- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06203171
Preoperative Evaluation on Perioperative Complications
Preoperative Evaluation: Impact on Perioperative Complications
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Not managing patients well before, during, and after surgery can lead to more health problems and deaths. In wealthy countries, 3-16% of patients face major issues during this time, and 0.4-0.8% of them might end up permanently disabled or dead. Checking patients before surgery helps identify risks, improves their health and fitness, and lowers the chances of problems during this period.
On another note, even though the right surgeries can save lives and prevent injuries, the growing cost of healthcare is a big issue worldwide. In the United States, the rising cost is a concern for everyone, including insurance companies and drug makers. It's believed that treatments that don't really help could be causing about 30% of these high costs.
No matter the surgery, patient's health, or anesthesia plan, checking patients before surgery is key to safe anesthesia for people of all ages. A thorough check before surgery helps manage patient care during this period, prevents surgery cancellations due to patient issues, and helps keep the surgery schedule efficient and cost-effective.
There's no agreed-upon definition for checking patients before anesthesia in medical literature. This check involves looking at the patient's medical history, interviews, physical exams, and test results. Anesthesiologists might also talk to other healthcare workers for more information or help with anesthesia care during this period. The information gathered can help educate the patient, plan for care during and after surgery, and manage pain.
However, it's not clear how much these pre-surgery checks actually improve patient outcomes. A recent study found that seeing a doctor before surgery didn't reduce, but actually increased, the chances of problems after surgery. This study looks at how well pre-surgery anesthesia checks at our center help prevent problems during this period
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Canik
-
Samsun, Canik, Turkey, 55090
- Samsun University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Elective surgery
- ASA ≤ 3 patients
- Patients over 18 years of age
Exclusion Criteria:
- Emergency surgeries
- ASA > 3 patients
- Pregnant women
- Age > 80
- Age < 18
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Group C
Patients with perioperative complications
|
Routine laboratory parameters requested from patients; Direct lung Radiograph and Electrocardiography results were evaluated and preoperative consultations and recommendations requested from the patients were recorded.
Type of anesthesia, operation performed, operation duration, intraoperative blood and fluid losses, intraoperative and postoperative complications that develop within the first 24 hours, additional problems that develop (pain, postoperative nausea and vomiting, hypothermia, change of consciousness, bleeding and unplanned transfer to the intensive care unit).
postanesthesia recovery The length of stay in the room, length of hospital stay, and method of discharge were recorded.
The effects of preoperative laboratory, imaging methods and required consultations on intraoperative and postoperative complications in the first 24 hours were evaluated.
|
|
Group non-C
Patients with no perioperative complications
|
Routine laboratory parameters requested from patients; Direct lung Radiograph and Electrocardiography results were evaluated and preoperative consultations and recommendations requested from the patients were recorded.
Type of anesthesia, operation performed, operation duration, intraoperative blood and fluid losses, intraoperative and postoperative complications that develop within the first 24 hours, additional problems that develop (pain, postoperative nausea and vomiting, hypothermia, change of consciousness, bleeding and unplanned transfer to the intensive care unit).
postanesthesia recovery The length of stay in the room, length of hospital stay, and method of discharge were recorded.
The effects of preoperative laboratory, imaging methods and required consultations on intraoperative and postoperative complications in the first 24 hours were evaluated.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perioperative hemodynamic complications
Time Frame: Up to 24 hours
|
New developments in the perioperative period hemodynamic complications
|
Up to 24 hours
|
|
New developments in the perioperative period respiratuary complications
Time Frame: Up to 24 hours
|
Respiratory Failure; Oxygen saturation < 90 or tachypnea (respiratory rate > 20/min
|
Up to 24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time of hospital
Time Frame: 2 weeks
|
Time in hospital after surgery
|
2 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: OZGUR KOMURCU, 1, Samsun University
Publications and helpful links
General Publications
- Colla CH, Morden NE, Sequist TD, Schpero WL, Rosenthal MB. Choosing wisely: prevalence and correlates of low-value health care services in the United States. J Gen Intern Med. 2015 Feb;30(2):221-8. doi: 10.1007/s11606-014-3070-z. Epub 2014 Nov 6. Erratum In: J Gen Intern Med. 2016 Apr;31(4):450.
- Rose J, Weiser TG, Hider P, Wilson L, Gruen RL, Bickler SW. Estimated need for surgery worldwide based on prevalence of diseases: a modelling strategy for the WHO Global Health Estimate. Lancet Glob Health. 2015 Apr 27;3 Suppl 2(Suppl 2):S13-20. doi: 10.1016/S2214-109X(15)70087-2.
- Siddaiah H, Patil S, Shelvan A, Ehrhardt KP, Stark CW, Ulicny K, Ridgell S, Howe A, Cornett EM, Urman RD, Kaye AD. Preoperative laboratory testing: Implications of "Choosing Wisely" guidelines. Best Pract Res Clin Anaesthesiol. 2020 Jun;34(2):303-314. doi: 10.1016/j.bpa.2020.04.006. Epub 2020 Apr 22.
- Beckerleg W, Kobewka D, Wijeysundera DN, Sood MM, McIsaac DI. Association of Preoperative Medical Consultation With Reduction in Adverse Postoperative Outcomes and Use of Processes of Care Among Residents of Ontario, Canada. JAMA Intern Med. 2023 May 1;183(5):470-478. doi: 10.1001/jamainternmed.2023.0325.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- SUKAEK-2023 17/16
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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