Adapted ERAS in Gynecologic Oncology Surgery

Not Applicable

• Conditions: Genital Neoplasm Malignant Female
• Interventions: Procedure: Adapted ERAS

• Registration Number: NCT04201626
• Lead Sponsor: Chiang Mai University

Brief Summary

Background: In recent decades, the new concept of Enhanced Recovery After Surgery (ERAS) program has been well accepted in the fields of gynecologic surgery. Many studies have shown the effectiveness of ERAS protocol in reducing hospital's length of stay, patient's morbidity, and rate of postoperative complications while cutting back on health care cost. Thus, standard guidelines such as ACOG has strongly recommended ERAS protocol implementation into each institution. However, institutions have self-limitations on adapting the standard ERAS pathway published from ERAS society due to the demand in resources. The concept of partial implementation of ERAS protocol has been raised and was mentioned in guidelines that ERAS implementation should be individualized to each institution. Nevertheless, the effectiveness of adapted ERAS protocol itself has not been well researched.

Objectives: To examine the effect of partial implementation of ERAS protocol adapted to our institution on patient's recovery (based on hospital length of stay, pain score, time to flatulence, postoperative complications, and re-visits) compared to standard routine care in women diagnosed with gynecologic malignancy (cervix, endometrium, and ovary) undergoing elective open surgery.

Design: A randomized controlled trial in gynecologic cancers (cervix, endometrium, and ovary) women, age 18-75 years, undergoing elective open gynecologic oncology surgery at Faculty of Medicine, Chiang Mai University hospital. The participants will be randomly assigned into one of two study groups: intervention (adapted ERAS protocol) and control (standard routine care).

For the intervention group, each woman will be brought through the adapted ERAS protocol step by step starting from preoperative counseling and preparation, intraoperative management, and postoperative management standard according to the adapted ERAS protocol. For the control group, each woman will be cared for using routine standard care.

The primary outcome is length of hospital stay.

1.3 Proposed duration 24 Months

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-12-03
• Study First Submitted QC: 2019-12-14
• Study First Posted: 2019-12-17
• Status Verified: 2020-06
• Study Start: 2020-06-01
• Last Update Submitted: 2020-06-25
• Last Update Posted: 2020-06-29
• Primary Completion: 2021-12
• Study Completion: 2022-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

• 18 - 75 years old
• Diagnosed with gynecologic malignancy of cervix, endometrium, or ovary
• Elective laparotomy surgery

Exclusion Criteria

• Intraoperative accidental injury to urinary or GI organs
• Retain endotracheal intubation after surgery
• Peritoneal drainage for monitoring of bleeding/infection
• Unable to follow oral instructions
• Severe neuromuscular disease
• Preoperative hyperalimentation
• Neoadjuvant chemotherapy within 3 weeks prior to the procedure
• Previous abdominal/pelvic radiation
• Bowel obstruction
• Emergency operation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ERAS	Adapted ERAS	-

Primary Outcome Measures

Name	Time	Method
Length of hospital stay	Through hospital discharge, an average of 5 days	Length of hospital stay after surgery

Trial Locations

Locations (1)

Department of OB-GYN, Faculty of Medicine, Chiang Mai University; 🇹🇭 Chiang Mai, Thailand