NCT07764276

Brief Summary

Enhanced Recovery After Surgery (ERAS) is a multidisciplinary perioperative care program designed to reduce surgical stress, accelerate postoperative recovery, and improve clinical outcomes. This prospective, non-randomized study aims to evaluate the effectiveness of an ERAS program in patients undergoing gynecologic surgery at National Taiwan University Hospital Hsin-Chu Branch. Patients who choose to participate in the ERAS program will receive perioperative care according to the institutional ERAS protocol, while those who choose conventional perioperative care will serve as the comparison group. Perioperative outcomes, postoperative recovery, postoperative complications, pain scores, and other clinical outcomes will be compared between the two groups to evaluate the clinical impact of implementing an ERAS program.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
14mo left

Started May 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress67%
May 2024Dec 2027

Study Start

First participant enrolled

May 16, 2024

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

August 4, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 13, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

August 13, 2026

Status Verified

August 1, 2026

Enrollment Period

2.5 years

First QC Date

August 4, 2026

Last Update Submit

August 12, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Time to First Ambulation

    Time from return to the hospital ward after surgery to the first ambulation, defined as leaving the bed and standing independently.

    Up to 3 days after surgery

  • Postoperative Pain Score

    Postoperative pain intensity will be assessed using the Numerical Rating Scale (NRS), ranging from 0 to 10, with 0 indicating no pain and 10 indicating the worst possible pain. Higher scores indicate greater pain intensity.

    4, 8, 16, 24, 48 hours after surgery

Secondary Outcomes (6)

  • Time to First Gas Passage

    Up to 7 days after surgery

  • Time to First Stool Passage

    Up to 7 days after surgery

  • Time to removal of Foley catheter

    Up to 7 days after surgery

  • Postoperative nausea or vomiting

    Up to 7 days after surgery

  • Overall Postoperative Complication Rate

    Up to 90 days after surgery

  • +1 more secondary outcomes

Study Arms (2)

Enhanced Recovery After Surgery (ERAS)

EXPERIMENTAL

Participants receive perioperative care according to the institutional ERAS protocol, including preoperative education, preoperative carbohydrate intake, optimized anesthesia, multimodal analgesia, early oral feeding, early mobilization, and other evidence-based perioperative care measures.

Other: Enhanced Recovery After Surgery (ERAS)

Conventional Perioperative Care

ACTIVE COMPARATOR

Participants receive conventional perioperative care according to routine institutional practice without implementation of the ERAS protocol.

Other: Conventional Perioperative Care

Interventions

A multidisciplinary perioperative care program designed to reduce surgical stress and enhance postoperative recovery.

Enhanced Recovery After Surgery (ERAS)

Standard perioperative care according to routine institutional practice.

Conventional Perioperative Care

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female scheduled for laparotomic gynecologic surgery (including hysterectomy, myomectomy, adenomyomectomy, oophorectomy or oophrocystectomy, staging surgery, debulking surgery or interval debulking surgery)
  • years old or older
  • American Society of Anesthesiologists Physical Status classification I to III.

You may not qualify if:

  • Female undergo laparoscopic surgery but are converted to laparotomic surgery
  • History of delayed gastric emptying, gastrointestinal motility disorders or chronic pain
  • Female undergo emergent surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital Hsin-Chu Branch

Hsinchu, Taiwan

RECRUITING

MeSH Terms

Interventions

Enhanced Recovery After Surgery

Intervention Hierarchy (Ancestors)

Perioperative CareSurgical Procedures, Operative

Study Officials

  • Chia-Yi Lee, MD

    National Taiwan University Hospital Hsin-Chu Branch

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2026

First Posted

August 13, 2026

Study Start

May 16, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2027

Last Updated

August 13, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations