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Clinical Trials/NCT04201626
NCT04201626
Unknown
Not Applicable

Effectiveness of Adapted Enhanced Recovery After Surgery Protocol in Open Gynecologic Oncology Surgery: A Randomized Controlled Trial

Chiang Mai University1 site in 1 country200 target enrollmentJune 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Genital Neoplasm Malignant Female
Sponsor
Chiang Mai University
Enrollment
200
Locations
1
Primary Endpoint
Length of hospital stay
Last Updated
5 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
June 1, 2020
End Date
February 2022
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kittipat Charoenkwan, MD

Associate Professor

Chiang Mai University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Length of hospital stay

Time Frame: Through hospital discharge, an average of 5 days

Length of hospital stay after surgery

Study Sites (1)

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