Ovarian cancer affects more than 3,000 women each year in Spain. Many of them must undergo surgery, which can be very invasive and even require the resection of different organs located in the abdomen before treatment with chemotherapy. The PROFAST clinical trial ("Clinical trial comparing postoperative recovery after FAST-TRACK protocol vs classical management in advanced gynecological cancer"), led by the Gynecological Oncology and Pathology of the Lower Genital Tract Unit of the Vall d'Hebron University Hospital and the Biomedical Research group in Gynecology at the Vall d'Hebron Research Institute (VHIR) has shown that a new protocol improves the recovery of patients operated on with advanced ovarian cancer. This is the first randomized study of this protocol in advanced ovarian cancer worldwide.
The enhanced recovery after surgery (ERAS) protocol implemented by the Vall d'Hebron team is based on a set of strategies that are applied during the preoperative, intraoperative and postoperative periods with the aim of facilitate the recovery of ovarian cancer patients, reduce hospital admission time, minimize complications after surgery and readmissions, as well as improve comfort. The importance of the results obtained and the impact on the patients have allowed the study to be published in the European Journal of Cancer.
"The Vall d'Hebron Gynecology Service is the first and only center to date accredited by the Spanish multimodal rehabilitation group (GERM) as a center of excellence in intensified recovery", highlights Dr. José Luís Sánchez, physician of the Gynecological Oncology Unit of the Vall d'Hebron University Hospital, researcher of the Biomedical Research in Gynecology group at VHIR and first author of the work. The study also had the participation of the Anesthesia, Resuscitation and Pain Management Department, the Nitrition Support Unit and the Directorate of Information Systems of Vall d'Hebron.
Enhanced recovery protocol for ovarian cancer
The ERAS enhanced recovery protocol includes a set of actions all aimed at improving the comfort of patients and their clinical evolution. Among the main differences with respect to the surgeries that had been performed up to now, it stands out that an intense preoperative bowel preparation is no longer necessary but that an enema the previous night is enough; the patients do not arrive fasting for the surgical intervention, but two hours before they ingest 200 ml of maltodextrin (a sugary drink); and they can eat again 6 hours after the surgery.
"It is also important, in relation to analgesics, to avoid the use of morphine, since it can have more side effects in patients", explains Dr. Susana Manrique, head of the Anesthesia, Resuscitation and Pain Management Department at Hospital Vall d'Hebron and researcher in the Fetal Maternal Medicine group at VHIR. On the other hand, the ERAS protocol also recommends assessing their nutritional status before surgery, removing drains as soon as possible, and encouraging patients to sit up and start walking after surgery.
To validate its usefulness in ovarian cancer, the Vall d'Hebron study included 100 women with ovarian cancer who underwent surgery. In half of them, the usual protocol was followed and, in the rest, the ERAS protocol was implemented.
Among the results of the study, it stands out that the group of patients treated with the protocol recommendations was discharged, on average, two days before the rest of the patients (7 days of admission in the case of patients in the ERAS group, 9 days in control patients). Furthermore, patients in the ERAS group had a much lower readmission rate (6% of ERAS patients required a new admission to hospital, while this was the case in 20% of the control group). "We have shown that this protocol improves the evolution and comfort of patients without increasing postoperative complications", says Dr. Antonio Gil Moreno, head of the Gynecology Service of the Vall d'Hebron University Hospital and head of the Biomedical Research group in Gynecology at VHIR.
The reduction in hospitalization time, the intensification of care, as well as the better evolution of patients treated with the ERAS protocol contributes to economic savings for the center and the health system, which can reach up to € 1,146 per patient.
In 2014, the ERAS protocol was already implemented in Vall d'Hebron for patients with ovarian cancer. However, until now there was no scientific evidence to demonstrate its usefulness for this type of surgery, but it was based on the recommendations for patients with colorectal surgery. "This methodology requires a great effort on the part of a multidisciplinary team at the hospital, which includes gynecology, oncology, psychiatry, anesthesiology, nursing, nutrition and rehabilitation teams", explains Mª del Pilar Gutiérrez, Nursing Supervisor of the Gynecology plant of Vall d'Hebron. "For this reason, it is very important to have objective evidence-based data such as those obtained with the PROFAST trial that reinforces the efficacy of this protocol".
ERAS is now available for all gynecological and breast surgery. "At present, with the support of the Hospital Directorate, we are working to adapt it to the approach of any type of surgery performed in Vall d'Hebron", concludes Dr. Asun Pérez, head of Section of the Gynecological Oncology and Pathology of the Lower Genital Tract Unit at Vall d'Hebron Hospital and researcher at the Biomedical Research group in Gynecology at the VHIR.