PROFAST: A randomised trial implementing enhanced recovery after surgery for highcomplexity advanced ovarian cancer surgery

Eur J Cancer. 2020 Sep;136:149-158. doi: 10.1016/j.ejca.2020.06.011. Epub 2020 Jul 18.


Background: Enhanced recovery after surgery (ERAS) programs include multiple perioperative elements designed to achieve early recovery after surgery and a shorter length of stay (LOS) in hospital. The PROFAST trial aimed to expand the evidence base for implementing ERAS in advanced gynaecologic oncology surgery.

Methods: This prospective, interventional randomised clinical trial enrolled women undergoing surgery for either suspected or diagnosed advanced ovarian cancer, at a reference hospital in gynaecologic oncology in Barcelona (Spain) and who were treated after either an ERAS protocol or conventional management (CM) protocol. All enrolled women who underwent cytoreductive surgery were included in the primary analysis. The primary outcome was reduction in LOS, and secondary outcomes were incidence and type of intraoperative and postoperative complications, rate of readmission and mortality within a 30-d follow-up period. This trial is registered at, number NCT02172638.

Findings: From June 2014 to March 2018, 110 women were recruited, of which eleven were excluded. The ERAS group comprised 50 patients, and the CM group, 49 patients. Both groups were comparable with respect to baseline characteristics and complexity of the cytoreductive surgery, with an overall medium/high Aletti surgical complexity score of 7.4. Overall compliance to the ERAS protocol was 92%. As compared with the patients in the CM group, patients in the ERAS group had a decreased median of LOS of two days (7 versus 9 days; p = 0.0099) and a decreased rate of readmission (6% versus 20%, p = 0.0334). No further significant differences were detected with respect to incidence of intraoperative or postoperative complications, severe (Clavien-Dindo grade IIIB-IV) complications, Comprehensive Complication Index, reoperation during primary stay, or mortality.

Interpretation: Patients with advanced ovarian cancer in the ERAS program had a decreased LOS and decreased rate of readmission as compared with those in CM, with no increased morbidity or mortality. This study provides important evidence for the benefits of ERAS management even for gynaecologic surgeries of medium/high complexity and suggests that ERAS should be a standard practice for cytoreductive surgeries for peritoneal carcinomatosis.

Keywords: Advanced ovarian cancer; Complete cytoreductive surgery; Enhanced recovery after surgery (ERAS); High-complexity surgery; Length of stay; Peritoneal carcinomatosis; Recurrent ovarian cancer.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adenocarcinoma / epidemiology
  • Adenocarcinoma / pathology
  • Adenocarcinoma / surgery*
  • Adult
  • Aged
  • Cytoreduction Surgical Procedures / adverse effects
  • Cytoreduction Surgical Procedures / methods
  • Cytoreduction Surgical Procedures / statistics & numerical data
  • Disease Progression
  • Enhanced Recovery After Surgery*
  • Feasibility Studies
  • Female
  • Gynecologic Surgical Procedures / adverse effects
  • Gynecologic Surgical Procedures / methods*
  • Gynecologic Surgical Procedures / statistics & numerical data
  • Humans
  • Implementation Science
  • Length of Stay / statistics & numerical data
  • Middle Aged
  • Morbidity
  • Mortality
  • Ovarian Neoplasms / epidemiology
  • Ovarian Neoplasms / pathology
  • Ovarian Neoplasms / surgery*
  • Patient Readmission / statistics & numerical data
  • Perioperative Care / methods
  • Perioperative Care / statistics & numerical data
  • Peritoneal Neoplasms / epidemiology
  • Peritoneal Neoplasms / secondary
  • Peritoneal Neoplasms / surgery
  • Postoperative Complications / epidemiology
  • Postoperative Complications / etiology
  • Reoperation / statistics & numerical data
  • Treatment Outcome

Associated data