Protective and Risk Factors for QoR-15 for Major Abdominal Surgery

Patients Undergoing Major Abdominal Surgery Clinical Trial

— Q15MAS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05980910
• Other study ID #: 20236103RIND
• Status: Recruiting
• Start date: August 21, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: July 2023
• Source: National Taiwan University Hospital
• Contact: Weihan Chou, MD.
• Phone: *886-921815831
• Email: brokenarrowchou[@]yahoo.com.tw
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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..

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: December 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Patients Undergoing Major Abdominal Surgery

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hosipital Hsin Chu Branch	HsinChu
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
National Taiwan University Hospital	National Taiwan University Hospital Hsin-Chu Branch

Country where clinical trial is conducted

Taiwan, 

References & Publications (3)

Johnson A, Rice AN, Titch JF, Gupta DK. Identifying Components Necessary for an Enhanced Recovery After Surgery Pathway for Elective Intracranial Surgery: An Improvement Project Using the Quality of Recovery-15 Score. World Neurosurg. 2019 Oct;130:e423-e430. doi: 10.1016/j.wneu.2019.06.108. Epub 2019 Jul 4. — View Citation

Myles PS. More than just morbidity and mortality - quality of recovery and long-term functional recovery after surgery. Anaesthesia. 2020 Jan;75 Suppl 1:e143-e150. doi: 10.1111/anae.14786. — View Citation

Stark PA, Myles PS, Burke JA. Development and psychometric evaluation of a postoperative quality of recovery score: the QoR-15. Anesthesiology. 2013 Jun;118(6):1332-40. doi: 10.1097/ALN.0b013e318289b84b. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	QoR-15 Scores at postoperative day one and day three	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