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Finhyst 2006: Study on Morbidity of Hysterectomies in Finland (Finhyst 2006)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00744172
First Posted: August 29, 2008
Last Update Posted: November 18, 2014
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.
Collaborator:
Helsinki University Central Hospital
Information provided by (Responsible Party):
Paivi Harkki, Society for Gynecological Surgery in Finland
  Purpose
The purpose of this study is to analyze prospectively all hysterectomies performed in Finland for benign indications including all 46 public hospitals performing hysterectomies and also 7 private clinics. Hypothesis is that vaginal and laparoscopic hysterectomies are safe and cost-effective methods of hysterectomy.

Condition Intervention
Morbidity of Hysterectomy Procedure: laparoscopy Procedure: vaginal Procedure: abdominal

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Finhyst 2006: Incidence, Methods, Complications and Effect on Quality of Life of Hysterectomies in Finland in 2006

Resource links provided by NLM:


Further study details as provided by Paivi Harkki, Society for Gynecological Surgery in Finland:

Primary Outcome Measures:
  • Safety of hysterectomy [ Time Frame: 1.1-31.12.2006 ]

Secondary Outcome Measures:
  • Cost-effectiveness [ Time Frame: 1.1.-31.12.2006 ]

Enrollment: 5279
Study Start Date: January 2006
Study Completion Date: December 2010
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: I
laparoscopy
Procedure: laparoscopy
laparoscopic hysterectomy
Active Comparator: 2
vaginal
Procedure: vaginal
vaginal hysterectomy
Active Comparator: 3
abdominal
Procedure: abdominal
abdominal hysterectomy

Detailed Description:
This Finhyst 2006 study evaluates nationwidely methods, indications, concomitant procedures, complications, hospital stay and convalescence time of all types of hysterectomies with questionnaires filled by doctors and patients. In addition, in the area of Helsinki University Central Hospital also the effect of quality of life and cost-effectiveness is studied.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Bening indications for hysterectomy

Exclusion Criteria:

  • Malignant indications for hysterectomy
  • Postpartum hysterectomy
  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): NCT00744172


Locations
Finland
Helsinki University Central Hospital
Helsinki, Finland, 00029
Sponsors and Collaborators
Society for Gynecological Surgery in Finland
Helsinki University Central Hospital
Investigators
Study Director: Päivi SM Härkki, MD Member of Society of Gynecological Surgery in Finland
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Paivi Harkki, MD PhD, Society for Gynecological Surgery in Finland
ClinicalTrials.gov Identifier: NCT00744172     History of Changes
Other Study ID Numbers: Finhyst 2006
First Submitted: August 28, 2008
First Posted: August 29, 2008
Last Update Posted: November 18, 2014
Last Verified: November 2014

Keywords provided by Paivi Harkki, Society for Gynecological Surgery in Finland:
hysterectomy
vaginal
laparoscopy
abdominal
complication
quality of life
cost-effectiveness
Morbidity of three types of hysterectomy