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Predictive Value of QoR15 for Complications

Predictive Value of Quality of Recovery - 15 Questionnaire for Morbidity in Major Abdominal Surgery

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04744376
Enrollment
600
Registered
2021-02-09
Start date
2019-09-01
Completion date
2022-09-01
Last updated
2022-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complication,Postoperative, Postoperative Period

Keywords

Postoperative morbidity, Postoperaitve mortality, QoR15, ACS risk calculator, Recovery

Brief summary

Surgical operations and recovery after anesthesia is a complex process. Studies examining the interventions performed in the preoperative period often focus on classical clinical outcomes such as postoperative organ dysfunction, morbidity or complications. Postoperative recovery of the patient is rarely considered the most important outcome variable in interventional studies. In this study, the Quality of recovery 15 (QoR - 15) questionnaire that measures the recovery score, and the American college of surgeons surgical risk calculator have been used to compare the predictive values of patient's preoperative condition on postoperative recovery period and possible morbidity and mortality.

Detailed description

Surgical operations and recovery after anesthesia is a complex process. Studies examining the interventions performed in the preoperative period often focus on classical clinical outcomes such as postoperative organ dysfunction, morbidity or complications. Postoperative recovery of the patient is rarely considered the most important outcome variable in interventional studies. In this study, the effects of both preoperative patient condition and postoperative recovery on morbidity and mortality are investigated. In order to evaluate the ability of QoR - 15 to predict postoperative complications patients who underwent major abdominal surgery, patients answer the Quality of Recovery 15 questionnaire both in the preoperative and postoperative periods. In addition, the risk of postoperative complications is calculated in the preoperative period with the American college of surgeons (ACS) surgical risk calculator. Finally, postoperative complications of all patients are recorded according to Clavien Dindo classification. The primary goal is to understand the predictive value of the QOR15 score on postoperative complications. Secondarily, it is to compare of predictive values of QoR15 with ACS risk calculator on morbidity and mortality. Another secondary aim is to investigate the effect of preoperative conditions of patients on postoperative recovery.

Interventions

OTHERQoR15

Quality of Recovery 15 questionnaire (QoR-15) is a measurement tool that evaluates the recovery quality of patients after surgery and anesthesia by the patient himself.

OTHERACS risk calculator

American College of Surgeons risk calculator is a risk prediction tool for abdominal surgery. It calculates the risk of possible postoperative complications according to the type of surgery, ASA score, and patients' preoperative co-morbidities.

OTHERClavien - Dindo classification

It is a classification for postoperative complications.

Sponsors

Mehmet Ali Koç
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

All the patients who undergone major GIS surgery

Exclusion criteria

1. Patients who has an expected mortality in six months because of the primary disease 2. Patients who received parenteral nutrition before surgery 3. Patients who has a previous major abdominal surgery 4. Patients who do not accept the surgery 5. Patients with a disability who require a nursing care

Design outcomes

Primary

MeasureTime frameDescription
Predictive value of QoR - 15 on postoperative complicationsIn the preoperative periodQoR - 15 questionnaire is a measurement tool that evaluates the recovery quality of patients after surgery and anesthesia by the patient himself (patient reported outcome measure - PROM). However it has a potential to predict postoperative complication risk. Preoperative and postoperative scores of QoR - 15 will be evaluated for a cut-off value regarding postoperative complications which is recorded according to Clavien Dindo classification.

Secondary

MeasureTime frameDescription
Quality of RecoveryIn the preoperative periodThe aim is to investigate the effect of preoperative conditions of patients on postoperative recovery with QoR - 15 questionnaire.
Reliability of QoR - 15 on postoperative complicationsIn the preoperative periodQoR15 scores are recorded and the relation of the scores and postoperative complications will be evaluated. After that predictive value of QoR - 15 will be compared to the predictive value of the widely used ACS surgical risk calculator to determine the reliability of QoR - 15 for postoperative complications.

Countries

Turkey (Türkiye)

Contacts

Primary ContactMehmet A Koç, MD
mali.koc@gmail.com+905333393608
Backup ContactMehmet A Kuzu, MD
ayhankuzu@gmail.com+905326042244

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026