Adapted ERAS in Gynecologic Oncology Surgery

• Sponsor: Chiang Mai University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04201626
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 20
• Patients Per Site Per Month: 10

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Genital Neoplasm Malignant Female	Procedure: Adapted ERAS	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: Effectiveness of Adapted Enhanced Recovery After Surgery Protocol in Open Gynecologic Oncology Surgery: A Randomized Controlled Trial
• Actual Study Start Date: Jun 1, 2020
• Anticipated Primary Completion Date: Dec 1, 2021
• Anticipated Study Completion Date: Feb 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ERAS	Procedure: Adapted ERAS; Each woman in the intervention group will attend a preoperative counseling session with nurse and doctors. In addition to the standard preoperative counseling, explaining the purpose, process, and the importance of ERAS protocol compliance will be added to the session. Preoperative nutrition and laboratory assessment will be done according to adapted ERAS protocol on that same visit. During admission, the intervention group participants are provided with care according to adapted ERAS protocol including no bowel preparation, no extended fasting before surgery, balanced intravenous crystalloid, thromboprophylaxis, multimodal pain control reducing opioid usage, multimodal anti-emetics medications, stepping diet up to regular diet within 24 hours, chewing gum for post-operative ileus prevention, early removal of Foley's catheter, and promote early ambulation using care checklist plan.
No Intervention: Control

Outcome Measures

Primary Outcome Measures

1. Length of hospital stay [Through hospital discharge, an average of 5 days]

   Length of hospital stay after surgery

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of OB-GYN, Faculty of Medicine, Chiang Mai University	Chiang Mai		Thailand	50200

Sponsors and Collaborators

• Chiang Mai University

Investigators

• Principal Investigator: Kittipat Charoenkwan, MD, MSc, Chiang Mai University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kittipat Charoenkwan, MD, Associate Professor, Chiang Mai University
• ClinicalTrials.gov Identifier: NCT04201626
• Other Study ID Numbers: ERAS_GYNONC 01
• First Posted: Dec 17, 2019
• Last Update Posted: Jun 29, 2020
• Last Verified: Jun 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Neoplasms

Study Results

No Results Posted as of Jun 29, 2020