Perioperative/Postoperative ComplicationsNCT04010474
Surgical APGAR Score and Modified Surgical APGAR Score
An observational study of Perioperative/Postoperative Complications, run by Namigar Turgut at 1 site in Turkey (Türkiye).
Trial summary
In this study we aimed to define a new modified SAS is to predict the incidence of postoperative complication and mortality in major abdominal and orthopedic surgery. We also identify the effectivity of this modified scoring system composed of the duration of operation in addition to the three intraoperative… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Perioperative/Postoperative Complications
- What is being tested?
- Modified Surgical APGAR Score
- Type of treatment
- Surgery or procedure
- How many people
- 308 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2017to 30 Oct 2017
- 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: Patients who underwent elective major surgery (Abdominal and Orthopedic surgery) were included (n=308) After the operation modified SAS (mSAS) was calculated by adding the duration of the operation to data used in calculation of the SAS (Table 1.). Observed complications and related conditions were also noted. Table 1. Modified Surgical Apgar Score (mSAS) mSAS 0 1 2 3 4 Estimated blood loss, ml >1000 601-1000 101-600 ≤100 - Lowest MAP*, mmHg <40 40-54 55-69 ≥70 - Lowest HR**, beats per min >85 76-85 66-75 56-65 ≤55 Time -4 -3 -2 -1 0 Duration of operation (hour) >8 7.01-8 5.01-7 3.01-5 0-3 * MAP=Mean arterial pressure
Who may be able to join
- Subject has major surgery
- More than 18 years
Who cannot join
- Pregnant
- Younger than 18
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Surgical APGAR Score and Modified Surgical APGAR Score in Predicting Possible Postoperative Complications in Major Surgery
In this study we aimed to define a new modified SAS is to predict the incidence of postoperative complication and mortality in major abdominal and orthopedic surgery. We also identify the effectivity of this modified scoring system composed of the duration of operation in addition to the three intraoperative parameters of SAS.
- Being tested
- Modified Surgical APGAR Score
- Keywords
- Complication, Mortality, Modified, Surgical Apgar Score
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Surgical APGAR ScoreProcedure or surgery
Four intraoperative factors
- Lowest heart rate (HR),
- Lowest mean arterial pressure (MAP)
- Estimated blood loss
- Operation time
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Surgical APGAR Score and Modified Surgical APGAR Score in Predicting Possible Postoperative Complications in Major Surgery
Operation time should be included as a simple, objective and practical indication of the SAS risk score in the major operations in our study including a single-center, prospective 308 case study, as it can be seen as an independent predictor of postoperative mortality and complications.
Measured: 01.06.2017 - 30.09.2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2019
- Study start1 Jun 2017
- Primary completion30 Sep 2017
- Study completion30 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perioperative/Postoperative ComplicationsStudies 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
- 308 participants (actual)
Sponsor and investigators
- Lead sponsor
- Namigar Turgut
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Namigar Turgut, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
- Investigators
- Namigar Turgut, Prof.Dr, Study director, University of Health Seciences, Okmeydani Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04010474
- Sponsor's protocol ID
- 09.05.2017 658
- Status last verified
- Jul 2019
- First submitted
- 3 Jul 2019
- Last updated
- 9 Jul 2019
- 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 9 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Surgical APGAR Score and Modified Surgical APGAR Score in Predicting Possible Postoperative Complications in Major Surgery
- ClinicalTrials.gov ID
- NCT04010474
- Acronym / sponsor ID
- 09.05.2017 658
- Keywords
- Complication, Mortality, Modified, Surgical Apgar Score
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 308 participants (actual)
- Lead sponsor
- Namigar TurgutUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 30 Oct 2017 (actual)
- First posted
- 8 Jul 2019 (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.
In this study we aimed to define a new modified SAS is to predict the incidence of postoperative complication and mortality in major abdominal and orthopedic surgery. We also identify the effectivity of this modified scoring system composed of the duration of operation in addition to the three intraoperative parameters of SAS.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent elective major surgery (Abdominal and Orthopedic surgery) were included (n=308) After the operation modified SAS (mSAS) was calculated by adding the duration of the operation to data used in calculation of the SAS (Table 1.). Observed complications and related conditions were also noted. Table 1. Modified Surgical Apgar Score (mSAS) mSAS 0 1 2 3 4 Estimated blood loss, ml >1000 601-1000 101-600 ≤100 - Lowest MAP*, mmHg <40 40-54 55-69 ≥70 - Lowest HR**, beats per min >85 76-85 66-75 56-65 ≤55 Time -4 -3 -2 -1 0 Duration of operation (hour) >8 7.01-8 5.01-7 3.01-5 0-3 * MAP=Mean arterial pressure
Key inclusion criteria (2 listed)
- Subject has major surgery
- More than 18 years
Key exclusion criteria (2 listed)
- Pregnant
- Younger than 18
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 |
|---|---|---|
| Modified Surgical APGAR ScoreFour intraoperative factors 1. Lowest heart rate (HR), 2. Lowest mean arterial pressure (MAP) 3. Estimated blood loss 4. Operation time | Procedure or surgery | – |
Primary outcome
Comparison of Surgical APGAR Score and Modified Surgical APGAR Score in Predicting Possible Postoperative Complications in Major Surgery
Time frame: 01.06.2017 - 30.09.2017
Operation time should be included as a simple, objective and practical indication of the SAS risk score in the major operations in our study including a single-center, prospective 308 case study, as it can be seen as an independent predictor of postoperative mortality and complications.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2019.
- Individual participant dataSharing planned: No
Related trials for Perioperative/Postoperative Complications
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
Not yet recruiting
Prediction and Prevention of Postoperative Mortality and Morbidity
Dementia, Postoperative Delirium (POD)
Active, not recruitingObservational study
Association of POCD With Circulating Biomarkers in Patients Undergoing TUR of Bladder Tumor
Cognitive Decline, Urinary Bladder Cancer
Active, not recruiting
Prehabilitation in Pancreatic Surgery
Pancreatic Cancer, Periampullary Cancer
Not yet recruitingPhase 4
Perioperative Dutasteride for Hemorrhage Control in Bipolar TURP Under Anticoagulation.
Benign Prostatic Hyperplasia, Postoperative Hemorrhage
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.
Namigar Turgut, Prof.Dr study director
University of Health Seciences, Okmeydani Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Perioperative/Postoperative Complications, run by Namigar Turgut at 1 site 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 9 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of Surgical APGAR Score and Modified Surgical APGAR Score in Predicting Possible Postoperative Complications in Major Surgery (time frame: 01.06.2017 - 30.09.2017). 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 9 Jul 2019.