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Clinical Trials/NCT04744376
NCT04744376
Unknown
Not Applicable

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

Mehmet Ali Koç8 sites in 1 country600 target enrollmentSeptember 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Complication,Postoperative
Sponsor
Mehmet Ali Koç
Enrollment
600
Locations
8
Primary Endpoint
Predictive value of QoR - 15 on postoperative complications
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2019
End Date
September 1, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Mehmet Ali Koç
Responsible Party
Sponsor Investigator
Principal Investigator

Mehmet Ali Koç

MD

Ankara University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Predictive value of QoR - 15 on postoperative complications

Time Frame: postoperative day 30

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.

Secondary Outcomes

  • Quality of Recovery(postoperative day 30)
  • Reliability of QoR - 15 on postoperative complications(In the preoperative period)

Study Sites (8)

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