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Predictive Value of QoR15 for Complications

M

Mehmet Ali Koç

Status

Unknown

Conditions

Postoperative Period
Complication,Postoperative

Treatments

Other: Clavien - Dindo classification
Other: QoR15
Other: ACS risk calculator

Study type

Observational

Funder types

Other

Identifiers

NCT04744376
U1111-1264-3497

Details and patient eligibility

About

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.

Full 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.

Enrollment

600 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

600 participants in 1 patient group

Major GIS Surgery
Description:
The cohort includes all the patients who undergone major gastrointestinal (GIS) surgery. Major GIS surgery includes: 1. Gastric surgery 2. Duodenal surgery 3. Pancreatic surgery 4. Hepatobiliary surgery 5. Colonic surgery 6. Rectal surgery
Treatment:
Other: Clavien - Dindo classification
Other: ACS risk calculator
Other: QoR15

Trial contacts and locations

8

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Central trial contact

Mehmet A Koç, MD; Mehmet A Kuzu, MD

Data sourced from clinicaltrials.gov

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