Validation of an ERAS Protocol in Gynecological Surgery

Not Applicable

Completed

• Conditions: Hysterectomy; Surgery; Gynecologic Disease; Anesthesia; Gynecologic Cancer
• Interventions: Other: Changes in preoperative care; Other: Changes in intraoperative care; Other: Changes in postoperative care

• Registration Number: NCT03347409
• Lead Sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-14
• Study First Submitted: 2017-10-27
• Study First Submitted QC: 2017-11-15
• Study First Posted: 2017-11-20
• Primary Completion: 2019-07-14
• Study Completion: 2019-12-15
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-06
• Last Update Posted: 2020-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 166

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ERAS protocol	Changes in preoperative care	-
ERAS protocol	Changes in intraoperative care	-
ERAS protocol	Changes in postoperative care	-

Primary Outcome Measures

Name	Time	Method
Shorter Length Of Hospitalization (LOH)	Up to 4 weeks after surgery	Total amount of days spent in hospital

Secondary Outcome Measures

Name	Time	Method
Postoperative complications	Up to 9 weeks after surgery	Rate measurement
Presence/Absence of vomiting	At moment 0, 3, 6, 12 and 24 hours after surgery
Time to flatus	Up to 4 weeks after surgery	Hours elapsed to event
Anesthesiological complications	Up to 1 weeks after surgery	Rate measurement
Time to drink	Up to 4 weeks after surgery	Hours elapsed to event
Validated questionnaires	Administered 24 hours after surgery and up to 4 weeks after surgery	QoR15
Presence/Absence of nausea	At moment 0, 3, 6, 12 and 24 hours after surgery
Time to bowel movement	Up to 4 weeks after surgery	Hours elapsed to event
Assessment of postoperative pain	At moment 0, 3, 6, 12 and 24 hours after surgery	NRS scale (from 0 to 10, 0 is no pain, 10 is maximum pain)
Time to hunger	Up to 4 weeks after surgery	Hours elapsed to event
Time to eating	Up to 4 weeks after surgery	Hours elapsed to event
Time to walking	Up to 4 weeks after surgery	Hours elapsed to event
Compliance to ERAS protocol	Up to 4 weeks after surgery	Rate measurement

Trial Locations

Locations (1)

Federico Ferrari; 🇮🇹 Brescia, BS, Italy