Validation of an ERAS Protocol in Gynecological Surgery (ERASGYNBS001)

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Status: Completed

Conditions: Surgery; Hysterectomy; Gynecologic Cancer; Gynecologic Disease; Anesthesia

Treatments: Other: Changes in preoperative care; Other: Changes in postoperative care; Other: Changes in intraoperative care

Study type: Interventional

Funder types: Other

Identifiers

NCT03347409

NP 2722

Details and patient eligibility

About

Validation of ERAS interventional measures in elective gynecological surgery, for benign either malignant pathology.

Enrollment: 166 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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166 participants in 2 patient groups

Standard Perioperative (SP) care

No Intervention group

ERAS protocol

Experimental group

Treatment:

Other: Changes in intraoperative care

Other: Changes in preoperative care

Other: Changes in postoperative care