Predictive Value of QoR15 for Complications

Sponsor
Mehmet Ali Koç (Other)
Overall Status
Recruiting
CT.gov ID
NCT04744376
Collaborator
(none)
600
8
36
75
2.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
600 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Predictive Value of Quality of Recovery - 15 Questionnaire for Morbidity in Major Abdominal Surgery
Actual Study Start Date :
Sep 1, 2019
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Sep 1, 2022

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Predictive value of QoR - 15 on postoperative complications [In the preoperative period]

    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.

  2. Predictive value of QoR - 15 on postoperative complications [postoperative day 1]

    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.

  3. Predictive value of QoR - 15 on postoperative complications [postoperative day 7]

    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.

  4. 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

  1. 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.

  2. Quality of Recovery [In the preoperative period]

    The aim is to investigate the effect of preoperative conditions of patients on postoperative recovery with QoR - 15 questionnaire.

  3. Quality of Recovery [postoperative day 1]

    The aim is to investigate the effect of preoperative conditions of patients on postoperative recovery with QoR - 15 questionnaire.

  4. Quality of Recovery [postoperative day 7]

    The aim is to investigate the effect of preoperative conditions of patients on postoperative recovery with QoR - 15 questionnaire.

  5. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Çukurova University School of Medicine Department of General Surgery Adana Turkey
2 Ankara University School of Medicine Department of General Surgery Ankara Turkey 06100
3 Diskapi Research and Training Hospital Ankara Turkey
4 Hacettepe University School of Medicine Department of General Surgery Ankara Turkey
5 Ministry of Health Ankara City Hospital Ankara Turkey
6 Antalya Research and Trainig Hospital Antalya Turkey
7 Ataturk University School of Medicine Department of General Surgery Erzurum Turkey
8 Ministry of Health Kayseri City Hospital Kayseri Turkey

Sponsors and Collaborators

  • Mehmet Ali Koç

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mehmet Ali Koç, MD, Ankara University
ClinicalTrials.gov Identifier:
NCT04744376
Other Study ID Numbers:
  • U1111-1264-3497
First Posted:
Feb 9, 2021
Last Update Posted:
May 10, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Mehmet Ali Koç, MD, Ankara University
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 10, 2022