Genital Neoplasm Malignant Female Clinical Trial
Official title:
Effectiveness of Adapted Enhanced Recovery After Surgery Protocol in Open Gynecologic Oncology Surgery: A Randomized Controlled Trial
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
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT04202874 -
A Trial Comparing Surgeon-administered TAP Block With Placebo After Midline Laparotomy in Gynecologic Oncology
|
Phase 3 |