Status:
COMPLETED
Validation of an ERAS Protocol in Gynecological Surgery
Lead Sponsor:
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Conditions:
Surgery
Hysterectomy
Eligibility:
FEMALE
18-75 years
Phase:
NA
Brief Summary
Validation of ERAS interventional measures in elective gynecological surgery, for benign either malignant pathology.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 14 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2019
Estimated Enrollment :
166 Patients enrolled
Trial Details
Trial ID
NCT03347409
Start Date
June 14 2017
End Date
December 15 2019
Last Update
February 7 2020
Active Locations (1)
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1
Federico Ferrari
Brescia, BS, Italy, 25123