Predictive Value of QoR15 for Complications

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

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.

Study Overview

• Status: Recruiting
• Conditions: Complication,Postoperative; Postoperative Period
• Intervention / Treatment: Other: QoR15; Other: ACS risk calculator; Other: Clavien - Dindo classification

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.

• Study Type: Observational
• Enrollment (Anticipated): 600

Contacts and Locations

• Study Contact: Name: Mehmet A Koç, MD; Phone Number: +905333393608; Email: mali.koc@gmail.com
• Study Contact Backup: Name: Mehmet A Kuzu, MD; Phone Number: +905326042244; Email: ayhankuzu@gmail.com

Study Locations

• Turkey
  • Adana, Turkey
    • Recruiting
    • Çukurova University School of Medicine Department of General Surgery
    • Contact: Ismaıl C Eray, MD; Phone Number: +905325535503
  • Ankara, Turkey, 06100
    • Recruiting
    • Ankara University School of Medicine Department of General Surgery
    • Contact: Mehmet A Koç, MD; Phone Number: +905333393608; Email: mali.koc@gmail.com
    • Contact: Mehmet A Kuzu, MD; Phone Number: +905326042244; Email: ayhankuzu@gmail.com
    • Sub-Investigator: Kaan Sunter, MD
    • Sub-Investigator: Kadir Y Turker, MD
    • Sub-Investigator: Siyar Ersoz, MD
  • Ankara, Turkey
    • Recruiting
    • Diskapi Research and Training Hospital
    • Contact: Serhat Tokgoz, MD; Phone Number: +905059079666
  • Ankara, Turkey
    • Recruiting
    • Hacettepe University School of Medicine Department of General Surgery
    • Contact: Timucin Erol, MD; Phone Number: +905323367645
  • Ankara, Turkey
    • Recruiting
    • Ministry of Health Ankara City Hospital
    • Contact: Tezcan Akin, MD; Phone Number: +905056728353
  • Antalya, Turkey
    • Recruiting
    • Antalya Research and Trainig Hospital
    • Contact: Cemal O Ensari, MD; Phone Number: +905055025178
    • Sub-Investigator: Onur I Dincer, MD
  • Erzurum, Turkey
    • Recruiting
    • Ataturk University School of Medicine Department of General Surgery
    • Contact: Nurhak Aksungur, MD; Phone Number: +90 5059387141
  • Kayseri, Turkey
    • Recruiting
    • Ministry of Health Kayseri City Hospital
    • Contact: Yusuf Sevim, MD; Phone Number: +905325962321

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All the patients who undergone major GIS surgery over age of 18

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Major GIS Surgery; 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; 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.; Other: 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.; Other: Clavien - Dindo classification; It is a classification for postoperative complications.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mehmet Ali Koç
• Investigators: Principal Investigator: Mehmet A Koç, MD, Ankara University School of Medicine Departmernt of General Surgery; Study Director: Mehmet A Kuzu, MD, Ankara University School of Medicine Department of General Surgery

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2019
• Primary Completion (Anticipated): September 1, 2022
• Study Completion (Anticipated): September 1, 2022

Study Registration Dates

• First Submitted: January 29, 2021
• First Submitted That Met QC Criteria: February 3, 2021
• First Posted (Actual): February 9, 2021

Study Record Updates

• Last Update Posted (Actual): May 10, 2022
• Last Update Submitted That Met QC Criteria: May 7, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Recovery; Postoperative morbidity; QoR15; Postoperaitve mortality; ACS risk calculator
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications
• Other Study ID Numbers: U1111-1264-3497

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No