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

November 17, 2014 updated by: Paivi Harkki, Society for Gynecological Surgery in Finland

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

5279

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Helsinki, Finland, 00029
        • Helsinki University Central Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Bening indications for hysterectomy

Exclusion Criteria:

  • Malignant indications for hysterectomy
  • Postpartum hysterectomy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: I
laparoscopy
Procedure: laparoscopy
laparoscopic hysterectomy
Active Comparator: 2
vaginal
Procedure: vaginal
vaginal hysterectomy
Active Comparator: 3
abdominal
Procedure: abdominal
abdominal hysterectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety of hysterectomy
Time Frame: 1.1-31.12.2006
1.1-31.12.2006

Secondary Outcome Measures

Outcome Measure
Time Frame
Cost-effectiveness
Time Frame: 1.1.-31.12.2006
1.1.-31.12.2006

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Society for Gynecological Surgery in Finland

Collaborators

Helsinki University Central Hospital

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

December 1, 2006

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

August 28, 2008

First Submitted That Met QC Criteria

August 28, 2008

First Posted (Estimate)

August 29, 2008

Study Record Updates

Last Update Posted (Estimate)

November 18, 2014

Last Update Submitted That Met QC Criteria

November 17, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Finhyst 2006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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