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Finhyst 2006: Study on Morbidity of Hysterectomies in Finland

This study has been completed.
Sponsor:
Collaborator:
Helsinki University Central Hospital
Information provided by (Responsible Party):
Paivi Harkki, Society for Gynecological Surgery in Finland
ClinicalTrials.gov Identifier:
NCT00744172
First received: August 28, 2008
Last updated: November 17, 2014
Last verified: November 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 Society for Gynecological Surgery in Finland:

Primary Outcome Measures:
  • Safety of hysterectomy [ Time Frame: 1.1-31.12.2006 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Cost-effectiveness [ Time Frame: 1.1.-31.12.2006 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Society for Gynecological Surgery in Finland

Additional 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
Study First Received: August 28, 2008
Last Updated: November 17, 2014
Health Authority: Finland: Ethics Committee

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

ClinicalTrials.gov processed this record on November 27, 2014