Postoperatory Recovery in Advanced Ovarian Cancer, Fast-Track Protocol vs. Classical Management

Readmission Rate Clinical Trial

— PROFAST  

Official title:

Ensayo clínico Comparando Recuperación Postoperatoria Tras Protocolo FAST- TRACK Vs. Manejo Clásico en Cáncer de Ovario Avanzado

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02172638
• Other study ID #: PR(AMI)136/2014
• Status: Completed
• Phase: N/A
• Start date: June 1, 2014
• Est. completion date: March 30, 2018

Study information

• Verified date: September 2019
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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).

Related Conditions & MeSH terms

• Cost Per Patient Rate
• Median Length of Stay
• Readmission Rate
• Surgery Related Complications Rate

Intervention

Procedure:
• Fast-Track Protocol

• Usual management

Locations

Country	Name	City	State
Spain	Hospital Universitari Vall d'Hebron	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitari Vall d'Hebron Research Institute

Country where clinical trial is conducted

Spain, 

References & Publications (2)

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

Outcome

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

External Links

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