Predictive Value of QoR15 for Complications

Complication,Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04744376
• Other study ID #: U1111-1264-3497
• Status: Recruiting
• Start date: September 1, 2019
• Est. completion date: September 1, 2022

Study information

• Verified date: May 2022
• Source: Ankara University
• Contact: Mehmet A Koç, MD
• Phone: +905333393608
• Email: mali.koc[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: September 1, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Complication,Postoperative
• Postoperative Complications
• Postoperative Period

Intervention

Other:
• QoR15
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.
• ACS 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.
• Clavien - Dindo classification
It is a classification for postoperative complications.

Locations

Country	Name	City	State
Turkey	Çukurova University School of Medicine Department of General Surgery	Adana
Turkey	Ankara University School of Medicine Department of General Surgery	Ankara
Turkey	Diskapi Research and Training Hospital	Ankara
Turkey	Hacettepe University School of Medicine Department of General Surgery	Ankara
Turkey	Ministry of Health Ankara City Hospital	Ankara
Turkey	Antalya Research and Trainig Hospital	Antalya
Turkey	Ataturk University School of Medicine Department of General Surgery	Erzurum
Turkey	Ministry of Health Kayseri City Hospital	Kayseri

Sponsors (1)

Lead Sponsor	Collaborator
Mehmet Ali Koç

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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