Predictive Value of QoR15 for Complications

NCT ID: NCT04744376

Last Updated: 2022-05-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-01

Study Completion Date

2022-09-01

Brief Summary

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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

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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

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Complication,Postoperative Postoperative Period

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

QoR15

Intervention Type 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.

ACS risk calculator

Intervention Type 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.

Clavien - Dindo classification

Intervention Type OTHER

It is a classification for postoperative complications.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Clavien - Dindo classification

It is a classification for postoperative complications.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mehmet Ali Koç

OTHER

Sponsor Role lead

Responsible Party

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Mehmet Ali Koç

MD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Mehmet A Kuzu, MD

Role: STUDY_DIRECTOR

Ankara University School of Medicine Department of General Surgery

Mehmet A Koç, MD

Role: PRINCIPAL_INVESTIGATOR

Ankara University School of Medicine Departmernt of General Surgery

Locations

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Çukurova University School of Medicine Department of General Surgery

Adana, , Turkey (Türkiye)

Site Status RECRUITING

Ankara University School of Medicine Department of General Surgery

Ankara, , Turkey (Türkiye)

Site Status RECRUITING

Diskapi Research and Training Hospital

Ankara, , Turkey (Türkiye)

Site Status RECRUITING

Hacettepe University School of Medicine Department of General Surgery

Ankara, , Turkey (Türkiye)

Site Status RECRUITING

Ministry of Health Ankara City Hospital

Ankara, , Turkey (Türkiye)

Site Status RECRUITING

Antalya Research and Trainig Hospital

Antalya, , Turkey (Türkiye)

Site Status RECRUITING

Ataturk University School of Medicine Department of General Surgery

Erzurum, , Turkey (Türkiye)

Site Status RECRUITING

Ministry of Health Kayseri City Hospital

Kayseri, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Mehmet A Koç, MD

Role: CONTACT

+905333393608

Mehmet A Kuzu, MD

Role: CONTACT

+905326042244

Facility Contacts

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Ismaıl C Eray, MD

Role: primary

+905325535503

Mehmet A Koç, MD

Role: primary

+905333393608

Mehmet A Kuzu, MD

Role: backup

+905326042244

Serhat Tokgoz, MD

Role: primary

+905059079666

Timucin Erol, MD

Role: primary

+905323367645

Tezcan Akin, MD

Role: primary

+905056728353

Cemal O Ensari, MD

Role: primary

+905055025178

Nurhak Aksungur, MD

Role: primary

+90 5059387141

Yusuf Sevim, MD

Role: primary

+905325962321

Other Identifiers

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U1111-1264-3497

Identifier Type: -

Identifier Source: org_study_id

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