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Vaginal or Laparoscopic Hysterectomy, Persistent Postsurgical Pain

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01537731
First Posted: February 23, 2012
Last Update Posted: October 9, 2013
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.
Information provided by (Responsible Party):
Arvi Yli-Hankala, Tampere University Hospital
  Purpose
Previous studies have shown that chronic pain after hysterectomy is common. The aim of this study is to investigate the incidence of chronic pain after vaginal or laparoscopic hysterectomy for benign reasons. The aim of this prospective study is also to study the role of anesthetics, surgery and other possible predictors for pain 6 months after hysterectomy.

Condition Intervention
Chronic Postsurgical Pain Procedure: vaginal or laparoscopic hysterectomy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Chronic Pain After Vaginal or Laparoscopic Hysterectomy for Benign Conditions

Resource links provided by NLM:


Further study details as provided by Arvi Yli-Hankala, Tampere University Hospital:

Primary Outcome Measures:
  • Presence of persistent postsurgical pain as measured at 6 months after surgery. [ Time Frame: five years ]

Secondary Outcome Measures:
  • Severity, location, characteristics of persistent postsurgical pain. [ Time Frame: five years ]
  • Effect of postsurgical pain on activity, sleep. [ Time Frame: five years ]

Estimated Enrollment: 225
Study Start Date: April 2009
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
hysterectomy
Patient who previously underwent vaginal or laparoscopic hysterectomy
Procedure: vaginal or laparoscopic hysterectomy
vaginal hysterectomy or laparoscopic hysterectomy

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Women who undergo vaginal or laparoscopic hysterectomy for benign conditions.
Criteria

Inclusion Criteria:

  • Patients who undergo vaginal or laparoscopic hysterectomy for benign conditions
  • Age 18-69 years
  • Gender: female
  • ASA status 1-3

Exclusion Criteria:

  • Body Mass Index over 35
  • Diabetes mellitus
  • Liver disease
  • Preoperative use of opioids
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01537731


Locations
Finland
Tampere University Hospital
Tampere, Finland, 33521
Sponsors and Collaborators
Tampere University Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Arvi Yli-Hankala, professor, Tampere University Hospital
ClinicalTrials.gov Identifier: NCT01537731     History of Changes
Other Study ID Numbers: R08031M R09003
First Submitted: January 10, 2012
First Posted: February 23, 2012
Last Update Posted: October 9, 2013
Last Verified: October 2013