Trial Outcomes & Findings for Efficacy Side-effect Score (ESS): Development and Evaluation of a New Tool for Patients After Surgery (NCT NCT02143128)
NCT ID: NCT02143128
Last Updated: 2023-09-11
Results Overview
Assess LOS in groups of patients with different types of clinical data records an "all-out algorithms"
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1152 participants
Primary outcome timeframe
28 days
Results posted on
2023-09-11
Participant Flow
Participant milestones
| Measure |
Efficacy Safety Score
Patients assessed using the ESS
Efficacy Safety Score: Evaluation using the score for postoperative patients
|
Verbal Numeric Rating Scale
Patients assessed using VNRS
Verbal Numeric Rating Scale: Patients assessed for postoperative pain using VNRS (0-10)
|
Control
Regular follow up
|
|---|---|---|---|
|
Overall Study
STARTED
|
409
|
417
|
326
|
|
Overall Study
COMPLETED
|
409
|
417
|
326
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Different sites contributing to total.
Baseline characteristics by cohort
| Measure |
Efficacy Safety Score
n=409 Participants
Patients assessed using the ESS
Efficacy Safety Score: Evaluation using the score for postoperative patients
|
Verbal Numeric Rating Scale
n=417 Participants
Patients assessed using VNRS
Verbal Numeric Rating Scale: Patients assessed for postoperative pain using VNRS (0-10)
|
Control
n=326 Participants
Regular follow up
|
Total
n=1152 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
Astana
|
43.4 years
STANDARD_DEVIATION 16.4 • n=228 Participants • Different sites contributing to total.
|
42.4 years
STANDARD_DEVIATION 16.4 • n=227 Participants • Different sites contributing to total.
|
44.9 years
STANDARD_DEVIATION 15.8 • n=224 Participants • Different sites contributing to total.
|
43.6 years
STANDARD_DEVIATION 16.2 • n=679 Participants • Different sites contributing to total.
|
|
Age, Continuous
Krasnodar
|
55.2 years
STANDARD_DEVIATION 14.7 • n=181 Participants • Different sites contributing to total.
|
55.1 years
STANDARD_DEVIATION 15.6 • n=190 Participants • Different sites contributing to total.
|
56 years
STANDARD_DEVIATION 14.9 • n=102 Participants • Different sites contributing to total.
|
55.4 years
STANDARD_DEVIATION 15.1 • n=473 Participants • Different sites contributing to total.
|
|
Sex: Female, Male
Kazakhstan, Astana · Female
|
112 Participants
n=228 Participants • Overall number constitutes of number analyzed at two locations.
|
95 Participants
n=227 Participants • Overall number constitutes of number analyzed at two locations.
|
104 Participants
n=224 Participants • Overall number constitutes of number analyzed at two locations.
|
311 Participants
n=679 Participants • Overall number constitutes of number analyzed at two locations.
|
|
Sex: Female, Male
Kazakhstan, Astana · Male
|
116 Participants
n=228 Participants • Overall number constitutes of number analyzed at two locations.
|
132 Participants
n=227 Participants • Overall number constitutes of number analyzed at two locations.
|
120 Participants
n=224 Participants • Overall number constitutes of number analyzed at two locations.
|
368 Participants
n=679 Participants • Overall number constitutes of number analyzed at two locations.
|
|
Sex: Female, Male
Russia, Krasnodar · Female
|
112 Participants
n=181 Participants • Overall number constitutes of number analyzed at two locations.
|
121 Participants
n=190 Participants • Overall number constitutes of number analyzed at two locations.
|
53 Participants
n=102 Participants • Overall number constitutes of number analyzed at two locations.
|
286 Participants
n=473 Participants • Overall number constitutes of number analyzed at two locations.
|
|
Sex: Female, Male
Russia, Krasnodar · Male
|
69 Participants
n=181 Participants • Overall number constitutes of number analyzed at two locations.
|
69 Participants
n=190 Participants • Overall number constitutes of number analyzed at two locations.
|
49 Participants
n=102 Participants • Overall number constitutes of number analyzed at two locations.
|
187 Participants
n=473 Participants • Overall number constitutes of number analyzed at two locations.
|
|
Region of Enrollment
Kazakhstan
|
228 participants
n=409 Participants
|
227 participants
n=417 Participants
|
224 participants
n=326 Participants
|
679 participants
n=1152 Participants
|
|
Region of Enrollment
Russia
|
181 participants
n=409 Participants
|
190 participants
n=417 Participants
|
102 participants
n=326 Participants
|
473 participants
n=1152 Participants
|
PRIMARY outcome
Timeframe: 28 daysAssess LOS in groups of patients with different types of clinical data records an "all-out algorithms"
Outcome measures
| Measure |
Efficacy Safety Score
n=409 Participants
Patients assessed using the ESS
Efficacy Safety Score: Evaluation using the score for postoperative patients
|
Verbal Numeric Rating Scale
n=417 Participants
Patients assessed using VNRS
Verbal Numeric Rating Scale: Patients assessed for postoperative pain using VNRS (0-10)
|
Control
n=326 Participants
Regular follow up
|
|---|---|---|---|
|
Length of Hospital Stay (LOS)
|
12.7 days
Interval 6.4 to 19.0
|
13.5 days
Interval 7.3 to 19.7
|
14.2 days
Interval 8.0 to 20.4
|
Adverse Events
Efficacy Safety Score
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Verbal Numeric Rating Scale
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr Vladimir Kuklin
Dept of Anaesthesia and Intensive Care, Akershus University Hospital, Norway
Phone: 98838024
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place