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

September 26, 2019 updated by: Hospital Universitari Vall d'Hebron Research Institute

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: FAST-TRACK Group
Patients in this group will be managed according to an specifically designed FAST-TRACK protocol which will include: Preoperatory nutritional management and coaching by surgeon, anesthetist, nutritionist and specifically trained nurse personnel, reduced preoperatory fasting, avoiding use of intraabdominal drainages, specific anesthetic management to reduce intraoperative stress, avoiding use of Nasogastric tube, avoiding the need for major opioid in postoperatory analgesia and use of an standardized postoperatory management protocol directed to obtain an early oral intake and mobilization with a the goal of normal diet and deambulation in the 3rd day after surgery.
Procedure: Fast-Track Protocol
Other Names:
  • Enhanced Recovery After Surgery
  • ERAS protocol
ACTIVE_COMPARATOR: Classical management group
Patients assigned to this group will receive the standard management preformed in our center until now. This management includes a preoperatory control exclusively by the surgeon and anesthetist, minimum of 8h fasting previous to surgery, loose use of intraabdominal drainage , systematic use of nasogastric tube whenever rectum resection or omentectomy is performed, Postoperative analgesia following standing Vall d'Hebron protocols for Moderate-severe postoperative pain, which include use of combined analgesia with non opioids drugs and major Opioids, and usual flexible, non standardized postoperatory management with mobilization and oral intake progression depending on perceived evolution by attending surgeon.
Procedure: Usual management
Other Names:
  • Classical management
  • Conventional care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
median length of stay
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
participants will be followed for the duration of hospital stay, an expected average of 2 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of readmissions related to postoperative complications.
Time Frame: 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.
28 days after surgery
Number of surgery related complications
Time Frame: 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.
28 days after surgery.
Cost per patient
Time Frame: 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.
28 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitari Vall d'Hebron Research Institute

Investigators

  • Study Director: Antonio Gil Moreno, MD, Hospital Vall d'Hebron
  • Principal Investigator: José Luis Sánchez Iglesias, MD, Hospital Vall d'Hebron

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 1, 2014

Primary Completion (ACTUAL)

March 30, 2018

Study Completion (ACTUAL)

March 30, 2018

Study Registration Dates

First Submitted

June 13, 2014

First Submitted That Met QC Criteria

June 20, 2014

First Posted (ESTIMATE)

June 24, 2014

Study Record Updates

Last Update Posted (ACTUAL)

September 30, 2019

Last Update Submitted That Met QC Criteria

September 26, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PR(AMI)136/2014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Median Length of Stay

Clinical Trials on Fast-Track Protocol

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Paraguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe