Investigating adherence to ERAS in gynecological surgery
Adherence and Compliance to ERAS in Gynecological Surgery as Predictor of Postoperative Complications
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia · NCT05738902
This study looks at how following certain recovery guidelines after gynecological cancer surgery affects complications and recovery for women in the days right after their operation.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Brescia, BS) |
| Trial ID | NCT05738902 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the relationship between early non-compliance to Enhanced Recovery After Surgery (ERAS) protocols on postoperative day 2 and the incidence of postoperative complications in women undergoing open surgery for gynecological cancer. The study will assess compliance using five specific indicators derived from ERAS guidelines. Participants will be monitored for pain control and recovery metrics to determine the impact of adherence on surgical outcomes. The study is multicenter and prospective, focusing on a critical postoperative timeframe.
Who should consider this trial
Good fit: Ideal candidates include women aged 18-75 with a histological diagnosis of primary or recurrent gynecological cancer who are undergoing open surgery.
Not a fit: Patients who have undergone minimally invasive surgery, are in intensive care, or have other specified exclusions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve postoperative recovery and reduce complications for women undergoing gynecological cancer surgery.
How similar studies have performed: Previous studies have shown that adherence to ERAS protocols can significantly improve recovery outcomes, suggesting that this approach is supported by existing evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: * 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. Exclusion criteria: * 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).
Where this trial is running
Brescia, BS
- Federico Ferrari — Brescia, BS, Italy (RECRUITING)
Study contacts
- Principal investigator: Federico Ferrari, MD, PhD — University of Brescia, Italy
- Study coordinator: Federico Ferrari, MD, PhD
- Email: federico.ferrari@unibs.it
- Phone: 00390303995341
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: ERAS, Gynecologic Cancer, Post Operative Pain, Ovarian Cancer, Endometrial Cancer, Cervix Cancer, Uterine Cancer, Gynecologic Neoplasm