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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00776880
Other study ID # NMU-FY2008-MZ08
Secondary ID NJFY080921
Status Completed
Phase N/A
First received October 20, 2008
Last updated December 22, 2009
Start date January 2009
Est. completion date December 2009

Study information

Verified date November 2009
Source Nanjing Medical University
Contact n/a
Is FDA regulated No
Health authority China: Ethics Committee
Study type Observational

Clinical Trial Summary

American Society of Anesthesiologists (ASA) physical status scale has been used worldwide for assessing the status of patients before operation. However, merely the value of ASA scale did not give enough information of patients to determine their prognosis and improvement of outcomes. Since 1948, World Health Organization (WHO) defined health as the state of complete physical, mental and social well-being and not merely the absence of disease or infirmity. Therefore, the investigators hypothesized that the ASA scale only was needed to be modified and should be replaced by a comprehensive gauge to evaluate the status of patients in depth. Based on this thought, the investigators used a new system, i.e., physical-psycho-social (PPS) scale, to assess the overall state before surgical procedures.


Recruitment information / eligibility

Status Completed
Enrollment 1500
Est. completion date December 2009
Est. primary completion date December 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Patients undergoing elective surgical operation

- Age from 18-65 years

Exclusion Criteria:

- Age < 18 years or > 65 years

- Not willing to participate in this study

- Patients from emergency department

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Other:
ASA scale
ASA scale evaluation before operation
PPS scale
PPS scale evaluation before operation

Locations

Country Name City State
China Nanjing Maternal and Child Health Care Hospital Nanjing Jiangsu

Sponsors (1)

Lead Sponsor Collaborator
Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time of recovery Six months after operation. No
Secondary Intraoperative consumption of drugs 1 day after operation Yes
Secondary Incidence of side events 72 hours after operation Yes
Secondary Hospitalization days From 0 min after operation to the time duration of discharge home, this measure would be varied in different patients No
Secondary Psychological state Six months after operation Yes
Secondary Life quality Six months after operation No
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