Enhanced Recovery Protocols in Gynecologic Oncology

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age25-85
SponsorNational and Kapodistrian University of Athens

About this trial

Enhanced Recovery After Surgery (ERAS) are developed to provide a systematic structure for managing postsurgical patients.These protocols promote evidenced-based practices and implement a multidisciplinary effort to maintain normal physiology in the perioperative period and aid in earlier recovery. The present study aims to investigate the feasibility of and compliance to a structured ERAS protocol among Gynecological Oncological Centers in Greece as well as to compare the outcomes among patients that fullfilled the minimum number of necessary criteria, compared to those that were enrolled in ERAS protocols but did not meet the sufficient necessary criteria.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial population

In this study, patients that will be operated for gynecological cancer in the collaborating centers described in the Contacts and Locations section will be enrolled.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • ERAS group

    Combination product

    This group will include patients that achieved a compliance rate that exceeded 80% of the required predetermined criteria of ERAS protocols.

  • Control group

    Combination product

    This group will include patients that do not follow the predetermined criteria of ERAS protocols

Treatment groups

600 Participants
are divided into 2 treatment groups
Group A: Fulfilled ERAS criteria group1 intervention
Group B: Control group1 intervention

Trial outcomes

Primary outcomes

1

Duration of hospitalization

From date of hospitalization until the date of discharge or date of death from any cause, whichever came first, assessed up to 2 months.

Time frame
Up to 30 days postoperatively
2

Perioperative infections

Number of participants with postoperative infections (including surgical site, pulmonary and urinary tract infections)

Time frame
Postoperatively (30 days)

Secondary outcomes

1

Postoperative quality of life

Documentation of quality of life using the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C40) and the Functional Assessment of Cancer Therapy - General (FACT-G) questionnaires. The EORTC-QLQ C30 involves 30 questions that are rated from 1 (no impact on quality of life) to 4 (debilitating symptoms). The FACT-G assesses physical, family, emotional and functional wellbeing through 27 questions that are scaled from 0 (no impact) to 4 (very much).

Time frame
Postoperatively (30 days)
2

Postoperative morbidity (other than infectious) using the Clavien-Dindo classification

Major events such as pulmonary embolism,accuse myocardial infarction,etc

Time frame
30 days
3

Interval to adjuvant therapy

The interval between surgical treatment and adjuvant therapy (radiation and/or chemotherapytreatment) will be documented

Time frame
Up to 100 days
4

Recurrence rates

Recurrent disease will be monitored through 3 year of follow up

Time frame
3 years follow-up

Other outcomes

Sponsors and contacts

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National and Kapodistrian University of Athens

Lead sponsor

University of Thessaly

Collaborator

Aristotle University Of Thessaloniki

Collaborator

Metaxa Hospital

Collaborator

Saint Savvas Anticancer Hospital

Collaborator