Clinical trial NCT04744376: Predictive Value of QoR15 for Complications
Official title: Predictive Value of Quality of Recovery - 15 Questionnaire for Morbidity in Major Abdominal Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Complication,Postoperative
Postoperative Period
Keywords: Postoperative morbidity
Postoperaitve mortality
QoR15
ACS risk calculator
Recovery
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2021-02-09
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All the patients who undergone major GIS surgery over age of 18

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.

Eligibility criteria: 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

Primary outcomes:
measure: Predictive value of QoR - 15 on postoperative complications
timeFrame: In the preoperative period
measure: Predictive value of QoR - 15 on postoperative complications
timeFrame: postoperative day 1
measure: Predictive value of QoR - 15 on postoperative complications
timeFrame: postoperative day 7
measure: Predictive value of QoR - 15 on postoperative complications
timeFrame: postoperative day 30
Secondary outcomes:
measure: Reliability of QoR - 15 on postoperative complications
timeFrame: In the preoperative period
measure: Quality of Recovery
timeFrame: In the preoperative period
measure: Quality of Recovery
timeFrame: postoperative day 1
measure: Quality of Recovery
timeFrame: postoperative day 7
measure: Quality of Recovery
timeFrame: postoperative day 30
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Çukurova University School of Medicine Department of General Surgery
city: Ankara
country: Turkey
facility: Ankara University School of Medicine Department of General Surgery
city: Ankara
country: Turkey
facility: Diskapi Research and Training Hospital
city: Ankara
country: Turkey
facility: Hacettepe University School of Medicine Department of General Surgery
city: Ankara
country: Turkey
facility: Ministry of Health Ankara City Hospital
city: Antalya
country: Turkey
facility: Antalya Research and Trainig Hospital
city: Erzurum
country: Turkey
facility: Ataturk University School of Medicine Department of General Surgery
city: Kayseri
country: Turkey
facility: Ministry of Health Kayseri City Hospital
Study officials:
affiliation: Ankara University School of Medicine Department of General Surgery
name: Mehmet A Kuzu, MD
role: STUDY_DIRECTOR
affiliation: Ankara University School of Medicine Departmernt of General Surgery
name: Mehmet A Koç, MD
role: PRINCIPAL_INVESTIGATOR
References: