Adapted ERAS in Gynecologic Oncology Surgery

NCT ID: NCT04201626

Last Updated: 2020-06-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-01
• Study Completion Date: 2022-02-28

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

Conditions

Genital Neoplasm Malignant Female

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

ERAS

Group Type: EXPERIMENTAL

Adapted ERAS

Intervention Type: PROCEDURE

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.

Control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Chiang Mai University

OTHER

Sponsor Role: lead

Responsible Party

Kittipat Charoenkwan, MD

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kittipat Charoenkwan, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Chiang Mai University

Locations

Department of OB-GYN, Faculty of Medicine, Chiang Mai University

Chiang Mai, , Thailand

Site Status: RECRUITING

Countries

Thailand

Central Contacts

Kittipat Charoenkwan, MD, MSc

Role: CONTACT

kittipat.c@cmu.ac.th

+66-81-9920845

Facility Contacts

Kittipat Charoenkwan, MD, MSc

Role: primary

kittipat.c@cmu.ac.th

66-81-9920845

References

Chiewhatpong P, Charoenkwan K, Smithiseth K, Lapisatepun W, Lapisatepun P, Phimphilai M, Muangmool T, Cheewakriangkrai C, Suprasert P, Srisomboon J. Effectiveness of enhanced recovery after surgery protocol in open gynecologic oncology surgery: A randomized controlled trial. Int J Gynaecol Obstet. 2022 Nov;159(2):568-576. doi: 10.1002/ijgo.14211. Epub 2022 Apr 21.

Reference Type: DERIVED

PMID: 35396709 (View on PubMed)

Other Identifiers

ERAS_GYNONC 01

Identifier Type: -

Identifier Source: org_study_id