Postoperative Outcomes Within an Enhanced Recovery after surgery protocol in gastric surgery for cancer (POWER.4): Study protocol for a prospective, multicentre, observational cohort study

Abstract

Background and objective: Enhanced recovery pathways or ERAS have been applied in gastric cancer surgery extrapolated from colorectal surgery. The objective of the study is to assess postoperative complications 30 days after gastric surgery for cancer, with any level of compliance with the ERAS protocol. The secondary objectives are to assess 30-day mortality, the relationship between adherence to the ERAS protocol and complications, the impact of each of the items of the protocol on postoperative complications and hospital stay, and to describe the impact of complications on length of hospital stay.

Materials and methods: Multicenter, observational, prospective study including all consecutive patients undergoing scheduled gastric cancer surgery, over a period of 3 months, with a 30-day follow-up at participating centers, with any level of compliance with the protocol.

Results: The approval of the Comité Autonómico de Ética de la Investigación de Aragón has been obtained (C.P. - C.I. PI19 / 106, 27 th March 2019). POWER.4 was registered at www.clinicaltrials.gov on March 7, 2019 (NCT03865810).

Conclusions: The data as a whole will be published in peer-reviewed journals. The data will not be made public by identifying each participating center. It is expected that the results of this study will identify potential areas for improvement in which more targeted research is needed.

Keywords: Complicaciones postoperatorias; Cumplimiento de protocolo; Estancia hospitalaria; Gastrectomy; Gastrectomía; Length of stay; Postoperative complications; Protocol compliance; Recovery of function; Recuperación de la función.