Enhanced Recovery After Surgery (ERAS) in Gynecological Surgery (ERASGS-01) (ERAS)

A Prospective, Randomized Trial Comparing ERAS and Conventional Protocol for Perioperative Care of Patients After Gynecological Surgery

Enhanced recovery programs are composed of preoperative, intraoperative and postoperative strategies combined to form a multi-modal pathway. ERAS requires a multidisciplinary team of anesthetists, surgeons and nurses for successful implementation and realization of its advantages.The aim of this study is to compare outcomes of conventional perioperative care with those of an enhanced recovery after surgery (ERAS) perioperative care plan in women undergoing surgery for gynecologic cancer or suspected gynecologic disease.

Study Overview

• Status: Completed
• Conditions: Gynecologic Cancer; Gynecologic Disease
• Intervention / Treatment: Procedure: ERAS protocol

Detailed Description

The study design is a two-arm, randomized, controlled trial. The control arm will consist of standard conventional perioperative care. The intervention arm will consist of a protocol-driven ERAS program. The investigators believe that this information will be very useful because although there is a national interest in creating ERAS protocols for gynecology, there currently is very little published on the subject. Investigators hypothesize that those patients randomized to the ERAS protocol will have shorter lengths of hospital stay and complications, without increasing readmission rates. The investigators would like to publish the investigators' results and protocol as a resource for other institutions to adopt.

• Study Type: Interventional
• Enrollment (Actual): 540
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Beihua Kong, MD.PhD.; Phone Number: +8618560081888; Email: kongbeihua@sdu.edu.cn
• Study Contact Backup: Name: Jin Peng, MD.PhD.; Phone Number: +86185600818205; Email: jin_peng@outlook.com

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China
      • Qilu Hospital of Shandong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age >18 and <70 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

Exclusion Criteria:

• 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)
• 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: Conventional Perioperative (SP) care
Experimental: ERAS protocol; preoperative / intraoperative/ postoperative management	Procedure: ERAS protocol; preoperative management Optimization of relevant medical uncontrolled situations, avoid fasting, avoid bowel preparation, avoid premedications, nutritional assessment, stop smoking, stop alcohol and appropriate counselling intraoperative management Multimodal prevention of prophylaxis against nausea and vomiting (PONV) (according to preoperative assessment of Apfel Score) with a combination of multiple antiemetic drugs. postoperative management Postoperative pain control is obtained with opioid sparing strategies, in order to avoid Post Operative Ileus (POI) and PONV. It is proposed to chew gum three times daily , fluid therapy, early mobilization, early feeding within 2 hours postoperative for at least 15 minutes and eventually to promote a faster bowel function.

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
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 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
Assessment of postoperative pain	Measurement of pain score post-operation will be obtained using clinical data gathered by the care team providing routine clinical care, and asking routine pain score questions. The scale used is the standard 1-10 pain scale, with 1 being no pain or very mild discomfort, and 10 being very severe pain.	At moment 24 hours after surgery
Presence/Absence of nausea	Treatment for postoperative nausea	At moment 0, 3, 6, 12 and 24 hours after surgery
Presence/Absence of vomiting	Treatment for postoperative vomiting	At moment 0, 3, 6, 12 and 24 hours after surgery
Foley catheter removal	Time to Foley catheter removal postoperative	From 1 to 14days post surgery
Postoperative complications	Rate measurement	Up to 2 weeks after surgery
Time to adjuvant treatment	Time participant receives adjuvant treatment, if needed (chemotherapy or radiation)	60 days
Readmission rates	Readmissions to the hospital	Up to 21 days post surgery

Collaborators and Investigators

• Sponsor: Shandong University
• Investigators: Principal Investigator: Beihua Kong, MD.PhD., Qilu Hospital of Shandong University

Publications and helpful links

General Publications

• Peng J, Dong R, Jiao J, Liu M, Zhang X, Bu H, Dong P, Zhao S, Xing N, Feng S, Yang X, Kong B. Enhanced Recovery After Surgery Impact on the Systemic Inflammatory Response of Patients Following Gynecological Oncology Surgery: A Prospective Randomized Study. Cancer Manag Res. 2021 Jun 1;13:4383-4392. doi: 10.2147/CMAR.S294718. eCollection 2021.

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2018
• Primary Completion (Actual): June 30, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: August 10, 2018
• First Submitted That Met QC Criteria: August 10, 2018
• First Posted (Actual): August 14, 2018

Study Record Updates

• Last Update Posted (Actual): April 25, 2023
• Last Update Submitted That Met QC Criteria: April 22, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: preoperative / intraoperative/ postoperative management
• Other Study ID Numbers: ERASGS-01

Drug and device information, study documents

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