Enhanced Recovery Protocols in Gynecologic Oncology

Recruiting

• Conditions: ERAS; Gynecologic Cancer; Perioperative Complication; Postoperative Pain; Quality of Life; Infections

• Registration Number: NCT06655506
• Lead Sponsor: National and Kapodistrian University of Athens

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2024-03-27
• Status Verified: 2024-10
• Study Start: 2024-10-20
• Study First Submitted QC: 2024-10-22
• Last Update Submitted: 2024-10-22
• Study First Posted: 2024-10-23
• Last Update Posted: 2024-10-23
• Primary Completion: 2026-03-31
• Study Completion: 2026-07-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 600

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Duration of hospitalization	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.
Perioperative infections	Postoperatively (30 days)	Number of participants with postoperative infections (including surgical site, pulmonary and urinary tract infections)

Secondary Outcome Measures

Name	Time	Method
Postoperative quality of life	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).
Postoperative morbidity (other than infectious) using the Clavien-Dindo classification	30 days	Major events such as pulmonary embolism,accuse myocardial infarction,etc
Interval to adjuvant therapy	Up to 100 days	The interval between surgical treatment and adjuvant therapy (radiation and/or chemotherapytreatment) will be documented
Recurrence rates	3 years follow-up	Recurrent disease will be monitored through 3 year of follow up
Overall survival	3 years follow-up	Overall survival of the patients will be measured through 3 year of follow up

Trial Locations

Locations (8)

Agios Savvas Anticancer Hospital; 🇬🇷 Athens, Attica, Greece

First department of Obstetrics and Gynecology, National and Kapodistrian University of Athens; 🇬🇷 Athens, Attica, Greece

Metaxa Anticancer Hospital; 🇬🇷 Athens, Piraeus, Greece

First department of Obstetrics and Gynecology; 🇬🇷 Athens, Greece

University of Thessaly; 🇬🇷 Larissa, Greece

Aristotle University of Thessaloniki, Second department of Obstetrics and Gynecology; 🇬🇷 Thessaloniki, Greece

Aristotle University of Thessaloniki, Third department of Obstetrics and Gynecology; 🇬🇷 Thessaloniki, Greece

Aristotle University of Thesalloniki, Papageorgiou Hospiral; 🇬🇷 Thessaloniki, Greece