Clinical trial · Observational
Adherence and Compliance to ERAS in Gynecological Surgery
Adherence and Compliance to ERAS in Gynecological Surgery as Predictor of Postoperative Complications
NCT05738902CI-TRIAL-00073280ERASGYNBS002unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervix Cancer | — | UNRESOLVED | — |
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
| ERAS | — | UNRESOLVED | — |
| Gynecologic Cancer | Malignant Female Reproductive System Neoplasm | ALIAS | 0.90 |
| Gynecologic Neoplasm | Female Reproductive System Neoplasm | ALIAS | 0.90 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Post Operative Pain | — | UNRESOLVED | — |
| Uterine Cancer | Malignant Uterine Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Assessment of compliance to ERAS. | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Women affected by gynecological cancer.
- description
- Women affected by confirmed gynecological cancer treated with open access surgery and managed according to ERAS guidelines.
- interventionNames
- Other: Assessment of compliance to ERAS.
Primary outcomes (1)
- measure
- Early non-compliance to ERAS
- timeFrame
- Postoperative day 2 (POD2)
- description
- Association between the early non-compliance to ERAS with the rate of postoperative complications.
Secondary outcomes (1)
- measure
- Early non-compliance to ERAS in tubo-ovarian cancer
- timeFrame
- Postoperative day 2 (POD2)
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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).
References
Publications (1)
- DERIVEDFerrari 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 39379327