Predictive Value of QoR15 for Complications

• Conditions: Complication,Postoperative; Postoperative Period
• Interventions: Other: QoR15; Other: ACS risk calculator; Other: Clavien - Dindo classification

• Registration Number: NCT04744376
• Lead Sponsor: Mehmet Ali Koç

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.

Study Timeline

• Study Start: 2019-09-01
• Study First Submitted: 2021-01-29
• Study First Submitted QC: 2021-02-03
• Study First Posted: 2021-02-09
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-07
• Last Update Posted: 2022-05-10
• Primary Completion: 2022-09-01
• Study Completion: 2022-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Major GIS Surgery	QoR15	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
Major GIS Surgery	ACS risk calculator	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
Major GIS Surgery	Clavien - Dindo classification	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

Primary Outcome Measures

Name	Time	Method
Predictive value of QoR - 15 on postoperative complications	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 Outcome Measures

Name	Time	Method
Quality of Recovery	postoperative day 30	The aim is to investigate the effect of preoperative conditions of patients on postoperative recovery with QoR - 15 questionnaire.
Reliability of QoR - 15 on postoperative complications	In the preoperative period	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.

Trial Locations

Locations (8)

Çukurova University School of Medicine Department of General Surgery; 🇹🇷 Adana, Turkey

Hacettepe University School of Medicine Department of General Surgery; 🇹🇷 Ankara, Turkey

Antalya Research and Trainig Hospital; 🇹🇷 Antalya, Turkey

Ankara University School of Medicine Department of General Surgery; 🇹🇷 Ankara, Turkey

Diskapi Research and Training Hospital; 🇹🇷 Ankara, Turkey

Ministry of Health Ankara City Hospital; 🇹🇷 Ankara, Turkey

Ataturk University School of Medicine Department of General Surgery; 🇹🇷 Erzurum, Turkey

Ministry of Health Kayseri City Hospital; 🇹🇷 Kayseri, Turkey