Adherence and Compliance to ERAS in Gynecological Surgery
ERASGYNBS002
1 other identifier
observational
600
1 country
1
Brief Summary
The aim of the study is to investigate the association between early non-compliance to ERAS in postoperative day 2 (POD2) with the rate of postoperative complications.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 13, 2023
CompletedFirst Posted
Study publicly available on registry
February 22, 2023
CompletedStudy Start
First participant enrolled
May 30, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2025
CompletedJanuary 25, 2024
January 1, 2024
1.8 years
February 13, 2023
January 24, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Early non-compliance to ERAS
Association between the early non-compliance to ERAS with the rate of postoperative complications.
Postoperative day 2 (POD2)
Secondary Outcomes (1)
Early non-compliance to ERAS in tubo-ovarian cancer
Postoperative day 2 (POD2)
Study Arms (1)
Women affected by gynecological cancer.
Women affected by confirmed gynecological cancer treated with open access surgery and managed according to ERAS guidelines.
Interventions
Assessment of compliance to ERAS in postoperative day 2 (POD2) using five indicators based on ERAS items and association with postoperative complications up to 30 days after discharge.
Eligibility Criteria
Women affected by hystological confirmed gynecological cancer treated with open access surgery.
You may qualify if:
- histological diagnosis of primary or recurrent gynecological cancer (endometrial, uterine, tubo-ovarian and cervical cancer);
- perioperative management according to ERAS guidelines;
- age 18-75;
- open access surgery.
You may not qualify if:
- postoperative recovery in intensive care unit (planned or unplanned);
- Covid19 positive status known at the moment of surgery;
- minimally invasive access surgery or palliative surgery;
- prior pelvic radiotherapy;
- hyperthermic intraperitoneal chemotherapy;
- previous abdominal surgery (excluding appendectomy and primary surgery for gynecological malignancy);
- pelvic exenteration or lateral extended endopelvic resection (LEER).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Federico Ferrari
Brescia, BS, 25123, Italy
Related Publications (1)
Ferrari F, Bizzarri N, Fagotti A, Scambia G, Gozzini E, Soleymani Majd H, Rota M, Odicino F. Early non-compliance to ERAS in gynecological open surgery for malignancies, and post-operative complications: a multicenter, prospective, observational, cohort study. Int J Gynecol Cancer. 2025 Dec;35(12):101833. doi: 10.1136/ijgc-2024-005648. Epub 2025 Apr 17.
PMID: 39379327DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Federico Ferrari, MD, PhD
University of Brescia, Italy
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Consultant and Assistant Professor at Spedali Civili of Brescia and University of Brescia
Study Record Dates
First Submitted
February 13, 2023
First Posted
February 22, 2023
Study Start
May 30, 2023
Primary Completion
March 31, 2025
Study Completion
March 31, 2025
Last Updated
January 25, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will not share