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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01706549
Other study ID # R11190
Secondary ID
Status Completed
Phase N/A
First received October 10, 2012
Last updated June 1, 2015
Start date March 2012
Est. completion date December 2013

Study information

Verified date June 2015
Source Tampere University Hospital
Contact n/a
Is FDA regulated No
Health authority Finland: Ethics Committee
Study type Observational

Clinical Trial Summary

Patients undergone either laparoscopic or vaginal hysterectomy will called for a clinical examination 1-3 years after surgery, if they suffer from pain 6 months after surgery. The aims of the study are:

1. to reveal whether the pain is postsurgical in nature, or if there are any other reasons for the pain.

2. to reveal the type of pain, neuropathic, nociceptive or idiopathic.

3. to reveal the impact of pain on quality of life.


Description:

Patients undergone either laparoscopic or vaginal hysterectomy will called for a clinical examination 1-3 years after surgery, if they suffer from pain 6 months after surgery. All patients were treated in Pirkanmaa District Hospital and the anesthesia was either propofol-infusion or sevoflurane gas with remifentanil-infusion.

6months after the surgery, questionnaires about pelvic pain were sent to the patients. Patients still having pain at that time, were invited for detailed sensory and gynecological examinations.


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date December 2013
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 69 Years
Eligibility Inclusion Criteria:

- hysterectomy 1-3 years previously

- suffering from pain 6months postsurgically

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Finland Tampere University Hospital Tampere

Sponsors (1)

Lead Sponsor Collaborator
Tampere University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Type of Chronic Pain After Hysterectomy Number of participants with probable neuropathic, possible neuropathic, pain had subsided and other type of pain. 1-3 years after hysterectomy No
Secondary Quality of Life After Hysterectomy Quality of life as measured by the SF-36, which consists of 8 scales. 1-3 years after hysterectomy No
Secondary Is the Pain Due to Hysterectomy? Number of patients having posthysterectomy pain versus other pain 1-3 years No
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