Predictive Value of QoR15 for Complications

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Complication,Postoperative, Postoperative Period

Intervention / Treatment
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* Other: QoR15
* Other: ACS risk calculator
* Other: Clavien - Dindo classification


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All the patients who undergone major GIS surgery Exclusion Criteria: Patients who has an expected mortality in six months because of the primary disease Patients who received parenteral nutrition before surgery Patients who has a previous major abdominal surgery Patients who do not accept the surgery Patients with a disability who require a nursing care

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Major GIS Surgery<br>The cohort includes all the patients who undergone major gastrointestinal (GIS) surgery. Major GIS surgery includes: Gastric surgery Duodenal surgery Pancreatic surgery Hepatobiliary surgery Colonic surgery Rectal surgery | Other: QoR15<br>* 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.<br>Other: ACS risk calculator<br>* 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.<br>Other: Clavien - Dindo classification<br>* It is a classification for postoperative complications.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Predictive value of QoR - 15 on postoperative complications | QoR - 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. | In the preoperative period | 
| Predictive value of QoR - 15 on postoperative complications | QoR - 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. | postoperative day 1 | 
| Predictive value of QoR - 15 on postoperative complications | QoR - 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. | postoperative day 7 | 
| Predictive value of QoR - 15 on postoperative complications | QoR - 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. | postoperative day 30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reliability of QoR - 15 on postoperative complications | QoR15 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. | In the preoperative period | 
| Quality of Recovery | The aim is to investigate the effect of preoperative conditions of patients on postoperative recovery with QoR - 15 questionnaire. | In the preoperative period | 
| Quality of Recovery | The aim is to investigate the effect of preoperative conditions of patients on postoperative recovery with QoR - 15 questionnaire. | postoperative day 1 | 
| Quality of Recovery | The aim is to investigate the effect of preoperative conditions of patients on postoperative recovery with QoR - 15 questionnaire. | postoperative day 7 | 
| Quality of Recovery | The aim is to investigate the effect of preoperative conditions of patients on postoperative recovery with QoR - 15 questionnaire. | postoperative day 30 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postoperative morbidity, Postoperaitve mortality, QoR15, ACS risk calculator, Recovery