Finhyst 2006: Study on Morbidity of Hysterectomies in Finland - Full Text View

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
Hysterectomy	Procedure: laparoscopy Procedure: vaginal Procedure: abdominal

MedlinePlus related topics:

Hysterectomy

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study

Official Title:	Finhyst 2006: Incidence, Methods, Complications and Effect on Quality of Life of Hysterectomies in Finland in 2006

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
Estimated Study Completion Date:	December 2010
Primary Completion Date:	December 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
I: Active Comparator laparoscopy	Procedure: laparoscopy laparoscopic hysterectomy
2: Active Comparator vaginal	Procedure: vaginal vaginal hysterectomy
3: Active Comparator 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

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

Investigators


Study Director:	Päivi SM Härkki, MD	Member of Society of Gynecological Surgery in Finland

More Information

Responsible Party:	Society for Gynecological Surgery in Finland (GSF) ( Päivi Härkki, member of GSF, MD PhD )
Study ID Numbers:	Finhyst 2006
First Received:	August 28, 2008
Last Updated:	August 30, 2008
ClinicalTrials.gov Identifier:	NCT00744172
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

Study placed in the following topic categories:

Quality of Life

ClinicalTrials.gov processed this record on October 24, 2008

Sponsors and Collaborators:	Society for Gynecological Surgery in Finland Helsinki University
Information provided by:	Society for Gynecological Surgery in Finland
ClinicalTrials.gov Identifier:	NCT00744172