ERAS and Postoperative Recovery in Gynecologic Patients: A QoR-15 Study

NCT06878079 | Not Yet Recruiting DMC

• 1 other identifier: 202407159RINB
• Study Type: observational
• Target: 130
• Locations: 0 countries
• Sites: N/A

Brief Summary

The Quality of Recovery-15 (QoR-15) questionnaire is a widely used Patient-Reported Outcome Measure (PROM) for evaluating postoperative recovery, including pain, physical function, and emotional well-being. Enhanced Recovery After Surgery (ERAS) is a multidisciplinary care model designed to optimize perioperative management through standardized protocols. For gynecological surgery, ERAS emphasizes preoperative education, early interventions (e.g., smoking cessation, anemia management, nutrition optimization), intraoperative strategies (e.g., fluid balance, nausea prevention, temperature control), and postoperative care (e.g., early mobilization, pain control, ileus prevention). However, while ERAS is gaining acceptance, its effectiveness can vary due to workload, patient variability, and institutional resources, and its superiority over traditional care remains inconclusive. This study aims to objectively compare ERAS and traditional perioperative care using the QoR-15 questionnaire to assess patient satisfaction, recovery speed, surgical risk reduction, and complication prevention. Rather than solely promoting ERAS, this research seeks to evaluate its applicability, enhance personalized care, and provide scientific evidence for perioperative management optimization.

Conditions

Gynecologic; ERAS

Outcome Measures

Primary Outcomes (1)

• Quality of Recovery-15 (QoR-15) questionnaire

  The Quality of Recovery-15 (QoR-15) questionnaire is a widely used Patient-Reported Outcome Measure (PROM) for evaluating postoperative recovery, including pain, physical function, and emotional well-being.

  5 mins

Study Arms (2)

ERAS care

ERAS emphasizes preoperative education, early interventions (e.g., smoking cessation, anemia management, nutrition optimization), intraoperative strategies (e.g., fluid balance, nausea prevention, temperature control), and postoperative care (e.g., early mobilization, pain control, ileus prevention).

traditional perioperative care (non-ERAS)

Traditional perioperative care (non-ERAS) follows a more conservative approach, often involving prolonged preoperative fasting, liberal fluid administration, routine use of nasogastric tubes, and opioid-based pain management. Postoperatively, patients typically experience delayed oral intake and prolonged bed rest, leading to a longer hospital stay and higher risk of complications such as ileus and deep vein thrombosis.

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women who undergoing routine gynecological surgery, including total or subtotal hysterectomy, myomectomy, oophorectomy, gynecologic cancer staging surgery, cytoreductive surgery, and pelvic exenteration.

You may qualify if:

• Age between 20 and 80 years.
• Undergoing routine gynecological surgery, including total or subtotal hysterectomy, myomectomy, oophorectomy, gynecologic cancer staging surgery, cytoreductive surgery, and pelvic exenteration.
• Cancer patients with an Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.
• Receiving either standard perioperative care or ERAS protocol-based care.

You may not qualify if:

• Age below 20 years.
• Lack of decision-making capacity.
• Undergoing emergency surgery.
• History of clinical depression.
• Undergoing palliative surgery.
• History of chronic pain.

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• National Taiwan University Hospital Hsin-Chu Branch: collaborator

Central Study Contacts

YIPING WANG

CONTACT

886-3-5326151 #523900; G01837@hch.gov.tw

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2025
• First Posted: March 14, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 14, 2025

Record last verified: 2025-03