Clinical trial · Interventional
Validation of an ERAS Protocol in Gynecological Surgery
Validation of an ERAS Protocol in Gynecological Surgery: an Italian Randomized Controlled Trial
NCT03347409CI-TRIAL-00043268ERASGYNBS001completedN/AClinicalTrials.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)
Validation of ERAS interventional measures in elective gynecological surgery, for benign either malignant pathology.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anesthesia | — | UNRESOLVED | — |
| Gynecologic Cancer | Malignant Female Reproductive System Neoplasm | ALIAS | 0.90 |
| Gynecologic Disease | — | UNRESOLVED | — |
| Hysterectomy | — | UNRESOLVED | — |
| Surgery | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Changes in intraoperative care | Other | — | UNRESOLVED |
| Changes in postoperative care | Other | — | UNRESOLVED |
| Changes in preoperative care | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Standard Perioperative (SP) care
- type
- EXPERIMENTAL
- label
- ERAS protocol
- interventionNames
- Other: Changes in preoperative care
- Other: Changes in intraoperative care
- Other: Changes in postoperative care
Primary outcomes (1)
- measure
- Shorter Length Of Hospitalization (LOH)
- timeFrame
- Up to 4 weeks after surgery
- description
- Total amount of days spent in hospital
Secondary outcomes (13)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Age \>18 and \<75 years old * Patients candidated for elective gynecological surgery for benign pathology * Patients with diagnosis of gynecological neoplasm and candidated for elective gynecological surgery * Signed consent form * Karnofsky Performance Status \> 70 Exclusion Criteria: * ASA score \> 3 * Contraindication to loco-regional anaesthesia * Patients with ileus or subocclusive condition prior surgery * Coagulation disorders * Organ failure or severe disfunction (heart, renal, pulmonary, hepatic) * Uncontrolled hypertension (\>180/95) * Alcohol or drug abuser (current or previous) * Unability to self-care (PFS \< 70) * Comorbidity-Polypharmacy Score \> 22 * Psychiatric condition or language barriers * Planned Intensive Care Recovery
References
Publications (2)
- DERIVEDChau JPC, Liu X, Lo SHS, Chien WT, Hui SK, Choi KC, Zhao J. Perioperative enhanced recovery programmes for women with gynaecological cancers. Cochrane Database Syst Rev. 2022 Mar 15;3(3):CD008239. doi: 10.1002/14651858.CD008239.pub5. PMID 35289396
- DERIVEDFerrari F, Forte S, Sbalzer N, Zizioli V, Mauri M, Maggi C, Sartori E, Odicino F. Validation of an enhanced recovery after surgery protocol in gynecologic surgery: an Italian randomized study. Am J Obstet Gynecol. 2020 Oct;223(4):543.e1-543.e14. doi: 10.1016/j.ajog.2020.07.003. Epub 2020 Jul 8. PMID 32652064