Validation of an ERAS Protocol in Gynecological Surgery (ERASGYNBS001)

Validation of an ERAS Protocol in Gynecological Surgery: an Italian Randomized Controlled Trial

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

Study Overview

• Status: Completed
• Conditions: Gynecologic Cancer; Surgery; Anesthesia; Hysterectomy; Gynecologic Disease
• Intervention / Treatment: Other: Changes in preoperative care; Other: Changes in intraoperative care; Other: Changes in postoperative care

• Study Type: Interventional
• Enrollment (Actual): 166
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • BS
    • Brescia, BS, Italy, 25123
      • Federico Ferrari

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard Perioperative (SP) care
Experimental: ERAS protocol	Other: Changes in preoperative care; Optimization of relevant medical uncontrolled situations, avoid fasting, avoid bowel preparation, avoid premedications, nutritional assessment, stop smoking, stop alcohol and appropriate counselling; Other: Changes in intraoperative care; Blended anesthesia is mostly carried out using Total Intra Venous Anesthesia (TIVA) with loco regional analgesia, in particular Thoracic Epidural Anesthesia (TEA) in open surgery and spinal morphine or Transversus Abdominis Plane (TAP) block or quadratus lumborum block for laparoscopic surgical approach, associated to NSAIDs or acetaminophen; control of deep neuromuscular blocking with Train-of-four (TOF) stimulation avoiding residual paralysis. Multimodal prevention of PONV (according to preoperative assessment of Apfel Score) with a combination of multiple antiemetic drugs.; Other: Changes in postoperative care; Postoperative pain control is obtained with opioid sparing strategies, in order to avoid Post Operative Ileus (POI) and PONV. According to the type of surgery TEA, TAP block , quadratus lumborum block or IT morphine is preferred. Patient is proposed to start drinking clear fluid 4 hours after surgery and to start eating the evening of the surgery, with the introduction of a normal free diet within 24 hours after surgery. It is proposed to chew gum three times daily for at least 15 minutes and eventually to use laxatives to promote a faster bowel function. Early mobilization is started from the evening of surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Shorter Length Of Hospitalization (LOH)	Total amount of days spent in hospital	Up to 4 weeks after surgery

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Publications and helpful links

General Publications

• Chau 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:CD008239. doi: 10.1002/14651858.CD008239.pub5. Review.
• Ferrari 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2017
• Primary Completion (Actual): July 14, 2019
• Study Completion (Actual): December 15, 2019

Study Registration Dates

• First Submitted: October 27, 2017
• First Submitted That Met QC Criteria: November 15, 2017
• First Posted (Actual): November 20, 2017

Study Record Updates

• Last Update Posted (Actual): February 7, 2020
• Last Update Submitted That Met QC Criteria: February 6, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: ERAS, Fast-track surgery, gynecology
• Other Study ID Numbers: NP 2722

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No