Readmission Rate Clinical Trial
— PROFASTOfficial title:
Ensayo clínico Comparando Recuperación Postoperatoria Tras Protocolo FAST- TRACK Vs. Manejo Clásico en Cáncer de Ovario Avanzado
Verified date | September 2019 |
Source | Hospital Universitari Vall d'Hebron Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 110 |
Est. completion date | March 30, 2018 |
Est. primary completion date | March 30, 2018 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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). |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Universitari Vall d'Hebron | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Hospital Universitari Vall d'Hebron Research Institute |
Spain,
Delaney CP, Fazio VW, Senagore AJ, Robinson B, Halverson AL, Remzi FH. 'Fast track' postoperative management protocol for patients with high co-morbidity undergoing complex abdominal and pelvic colorectal surgery. Br J Surg. 2001 Nov;88(11):1533-8. — View Citation
Kehlet H. Multimodal approach to control postoperative pathophysiology and rehabilitation. Br J Anaesth. 1997 May;78(5):606-17. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | median length of stay | participants will be followed for the duration of hospital stay, an expected average of 2 weeks. | ||
Secondary | Number of readmissions related to postoperative complications. | 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. | 28 days after surgery | |
Secondary | Number of surgery related complications | 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. |
28 days after surgery. | |
Secondary | Cost per patient | 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. | 28 days after surgery |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
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