NCT00744172

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,279

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

August 28, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 29, 2008

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

November 18, 2014

Status Verified

November 1, 2014

Enrollment Period

11 months

First QC Date

August 28, 2008

Last Update Submit

November 17, 2014

Conditions

Morbidity of Hysterectomy

Keywords

hysterectomyvaginallaparoscopyabdominalcomplicationquality of lifecost-effectivenessMorbidity of three types of hysterectomy

Outcome Measures

Primary Outcomes (1)

  • Safety of hysterectomy

    1.1-31.12.2006

Secondary Outcomes (1)

  • Cost-effectiveness

    1.1.-31.12.2006

Study Arms (3)

I

ACTIVE COMPARATOR

laparoscopy

Procedure: laparoscopy

2

ACTIVE COMPARATOR

vaginal

Procedure: vaginal

3

ACTIVE COMPARATOR

abdominal

Procedure: abdominal

Interventions

laparoscopyPROCEDURE

laparoscopic hysterectomy

I
vaginalPROCEDURE

vaginal hysterectomy

2
abdominalPROCEDURE

abdominal hysterectomy

3

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Bening indications for hysterectomy

You may not qualify if:

  • Malignant indications for hysterectomy
  • Postpartum hysterectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helsinki University Central Hospital

Helsinki, Helsinki, 00029, Finland

Location

Related Publications (3)

  • 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.

    PMID: 24165027DERIVED

  • 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.

    PMID: 23786166DERIVED

  • 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.

    PMID: 22422792DERIVED

MeSH Terms

Interventions

Laparoscopy

Intervention Hierarchy (Ancestors)

EndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Päivi SM Härkki, MD

    Member of Society of Gynecological Surgery in Finland

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

August 28, 2008

First Posted

August 29, 2008

Study Start

January 1, 2006

Primary Completion

December 1, 2006

Study Completion

December 1, 2010

Last Updated

November 18, 2014

Record last verified: 2014-11

Locations

FI(1)