A prospective cohort study protocol on sequential compression alone for the prevention of venous thromboembolism (VTE) in laparoscopic cholecystectomy.

BACKGROUND

Venous thromboembolism (VTE) is one of the leading causes of in-hospital mortality and is responsible for significant healthcare-related costs. However, a clear thromboprophylaxis protocol does not exist in surgery. The conventional method of thromboprophylaxis in surgery includes a combination of chemical and mechanical measures. Studies have shown that the administration of a chemical prophylaxis agent intra-operatively is associated with an increased incidence of surgical bleeding in surgeries such as laparoscopic cholecystectomy (LC). There are two common forms of mechanical prophylaxis: graduated compression stockings (GCSs) and sequential calf compression devices (SCCDs). Recent evidence has suggested several unwanted effects of GCSs, including skin breakage, the development of ulcers, and necrosis. There is a paucity of evidence investigating the use of SCCDs alone intra-operatively in VTE and surgical bleeding prevention.

MATERIALS AND

METHODS

This study reports on a multi-center, single-arm, prospective cohort study conducted across 11 hospitals, focusing on LC to standardize the operation. The aim is to recruit 5190 patients, as determined by power calculations, to investigate the incidence of clinical VTE 30 days after surgery. The hospitals involved already have policies in place to use SCCDs alone. All patients undergoing LC will be recruited prospectively, with a 30-day survey conducted to ascertain symptoms of VTE. Any reported symptoms will prompt appropriate radiological confirmation. The secondary outcome of bleeding or other complications arising from VTE prophylaxis will also be collected.

RESULTS

Ethical approval was obtained for this study. Results will be submitted for publication in a peer-reviewed journal and disseminated through participating hospitals.

CONCLUSION

This study aims to provide information on the incidence of VTE in the LC population following the use of SCCDs only at the time of surgery and to compare it to historical controls of combined SCCDs and GCSs. The benefits include economic, safety, and environmental improvements.