Clinical trial NCT04201626: Adapted ERAS in Gynecologic Oncology Surgery
Official title: Effectiveness of Adapted Enhanced Recovery After Surgery Protocol in Open Gynecologic Oncology Surgery: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Genital Neoplasm Malignant Female
Lead sponsor: Chiang Mai University
Sponsor class: OTHER
First posted: 2019-12-17
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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


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

Primary outcomes:
measure: Length of hospital stay
timeFrame: Through hospital discharge, an average of 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Chiang Mai
country: Thailand
facility: Department of OB-GYN, Faculty of Medicine, Chiang Mai University
Study officials:
affiliation: Chiang Mai University
name: Kittipat Charoenkwan, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.