NCT02172638: PROFAST

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

Completed NA Last updated 30 September 2019

What this trial tests

NA trial testing Fast-Track Protocol in Median Length of Stay in 110 participants. Completed in 30 March 2018.

Timeline

1 June 2014

Primary endpoint
30 March 2018

30 March 2018

Quick facts

Lead sponsor	Hospital Universitari Vall d'Hebron Research Institute
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	110
Start date	1 June 2014
Primary completion	30 March 2018
Estimated completion	30 March 2018
Sites	1 location across Spain

Drugs / interventions tested

• Fast-Track Protocol
• Usual management

Conditions studied

• Median Length of Stay — all drugs for Median Length of Stay →
• Readmission Rate — all drugs for Readmission Rate →
• Surgery Related Complications Rate — all drugs for Surgery Related Complications Rate →
• Cost Per Patient Rate — all drugs for Cost Per Patient Rate →

Sponsor

Hospital Universitari Vall d'Hebron Research Institute

Who can join

18 and older, female only, with Median Length of Stay or Readmission Rate. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. PROFAST: A randomised trial implementing enhanced recovery after surgery for highcomplexity advanced ovarian cancer surgery.
   Sánchez-Iglesias JL, Carbonell-Socias M, Pérez-Benavente MA, Monreal Clua S, et al · · 2020 · cited 52× · PMID 32688208 · DOI 10.1016/j.ejca.2020.06.011
2. Perioperative enhanced recovery programmes for women with gynaecological cancers.
   Chau JPC, Liu X, Lo SHS, Chien WT, et al · · 2022 · cited 13× · PMID 35289396 · DOI 10.1002/14651858.cd008239.pub5