Complication,PostoperativeNCT04744376
Predictive Value of QoR15 for Complications
An observational study of Complication,Postoperative and Postoperative Period, run by Mehmet Ali Koç at 8 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complication,Postoperative, Postoperative Period
- What is being tested?
- QoR15, ACS risk calculator and Clavien - Dindo classification
- How many people
- 600 participants
- Where
- 8 sitesTurkey (Türkiye)
- Study dates
- 1 Sep 2019to 1 Sep 2022
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All the patients who undergone major GIS surgery over age of 18
Who may be able to join
- All the patients who undergone major GIS surgery
Who cannot join
- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Turkey (Türkiye)8 sites, 8 recruiting
- Recruiting
Çukurova University School of Medicine Department of General Surgery
Adana
Ismaıl C Eray, MD, +905325535503
- Recruiting
Ankara University School of Medicine Department of General Surgery
Ankara, 06100
Mehmet A Koç, MD, +905333393608, mali.koc@gmail.com
Mehmet A Kuzu, MD, +905326042244, ayhankuzu@gmail.com
- Recruiting
Diskapi Research and Training Hospital
Ankara
Serhat Tokgoz, MD, +905059079666
- Recruiting
Hacettepe University School of Medicine Department of General Surgery
Ankara
Timucin Erol, MD, +905323367645
- Recruiting
Ministry of Health Ankara City Hospital
Ankara
Tezcan Akin, MD, +905056728353
- Recruiting
Antalya Research and Trainig Hospital
Antalya
Cemal O Ensari, MD, +905055025178
Onur I Dincer, MD
- Recruiting
Ataturk University School of Medicine Department of General Surgery
Erzurum
Nurhak Aksungur, MD, +90 5059387141
- Recruiting
Ministry of Health Kayseri City Hospital
Kayseri
Yusuf Sevim, MD, +905325962321
About this study
Official title: Predictive Value of Quality of Recovery - 15 Questionnaire for Morbidity in Major Abdominal Surgery
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.
Read the 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.
- Conditions
- Complication,Postoperative, Postoperative Period
- Being tested
- QoR15, ACS risk calculator, Clavien - Dindo classification
- Keywords
- Postoperative morbidity, Postoperaitve mortality, QoR15, ACS risk calculator, Recovery
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QoR15Other
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.
ACS risk calculatorOther
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.
Clavien - Dindo classificationOther
It is a classification for postoperative complications.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: QoR15; Other: ACS risk calculator; Other: Clavien - Dindo classification |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: postoperative day 30
Secondary outcomes (5)
Reliability of QoR - 15 on postoperative complications
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.
Measured: In the preoperative period
Quality of Recovery
The aim is to investigate the effect of preoperative conditions of patients on postoperative recovery with QoR - 15 questionnaire.
Measured: In the preoperative period
Quality of Recovery
The aim is to investigate the effect of preoperative conditions of patients on postoperative recovery with QoR - 15 questionnaire.
Measured: postoperative day 1
Quality of Recovery
The aim is to investigate the effect of preoperative conditions of patients on postoperative recovery with QoR - 15 questionnaire.
Measured: postoperative day 7
Quality of Recovery
The aim is to investigate the effect of preoperative conditions of patients on postoperative recovery with QoR - 15 questionnaire.
Measured: postoperative day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2021
- Study start1 Sep 2019
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complication,PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Mehmet Ali Koç
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mehmet Ali Koç, Ankara University
- Investigators
- Mehmet A Kuzu, MD, Study director, Ankara University School of Medicine Department of General SurgeryMehmet A Koç, MD, Principal investigator, Ankara University School of Medicine Departmernt of General Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04744376
- Sponsor's protocol ID
- U1111-1264-3497
- Status last verified
- May 2022
- First submitted
- 29 Jan 2021
- Last updated
- 10 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of Quality of Recovery - 15 Questionnaire for Morbidity in Major Abdominal Surgery
- ClinicalTrials.gov ID
- NCT04744376
- Acronym / sponsor ID
- U1111-1264-3497
- Conditions
- Complication,Postoperative, Postoperative Period
- Keywords
- Postoperative morbidity, Postoperaitve mortality, QoR15, ACS risk calculator, Recovery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Mehmet Ali KoçUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 9 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Major GIS Surgery | – | Other: QoR15, Other: ACS risk calculator, Other: Clavien - Dindo classificationThe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All the patients who undergone major GIS surgery over age of 18
Key inclusion criteria (1 listed)
- All the patients who undergone major GIS surgery
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QoR15Quality 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 | Major GIS Surgery |
| ACS risk calculatorAmerican 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 | Major GIS Surgery |
| Clavien - Dindo classificationIt is a classification for postoperative complications. | Other | Major GIS Surgery |
Primary outcome
Predictive value of QoR - 15 on postoperative complications
Time frame: 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.
Predictive value of QoR - 15 on postoperative complications
Time frame: 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.
Predictive value of QoR - 15 on postoperative complications
Time frame: 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.
Predictive value of QoR - 15 on postoperative complications
Time frame: 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.
5 secondary outcomes
Reliability of QoR - 15 on postoperative complications
Time frame: In the preoperative period
Quality of Recovery
Time frame: In the preoperative period
Quality of Recovery
Time frame: postoperative day 1
Quality of Recovery
Time frame: postoperative day 7
Quality of Recovery
Time frame: postoperative day 30
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mehmet A Kuzu, MD study director
Ankara University School of Medicine Department of General Surgery
Mehmet A Koç, MD principal investigator
Ankara University School of Medicine Departmernt of General Surgery
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Complication,Postoperative and Postoperative Period, run by Mehmet Ali Koç at 8 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mehmet A Koç, MD (+905333393608, mali.koc@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictive value of QoR - 15 on postoperative complications (time frame: In the preoperative period). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2022.