Trial Outcomes & Findings for Clinical Analysis of Pain After Hysterectomy (NCT NCT01706549)
NCT ID: NCT01706549
Last Updated: 2017-02-13
Results Overview
Number of participants with probable neuropathic, possible neuropathic, pain had subsided and other type of pain.
COMPLETED
16 participants
1-3 years after hysterectomy
2017-02-13
Participant Flow
January 2012-December 2013. Patients recruited from previous studies. Clinical evaluation at the Hospital on the basis of volunteering.
Participant milestones
| Measure |
Posthysterectomy Pain
Observational study on posthysterectomy pain. Participants recruited from previous studies. Recruitment completed.
|
|---|---|
|
Overall Study
STARTED
|
16
|
|
Overall Study
COMPLETED
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical Analysis of Pain After Hysterectomy
Baseline characteristics by cohort
| Measure |
Postoperative Pain
n=16 Participants
Observational study on posthysterectomy pain
|
|---|---|
|
Age, Continuous
|
51 Years
STANDARD_DEVIATION 6.6 • n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Gender
Female
|
16 Participants
n=5 Participants
|
|
Gender
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Finland
|
16 participants
n=5 Participants
|
|
Quality of life (SF-36)
Physical Functioning
|
76.9 units on a scale
STANDARD_DEVIATION 29.2 • n=5 Participants
|
|
Quality of life (SF-36)
Role Physical
|
57.8 units on a scale
STANDARD_DEVIATION 45.7 • n=5 Participants
|
|
Quality of life (SF-36)
Role Emotional
|
54.1 units on a scale
STANDARD_DEVIATION 43.9 • n=5 Participants
|
|
Quality of life (SF-36)
Vitality
|
55.3 units on a scale
STANDARD_DEVIATION 24.8 • n=5 Participants
|
|
Quality of life (SF-36)
Mental health
|
70.0 units on a scale
STANDARD_DEVIATION 18.2 • n=5 Participants
|
|
Quality of life (SF-36)
Social Functioning
|
70.6 units on a scale
STANDARD_DEVIATION 26.8 • n=5 Participants
|
|
Quality of life (SF-36)
Bodily Pain
|
65.5 units on a scale
STANDARD_DEVIATION 29.2 • n=5 Participants
|
|
Quality of life (SF-36)
General health
|
56.8 units on a scale
STANDARD_DEVIATION 20.1 • n=5 Participants
|
PRIMARY outcome
Timeframe: 1-3 years after hysterectomyPopulation: Women undergone hysterectomy previously and reported having pain at the site of surgery six months after surgery
Number of participants with probable neuropathic, possible neuropathic, pain had subsided and other type of pain.
Outcome measures
| Measure |
Posthysterectomy Pain
n=16 Participants
Observational study on posthysterectomy pain. Participants recruited from previous studies. Recruitment completed.
|
|---|---|
|
Type of Chronic Pain After Hysterectomy
Probable neuropathic pain
|
5 participants
|
|
Type of Chronic Pain After Hysterectomy
Possible neuropathic pain
|
4 participants
|
|
Type of Chronic Pain After Hysterectomy
Subsided pain
|
6 participants
|
|
Type of Chronic Pain After Hysterectomy
Other type of pain
|
1 participants
|
SECONDARY outcome
Timeframe: 1-3 years after hysterectomyQuality of life as measured by the SF-36, which consists of 8 scales.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1-3 yearsNumber of patients having posthysterectomy pain versus other pain
Outcome measures
| Measure |
Posthysterectomy Pain
n=16 Participants
Observational study on posthysterectomy pain. Participants recruited from previous studies. Recruitment completed.
|
|---|---|
|
Is the Pain Due to Hysterectomy?
|
15 participants
|
Adverse Events
Posthysterectomy Pain
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