Clinical trial NCT02172638: Postoperatory Recovery in Advanced Ovarian Cancer, Fast-Track Protocol vs. Classical Management
Official title: Ensayo clínico Comparando Recuperación Postoperatoria Tras Protocolo FAST- TRACK Vs. Manejo Clásico en Cáncer de Ovario Avanzado
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Median Length of Stay
Readmission Rate
Surgery Related Complications Rate
Cost Per Patient Rate
Keywords: Enhanced Recovery After Surgery
ERAS
Fast-Track
Ovarian cancer
Gynecologic surgery
Gynecology oncology
Median length of stay
Readmission rate
Surgery related complications
Cost
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
First posted: 2014-06-24
Enrollment: 110
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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).

Primary outcomes:
measure: median length of stay
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
Secondary outcomes:
measure: Number of readmissions related to postoperative complications.
timeFrame: 28 days after surgery
measure: Number of surgery related complications
timeFrame: 28 days after surgery.
measure: Cost per patient
timeFrame: 28 days after surgery
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
Study officials:
affiliation: Hospital Vall d'Hebron
name: Antonio Gil Moreno, MD
role: STUDY_DIRECTOR
affiliation: Hospital Vall d'Hebron
name: José Luis Sánchez Iglesias, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kehlet H. Multimodal approach to control postoperative pathophysiology and rehabilitation. Br J Anaesth. 1997 May;78(5):606-17. doi: 10.1093/bja/78.5.606.
citation: 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. doi: 10.1046/j.0007-1323.2001.01905.x.
citation: Chau JPC, Liu X, Lo SHS, Chien WT, Hui SK, Choi KC, Zhao J. Perioperative enhanced recovery programmes for women with gynaecological cancers. Cochrane Database Syst Rev. 2022 Mar 15;3(3):CD008239. doi: 10.1002/14651858.CD008239.pub5.
citation: Sanchez-Iglesias JL, Carbonell-Socias M, Perez-Benavente MA, Monreal Clua S, Manrique-Munoz S, Garcia Gorriz M, Burgos-Pelaez R, Segurola Gurrutxaga H, Pamies Serrano M, Pilar Gutierrez-Barcelo MD, Serrano-Castro S, Balcells-Farre MT, Perez-Barragan C, Scaillet-Houberechts A, Cossio-Gil Y, Gil-Moreno A. 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.