Predictive Value of QoR15 for Complications

NCT04744376 | Unknown

• 1 other identifier: U1111-1264-3497
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 8

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.

Conditions

Complication,Postoperative; Postoperative Period

Keywords

Postoperative morbidity; Postoperaitve mortality; QoR15; ACS risk calculator; Recovery

Outcome Measures

Primary Outcomes (4)

• Predictive value of QoR - 15 on postoperative complications

  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.

  In the preoperative period

• Predictive value of QoR - 15 on postoperative complications

  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.

  postoperative day 1

• Predictive value of QoR - 15 on postoperative complications

  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.

  postoperative day 7

• Predictive value of QoR - 15 on postoperative complications

  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.

  postoperative day 30

Secondary Outcomes (5)

• Reliability of QoR - 15 on postoperative complications

  In the preoperative period

• Quality of Recovery

  In the preoperative period

• Quality of Recovery

  postoperative day 1

• Quality of Recovery

  postoperative day 7

• Quality of Recovery

  postoperative day 30

Study Arms (1)

Major GIS Surgery

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

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

Interventions

QoR15 OTHER

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.

Major GIS Surgery

ACS risk calculator OTHER

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.

Major GIS Surgery

Clavien - Dindo classification OTHER

It is a classification for postoperative complications.

Major GIS Surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All the patients who undergone major GIS surgery over age of 18

You may qualify if:

• All the patients who undergone major GIS surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Mehmet Ali Koç: lead

Study Sites (8)

Çukurova University School of Medicine Department of General Surgery

Adana, Turkey (Türkiye)

RECRUITING

Ankara University School of Medicine Department of General Surgery

Ankara, 06100, Turkey (Türkiye)

RECRUITING

Diskapi Research and Training Hospital

Ankara, Turkey (Türkiye)

RECRUITING

Hacettepe University School of Medicine Department of General Surgery

Ankara, Turkey (Türkiye)

RECRUITING

Ministry of Health Ankara City Hospital

Ankara, Turkey (Türkiye)

RECRUITING

Antalya Research and Trainig Hospital

Antalya, Turkey (Türkiye)

RECRUITING

Ataturk University School of Medicine Department of General Surgery

Erzurum, Turkey (Türkiye)

RECRUITING

Ministry of Health Kayseri City Hospital

Kayseri, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mehmet A Kuzu, MD

  Ankara University School of Medicine Department of General Surgery

  STUDY DIRECTOR

• Mehmet A Koç, MD

  Ankara University School of Medicine Departmernt of General Surgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mehmet A Koç, MD

CONTACT

+905333393608; mali.koc@gmail.com

Mehmet A Kuzu, MD

CONTACT

+905326042244; ayhankuzu@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 29, 2021
• First Posted: February 9, 2021
• Study Start: September 1, 2019
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: May 10, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (8)