Clinical Analysis of Pain After Hysterectomy

This study is currently recruiting participants.
Verified March 2012 by Tampere University Hospital
Sponsor:
Information provided by (Responsible Party):
Tampere University Hospital
ClinicalTrials.gov Identifier:
NCT01706549
First received: October 10, 2012
Last updated: NA
Last verified: March 2012
History: No changes posted
  Purpose

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.

Condition
Pain After Hysterectomy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Chronic Pain After Hysterectomy, Qualitative Analysis of Pain and Its Impact on Quality of Life

Resource links provided by NLM:


Further study details as provided by Tampere University Hospital:

Primary Outcome Measures:
  • Type of chronic pain after hysterectomy [ Time Frame: 1-3 years after hysterectomy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life after hysterectomy [ Time Frame: 1-3 years after hysterectomy ] [ Designated as safety issue: No ]
  • Is the pain postsurgical in nature [ Time Frame: 1-3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 45
Study Start Date: March 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Posthysterectomy pain

  Eligibility

Ages Eligible for Study:   18 Years to 69 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Women undergone hysterectomy for 1-3 years previously and suffering from persistent pain 6 months after surgery. The patients are invited to participate in this study, if they have participated in previous studies "Sevoflurane, Propofol, Postoperative pain" by Yli-Hankala and Pokkinen and study:" Vaginal hysterectomy, laparoscopic hysterectomy, postoperative pain" by Yli-Hankala and Pokkinen.

Criteria

Inclusion Criteria:

  • hysterectomy 1-3 years previously
  • suffering from pain 6months postsurgically

Exclusion Criteria:

-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01706549

Contacts
Contact: Satu M Pokkinen, MD +3583311611 satu.pokkinen@pshp.fi
Contact: Maija-Liisa Kalliomäki, MD, PhD +3583311611 maija-liisa.kalliomaki@pshp.fi

Locations
Finland
Tampere University Hospital Recruiting
Tampere, Finland, 33200
Contact: Satu M Pokkinen, MD     +3583311611     satu.pokkinen@pshp.fi    
Contact: Maija-Liisa Kalliomäki, MD, PhD     +3583311611     maija-liisa.kalliomaki@pshp.fi    
Principal Investigator: Maija-Liisa Kalliomäki, MD, PhD            
Sponsors and Collaborators
Tampere University Hospital
  More Information

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
Last Updated: October 10, 2012
Health Authority: Finland: Ethics Committee

Keywords provided by Tampere University Hospital:
Chronic pain
Hysterectomy
Quality of life

ClinicalTrials.gov processed this record on June 13, 2013