Clinical trial · Interventional
Adapted ERAS in Gynecologic Oncology Surgery
Effectiveness of Adapted Enhanced Recovery After Surgery Protocol in Open Gynecologic Oncology Surgery: A Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Genital Neoplasm Malignant Female | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adapted ERAS | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ERAS
- interventionNames
- Procedure: Adapted ERAS
- type
- NO_INTERVENTION
- label
- Control
Primary outcomes (1)
- measure
- Length of hospital stay
- timeFrame
- Through hospital discharge, an average of 5 days
- description
- Length of hospital stay after surgery
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDChiewhatpong 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. PMID 35396709