GynecologicNCT06878079
ERAS and Postoperative Recovery in Gynecologic Patients: A QoR-15 Study
An observational study of Gynecologic and ERAS, run by National Taiwan University Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years, women only
- Conditions the study is for
- Gynecologic, ERAS
- Type of treatment
- Pill or oral medicine
- How many people
- 130 participants
- Where
- No sites listed yet
- Study dates
- Mar 2025to Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women who undergoing routine gynecological surgery, including total or subtotal hysterectomy, myomectomy, oophorectomy, gynecologic cancer staging surgery, cytoreductive surgery, and pelvic exenteration.
Who may be able to join
- 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.
Who cannot join
- Age below 20 years.
- Lack of decision-making capacity.
- Undergoing emergency surgery.
- History of clinical depression.
- Undergoing palliative surgery.
- History of chronic pain.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Assessing Enhanced Recovery After Surgery (ERAS) Intervention Impact on Postoperative Recovery in Gynecological Patients Using 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. 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 mins
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2025
- Study startMar 2025 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GynecologicStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Taiwan University Hospital Hsin-Chu Branch
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06878079
- Sponsor's protocol ID
- 202407159RINB
- Status last verified
- Mar 2025
- First submitted
- 10 Mar 2025
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Enhanced Recovery After Surgery (ERAS) Intervention Impact on Postoperative Recovery in Gynecological Patients Using QoR-15 Questionnaire
- ClinicalTrials.gov ID
- NCT06878079
- Acronym / sponsor ID
- 202407159RINB
- Conditions
- Gynecologic, ERAS
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- National Taiwan University Hospital Hsin-Chu Branch
- Study start
- Mar 2025 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 14 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women who undergoing routine gynecological surgery, including total or subtotal hysterectomy, myomectomy, oophorectomy, gynecologic cancer staging surgery, cytoreductive surgery, and pelvic exenteration.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- Age below 20 years.
- Lack of decision-making capacity.
- Undergoing emergency surgery.
- History of clinical depression.
- Undergoing palliative surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Quality of Recovery-15 (QoR-15) questionnaire
Time frame: 5 mins
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Gynecologic
RecruitingPhase 2
Testing the Use of Neratinib or the Combination of Neratinib and Palbociclib Targeted Treatment for HER2+ Solid Tumors (A ComboMATCH Treatment Trial)
Malignant Female Reproductive System Neoplasm, Malignant Solid Neoplasm
Recruiting
INtegrating Systematic PatIent-Reported Evaluations in Multi-Disciplinary Tumor Boards: The INSPIRE Study
Breast Cancer, Corpus Uteri Cancer
Not yet recruiting
Gut Microbiome in Patients With Lung and Melanoma Cancer and Intestinal Microbiota in Gynecologic Cancers
Non Small Cell Lung Cancer, Melanoma (Skin Cancer)
Enrolling by invitation
Peer Ambassador in Gyn Onc Trials
Ovarian Cancer
Active, not recruitingPhase 2
Pembrolizumab and Lenvatinib in Clear Cell Ovarian Cancer
Ovarian Clear Cell Carcinoma, Gynecologic Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Gynecologic and ERAS, run by National Taiwan University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact YIPING WANG (886-3-5326151 #523900, G01837@hch.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Recovery-15 (QoR-15) questionnaire (time frame: 5 mins). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2025.