Clinical trial NCT05980910: Protective and Risk Factors for QoR-15 for Major Abdominal Surgery
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Patients Undergoing Major Abdominal Surgery
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: National Taiwan University Hospital Hsin-Chu Branch
First posted: 2023-08-08
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult Patients receiving major abdominal surgery

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

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..

Eligibility criteria: 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.

Primary outcomes:
measure: QoR-15 Scores at postoperative day one and day three
timeFrame: 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: HsinChu
country: Taiwan
facility: National Taiwan University Hosipital Hsin Chu Branch
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References:
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.
citation: 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.
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.