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

NCT ID: NCT06878079

Last Updated: 2025-03-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 130 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-03-31
• Study Completion Date: 2026-06-30

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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).

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital Hsin-Chu Branch

OTHER

Sponsor Role: collaborator

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

YIPING WANG

Role: CONTACT

G01837@hch.gov.tw

886-3-5326151 #523900

Other Identifiers

202407159RINB

Identifier Type: -

Identifier Source: org_study_id