Trial Outcomes & Findings for Predictors of Postoperative Pain (NCT NCT02996994)
NCT ID: NCT02996994
Last Updated: 2023-08-31
Results Overview
VAS is a validated 100 millimeter scale with no pain as 0 mm and worst pain as 100 mm. Subjects drew a vertical line on the scale corresponding to their pain level.
Recruitment status
COMPLETED
Target enrollment
364 participants
Primary outcome timeframe
postoperative day 1 (POD1)
Results posted on
2023-08-31
Participant Flow
Participant milestones
| Measure |
Reconstructive Surgery
Eligible trials enrolled subjects undergoing vaginal reconstructive surgery for pelvic organ prolapse from 2009 to 2015.
|
|---|---|
|
Overall Study
STARTED
|
364
|
|
Overall Study
COMPLETED
|
364
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Predictors of Postoperative Pain
Baseline characteristics by cohort
| Measure |
Reconstructive Surgery
n=364 Participants
Eligible trials enrolled subjects undergoing vaginal reconstructive surgery for pelvic organ prolapse from 2009 to 2015.
|
|---|---|
|
Age, Continuous
|
59.44 years
STANDARD_DEVIATION 11.42 • n=5 Participants
|
|
Sex: Female, Male
Female
|
364 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
351 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Missing
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
364 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: postoperative day 1 (POD1)VAS is a validated 100 millimeter scale with no pain as 0 mm and worst pain as 100 mm. Subjects drew a vertical line on the scale corresponding to their pain level.
Outcome measures
| Measure |
Reconstructive Surgery
n=364 Participants
Eligible trials enrolled subjects undergoing vaginal reconstructive surgery for pelvic organ prolapse from 2009 to 2015.
|
|---|---|
|
Visual Analog Scale (VAS) Pain Score
|
38.16 mm
Standard Deviation 24.89
|
Adverse Events
Reconstructive Surgery
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place