Clinical Analysis of Pain After Hysterectomy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tampere University Hospital
ClinicalTrials.gov Identifier:
NCT01706549
First received: October 10, 2012
Last updated: June 1, 2015
Last verified: June 2015
Results First Received: December 19, 2014  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Postoperative Pain

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
January 2012-December 2013. Patients recruited from previous studies. Clinical evaluation at the Hospital on the basis of volunteering.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Posthysterectomy Pain Observational study on posthysterectomy pain. Participants recruited from previous studies. Recruitment completed.

Participant Flow:   Overall Study
    Posthysterectomy Pain  
STARTED     16  
COMPLETED     16  
NOT COMPLETED     0  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Patients undergone hysterectomy and reportteri to have SUFFERED from pain 6 months postoperatively and volunteered for a clinical examination.

Reporting Groups
  Description
Postoperative Pain Observational study on posthysterectomy pain

Baseline Measures
    Postoperative Pain  
Number of Participants  
[units: participants]
  16  
Age  
[units: Years]
Mean (Standard Deviation)
  51  (6.6)  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     15  
>=65 years     1  
Gender  
[units: participants]
 
Female     16  
Male     0  
Region of Enrollment  
[units: participants]
 
Finland     16  
Quality of life (SF-36) [1]
[units: units on a scale]
Mean (Standard Deviation)
 
Physical Functioning     76.9  (29.2)  
Role Physical     57.8  (45.7)  
Role Emotional     54.1  (43.9)  
Vitality     55.3  (24.8)  
Mental health     70.0  (18.2)  
Social Functioning     70.6  (26.8)  
Bodily Pain     65.5  (29.2)  
General health     56.8  (20.1)  
[1] All dimensions are mean of points from 0-100, where 100 is the best score. Getting 0 points equals to poor performance.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Type of Chronic Pain After Hysterectomy   [ Time Frame: 1-3 years after hysterectomy ]

2.  Secondary:   Is the Pain Due to Hysterectomy?   [ Time Frame: 1-3 years ]

3.  Secondary:   Quality of Life After Hysterectomy   [ Time Frame: 1-3 years after hysterectomy ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Low participation rate. Inadequate filling of questionnaires. Time from surgery to clinical examination varied from 10 to 44 months. No preoperative quality of life measure.


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: MD Satu Pokkinen
Organization: Tampere University Hospital
phone: +3583311611
e-mail: Satu.pokkinen@pshp.fi


No publications provided


Responsible Party: Tampere University Hospital
ClinicalTrials.gov Identifier: NCT01706549     History of Changes
Other Study ID Numbers: R11190
Study First Received: October 10, 2012
Results First Received: December 19, 2014
Last Updated: June 1, 2015
Health Authority: Finland: Ethics Committee