Cost Per Patient Rate, Median Length of Stay, Readmission Rate, Surgery Related Complications Rate
Conditions
Keywords
Enhanced Recovery After Surgery, ERAS, Fast-Track, Ovarian cancer, Gynecologic surgery, Gynecology oncology, Median length of stay, Readmission rate, Surgery related complications, Cost
Brief summary
The concept of Fast-trak or Enhanced Recovery After Surgery ( ERAS) represents a new approach to the management of patients undergoing major surgery that re-examine traditional practices, replacing them if necessary with the best evidence based practices, creating a multimodal perioperative care pathway designed to achieve early recovery. In Colorectal Cancer Surgery , as well as in a number of other procedures it has been shown to reduce Hospitalization by more than 30% without increasing the rate complications or readmissions. However information on the results of Fast-track protocols when applied to Gynecological patients is sparse, being especially notorious the lack of data regarding the efficacy of Fast-track in the management of Advanced Gynecological cancer. Hypothesis: the application of a Fast-Track protocol in the management of patients with advanced Ovarian Cancer( Stage III, IV and relapses) may improve the postoperatory recovery of these patients allowing for an early discharge and significant cost reduction, when compared with de usual management, without increasing the number readmission or surgery related complications.
Interventions
PROCEDUREFast-Track Protocol
PROCEDUREUsual management
Sponsors
Hospital Universitari Vall d'Hebron Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years or more * Advanced ovarian cancer ( FIGO Stages III-IV, and relapses) tributary to laparotomic surgical management. * Patient accepts participation in the study and signs informed consent.
Exclusion criteria
* ASA IV * Active ischemic cardiac condition * Advanced cirrhosis ( Child-Pugh B -C). * Severe Psychiatric condition ( patient not capable of giving her informed consent properly, not capable or not willing to attend Follow-up visits).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| median length of stay | participants will be followed for the duration of hospital stay, an expected average of 2 weeks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of readmissions related to postoperative complications. | 28 days after surgery | To determine if there is an statistically significant difference in the readmission rate related to postoperative complications between the Fast-track and Classical management groups. |
| Number of surgery related complications | 28 days after surgery. | To determine if there is an statistically significant difference in surgery related complications rates between the Fast-track and Classical management groups. The number and severity will be recorded. as graded in the Clavien-Dindo Classification of Surgical Complications. |
| Cost per patient | 28 days after surgery | To determine if the application of a Fast-Track protocol in advanced ovarian cancer patients generates a significant cost per patient reduction when compared with classical management. The total cost for Hospitalization , readmissions and surgery related complications will be assessed according to the Public prices published in : SLT/383/2009, 21th January Diari Oficial de la Generalitat de Catalunya Núm. 5325 - 24.2.2009. |
Countries
Spain
Outcome results
None listed