一项关于结直肠癌腹腔镜手术后静脉血栓栓塞预防 1 周与 4 周的随机研究。

A randomized study on 1-week versus 4-week prophylaxis for venous thromboembolism after laparoscopic surgery for colorectal cancer.

机构信息

*Internal and Cardiovascular Medicine-Stroke Unit, University of Perugia, Perugia, Italy †Oncology Surgery, University of Perugia, Perugia, Italy ‡General Surgery, S. Maria della Misericordia Hospital, Perugia, Italy §Unit of Angiology, University Hospital of Padua, Padua, Italy ¶General Surgery, Niguarda Hospital, Milan, Italy ‖General Surgery, S. Giovanni Battista Hospital, Foligno, Italy **Unit of Angiology, S. Giovanni Battista Hospital, Foligno, Italy ††Department of Surgical, Oncological and Gastroenterological Sciences, Section of Surgical Clinic I, University Hospital of Padua, Padua, Italy ‡‡General and Emergency Surgery, University of Perugia, Perugia, Italy.

出版信息

Ann Surg. 2014 Apr;259(4):665-9. doi: 10.1097/SLA.0000000000000340.

DOI:10.1097/SLA.0000000000000340

PMID:24253138

Abstract

OBJECTIVE

To compare the efficacy and safety of antithrombotic prophylaxis given for 1 week or 4 weeks in patients undergoing laparoscopic surgery for colorectal cancer.

BACKGROUND

Extending antithrombotic prophylaxis beyond 1 week reduces the incidence of venous thromboembolism (VTE) after open abdominal surgery for cancer.

METHODS

In consecutive patients who underwent laparoscopic surgery for colorectal cancer, complete compression ultrasonography of the lower limbs was performed after 8 ± 2 days of antithrombotic prophylaxis. Patients with no evidence of VTE were randomized to short (heparin withdrawal) or to extended (heparin continued for 3 additional weeks) prophylaxis. Complete compression ultrasonography was repeated at day 28 ± 2 after surgery by investigators blinded to treatment allocation. The primary outcome of the study was the composite of symptomatic and ultrasonography-detected VTE at day 28 ± 2 after surgery.

RESULTS

Overall, 301 patients were evaluated for inclusion in the study and 225 were randomized. VTE occurred in 11 of 113 patients randomized to short (9.7%) and in none of the 112 patients randomized to extended heparin prophylaxis (P = 0.001). The incidence of VTE at 3 months was 9.7% and 0.9% in patients randomized to short or to extended heparin prophylaxis, respectively (relative risk reduction: 91%, 95% confidence interval: 30%-99%; P = 0.005). The rate of bleeding was similar in the 2 treatment groups. Two patients died during the study period, 1 in each treatment group.

CONCLUSIONS

After laparoscopic surgery for colorectal cancer, extended antithrombotic prophylaxis is safe and reduces the risk for VTE as compared with 1-week prophylaxis (NCT01589146).

摘要

目的

比较在接受腹腔镜结直肠癌手术的患者中，应用 1 周或 4 周的抗血栓预防治疗的疗效和安全性。

背景

在接受开腹手术治疗癌症的患者中，延长抗血栓预防治疗时间超过 1 周可降低静脉血栓栓塞症（VTE）的发生率。

方法

在连续接受腹腔镜结直肠癌手术的患者中，在应用抗血栓预防治疗 8 ± 2 天后对下肢进行完全压缩超声检查。未发现 VTE 的患者随机分为短期（肝素停药）或延长（肝素继续应用 3 周）预防治疗组。由不了解治疗分配的研究者在手术后第 28 ± 2 天重复进行完全压缩超声检查。该研究的主要结局是手术后第 28 ± 2 天时出现症状和超声检查发现的 VTE 的复合事件。

结果

共有 301 例患者接受评估并被纳入研究，其中 225 例患者被随机分组。随机分为短期肝素组的 113 例患者中有 11 例（9.7%）和随机分为延长肝素组的 112 例患者中均无患者（P = 0.001）发生 VTE。随机分为短期或延长肝素组的患者在 3 个月时的 VTE 发生率分别为 9.7%和 0.9%（相对风险降低：91%，95%置信区间：30%-99%；P = 0.005）。两组的出血发生率相似。在研究期间有 2 例患者死亡，每组各 1 例。