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Finhyst 2006: Study on Morbidity of Hysterectomies in Finland

NCT ID: NCT00744172

Last Updated: 2014-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

5279 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2010-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Morbidity of Hysterectomy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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I

laparoscopy

Group Type ACTIVE_COMPARATOR

laparoscopy

Intervention Type PROCEDURE

laparoscopic hysterectomy

2

vaginal

Group Type ACTIVE_COMPARATOR

vaginal

Intervention Type PROCEDURE

vaginal hysterectomy

3

abdominal

Group Type ACTIVE_COMPARATOR

abdominal

Intervention Type PROCEDURE

abdominal hysterectomy

Interventions

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laparoscopy

laparoscopic hysterectomy

Intervention Type PROCEDURE

vaginal

vaginal hysterectomy

Intervention Type PROCEDURE

abdominal

abdominal hysterectomy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Bening indications for hysterectomy

Exclusion Criteria

* Malignant indications for hysterectomy
* Postpartum hysterectomy
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Helsinki University Central Hospital

OTHER

Sponsor Role collaborator

Society for Gynecological Surgery in Finland

OTHER

Sponsor Role lead

Responsible Party

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Paivi Harkki

MD PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Päivi SM Härkki, MD

Role: STUDY_DIRECTOR

Member of Society of Gynecological Surgery in Finland

Locations

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Helsinki University Central Hospital

Helsinki, Helsinki, Finland

Site Status

Countries

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Finland

References

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Makinen J, Brummer T, Jalkanen J, Heikkinen AM, Fraser J, Tomas E, Harkki P, Sjoberg J. Ten years of progress--improved hysterectomy outcomes in Finland 1996-2006: a longitudinal observation study. BMJ Open. 2013 Oct 28;3(10):e003169. doi: 10.1136/bmjopen-2013-003169.

Reference Type DERIVED
PMID: 24165027 (View on PubMed)

Brummer TH, Heikkinen AM, Jalkanen J, Fraser J, Makinen J, Tomas E, Seppala T, Sjoberg J, Harkki P. Antibiotic prophylaxis for hysterectomy, a prospective cohort study: cefuroxime, metronidazole, or both? BJOG. 2013 Sep;120(10):1269-76. doi: 10.1111/1471-0528.12178. Epub 2013 Jun 21.

Reference Type DERIVED
PMID: 23786166 (View on PubMed)

Brummer TH, Heikkinen A, Jalkanen J, Fraser J, Makinen J, Tomas E, Seppala T, Sjoberg J, Harkki P. Pharmaceutical thrombosis prophylaxis, bleeding complications and thromboembolism in a national cohort of hysterectomy for benign disease. Hum Reprod. 2012 Jun;27(6):1628-36. doi: 10.1093/humrep/des103. Epub 2012 Mar 14.

Reference Type DERIVED
PMID: 22422792 (View on PubMed)

Other Identifiers

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Finhyst 2006

Identifier Type: -

Identifier Source: org_study_id