollment

Methods: Treatment and Evaluation

Preoperative CTP: Subcutaneous heparin (5000 units) in the preoperative
holding area before surgery. Subcutaneous heparin (5000 units) every 8 hours
was reinitiated starting 8 hours after surgery and continued until hospital
discharge.
Postoperative CTP: Subcutaneous heparin (5000 units) every 8 hours was
started postoperatively within 24 hours after surgery and continued until
hospital discharge.
All patients: Sequential compression devices before surgery and continued
postoperatively. Encouraged to ambulate 3 times daily beginning POD1

Results: Optimal CTP Timing

VTE Prevention

There was no significant difference in early postoperative

VTE between patients randomized to preoperative (n = 3,
1.6%) or postoperative CTP (n=5, 2.6%)
Preoperative and postoperative CTP are equally safe in
protecting against VTE.

Results: Optimal CTP Timing

VTE Prevention

What can we conclude from this data?

Results: Optimal CTP Timing

Overall Patient Outcomes

No evidence that patient outcome/rate of complication is changed

Results: Optimal CTP Timing

Bleeding Complications

Results: Optimal CTP Timing

Bleeding Complications

Results: Occult DVT Screening

Epidemiology

Results: Occult DVT Screening

Epidemiology

Conclusion: Implications/Future Research

Concerning CTP Timing:
With a lower than expected incidence of perioperative VTE and equal safety of
preoperative or postoperative CTP in patients undergoing major colorectal
surgery, clinicians can choose either perioperative CTP regimen with
confidence
Do we agree with this statement?
Concerning OP-DVT Screening:
We recommend a screening lower extremity venous duplex to identify occult
preoperative DVT before major colorectal surgery, particularly in older
patients and those with medical comorbidity.
Do we agree with this statement?