Protective and Risk Factors for QoR-15 for Major Abdominal Surgery (Q15MAS)

August 27, 2023 updated by: National Taiwan University Hospital

Investigation of Protective and Risk Factors for Quality of Recovery-15 (QoR-15) Score for Patients Undergoing Major Abdominal Surgery- an Multi-center Observational Study

Investigation of post-operative recovery among adult patients receiving major abdominal surgery.

Study Overview

Status

Recruiting

Conditions

Detailed Description

This prospective observational clinical trial aims to evaluate the postoperative recovery status of patients undergoing major abdominal surgery using the Quality of Recovery-15 (QoR-15) questionnaire. The QoR-15 has been highly regarded for its importance and research value in evaluating postoperative recovery in previous studies and has been validated in numerous languages, including Mandarin. Furthermore, the QoR-15 is not only a reflection of the subjective recovery quality but has also been found to be associated with objective indicators such as postoperative complications. Therefore, establishing a database of postoperative QoR-15 variations can play a significant role in improving healthcare quality and serves as a validation indicator for many Enhanced Recovery After Surgery (ERAS) outcomes. The study aims to contribute to improving postoperative care and inform future research in the context of ERAS programs..

Study Type

Observational

Enrollment (Estimated)

350

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Taiwan
      • HsinChu, Taiwan, 302
        • Not yet recruiting
        • National Taiwan University Hosipital Hsin Chu Branch
        • Contact:
      • Taipei, Taiwan, 100225

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult Patients receiving major abdominal surgery

Description

Inclusion Criteria:

  • (1) Age 18years and above.
  • (2) Undergoing elective abdominal surgery with an expected surgical time of at least two hours and an expected hospital stay of at least two days.

Exclusion Criteria:

  • (1) Age under 18 years. (2) Incapacity to give informed consent. (3) Emergency surgery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Major abdominal surgery
Patients undergoing elective major abdominal surgery. The definition of major surgery is the estimated surgery time >= 2 hours.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
QoR-15 Scores at postoperative day one and day three
Time Frame: 72 hours
Measure the QoR-15(Quality of Recovery-15) scores on the first day and third day after major abdominal surgery. The QoR-15 score, derived from a 15-item questionnaire using an 11-point numeric rating scale, ranges from 0 to 150, with higher scores indicating better recovery quality.
72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Collaborators

National Taiwan University Hospital Hsin-Chu Branch

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 21, 2023

Primary Completion (Estimated)

July 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

July 21, 2023

First Submitted That Met QC Criteria

July 31, 2023

First Posted (Actual)

August 8, 2023

Study Record Updates

Last Update Posted (Actual)

August 30, 2023

Last Update Submitted That Met QC Criteria

August 27, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 20236103RIND

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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