NCT04010474

Brief 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 parameters of SAS.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
308

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2017

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

July 3, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 8, 2019

Completed
Last Updated

July 9, 2019

Status Verified

July 1, 2019

Enrollment Period

4 months

First QC Date

July 3, 2019

Last Update Submit

July 8, 2019

Conditions

Keywords

ComplicationMortalityModifiedSurgical Apgar Score

Outcome Measures

Primary Outcomes (1)

  • 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.

    01.06.2017 - 30.09.2017

Interventions

Four intraoperative factors 1. Lowest heart rate (HR), 2. Lowest mean arterial pressure (MAP) 3. Estimated blood loss 4. Operation time

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • Subject has major surgery
  • More than 18 years

You may not qualify if:

  • Pregnant
  • Younger than 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Namigar Turgut

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Namigar Turgut, Prof.Dr

    University of Health Seciences, Okmeydani Training and Research Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof.Dr

Study Record Dates

First Submitted

July 3, 2019

First Posted

July 8, 2019

Study Start

June 1, 2017

Primary Completion

September 30, 2017

Study Completion

October 30, 2017

Last Updated

July 9, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations