Clinical Analysis of Pain After Hysterectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01706549
Recruitment Status : Completed
First Posted : October 15, 2012
Results First Posted : June 2, 2015
Last Update Posted : February 13, 2017
Information provided by (Responsible Party):
Tampere University Hospital

Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Postoperative Pain

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

Participant Flow:   Overall Study
    Posthysterectomy Pain

  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
Postoperative Pain Observational study on posthysterectomy pain

Baseline Measures
   Postoperative Pain 
Overall Participants Analyzed 
[Units: Participants]
[Units: Years]
Mean (Standard Deviation)
 51  (6.6) 
[Units: Participants]
Count of Participants
<=18 years      0   0.0% 
Between 18 and 65 years      15  93.8% 
>=65 years      1   6.3% 
[Units: Participants]
Count of Participants
Female      16 100.0% 
Male      0   0.0% 
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

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.  

  Serious Adverse Events

  Other Adverse Events

  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

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

Responsible Party: Tampere University Hospital Identifier: NCT01706549     History of Changes
Other Study ID Numbers: R11190
First Submitted: October 10, 2012
First Posted: October 15, 2012
Results First Submitted: December 19, 2014
Results First Posted: June 2, 2015
Last Update Posted: February 13, 2017