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NCT Number: NCT06655506

Enhanced Recovery Protocols in Gynecologic Oncology

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.

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Key information

Conditions

ERAS Gynecologic Cancer Infections Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Perioperative Complication Postoperative Complications Postoperative Pain Quality of Life Signs and Symptoms

Age range

25 year–85 year

Sex eligibility

Female

Study type

Observational

Primary location

First department of Obstetrics and Gynecology, Athens, Greece

Loading trial locations.

About this study

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. ERAS protocols briefly include pre-admission education, pre-operative nutritional care, specific recommendations for pre-operative medications, a standardized anesthetic protocol, perioperative fluid management, multimodal analgesia (MMA), early mobilization, and early removal of urinary catheters.

ERGO study 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. Patients will be registered into the trial before surgery. Quality assurance program will be in place for both patients that will fulfill the ERAS criteria as well as for those that will not fulfill them.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

patients with gynaecological cancer and an ECOG performance status <4, ASA score <4.

Exclusion criteria

patients with metastatic cancer of non-gynaecological origin patients that are not able to follow ERAS protocol due to medical reasons patients with severe debilitating comorbidities (ECOG status 4, ASA score 4-5)

Treatment and study plan

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

Primary outcomes

  1. Duration of hospitalization

    Time frame: Up to 30 days postoperatively

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

  2. Perioperative infections

    Time frame: Postoperatively (30 days)

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

Secondary outcomes

  1. Postoperative quality of life

    Time frame: Postoperatively (30 days)

    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).

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

    Time frame: 30 days

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

  3. Interval to adjuvant therapy

    Time frame: Up to 100 days

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

  4. Recurrence rates

    Time frame: 3 years follow-up

    Recurrent disease will be monitored through 3 year of follow up

  5. Overall survival

    Time frame: 3 years follow-up

    Overall survival of the patients will be measured through 3 year of follow up

Study contacts

Contact information is provided by the study sponsor or research team.

Nikolaos Thomakos, MD, PhD

CONTACT

[email protected]

+302132162291

Vasilios Pergialiotis, MD, PhD, MSc

CONTACT

[email protected]

+302132162291

Sponsors and collaborators

Lead sponsor

National and Kapodistrian University of Athens

Other

Collaborators

  • Aristotle University Of Thessaloniki
  • Metaxa Hospital
  • Saint Savvas Anticancer Hospital
  • University of Thessaly

Registry information

Official study title

Enhanced Recovery Protocols in Gynecological Cancer Patients: a Feasibility Study

Acronym: ERGO

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 23, 2024
Registry last updated
Oct 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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