Morbidity of HysterectomyFinhyst 2006NCT00744172
Finhyst 2006: Study on Morbidity of Hysterectomies in Finland
A study testing laparoscopy, vaginal and abdominal in people with Morbidity of Hysterectomy, run by Society for Gynecological Surgery in Finland at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Morbidity of Hysterectomy
- What is being tested?
- laparoscopy, vaginal and abdominal
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,279 participants
- Where
- 1 siteFinland
- Study dates
- Jan 2006to Dec 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Bening indications for hysterectomy
Who cannot join
- Malignant indications for hysterectomy
- Postpartum hysterectomy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Morbidity of Hysterectomy
- Being tested
- laparoscopy, vaginal, abdominal
- Keywords
- hysterectomy, vaginal, laparoscopy, abdominal, complication, quality of life, cost-effectiveness, Morbidity of three types of hysterectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopyProcedure or surgery
laparoscopic hysterectomy
vaginalProcedure or surgery
vaginal hysterectomy
abdominalProcedure or surgery
abdominal hysterectomy
| Study group | Role | What they receive |
|---|---|---|
| I | Active comparator | laparoscopy Receives: Procedure: laparoscopy |
| 2 | Active comparator | vaginal Receives: Procedure: vaginal |
| 3 | Active comparator | abdominal Receives: Procedure: abdominal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of hysterectomy
Measured: 1.1-31.12.2006
Secondary outcomes (1)
Cost-effectiveness
Measured: 1.1.-31.12.2006
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2008 (estimated)
- Study startJan 2006
- Primary completionDec 2006
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Morbidity of HysterectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5,279 participants (actual)
Sponsor and investigators
- Lead sponsor
- Society for Gynecological Surgery in Finland
- Sponsor type
- University, hospital or other
- Collaborators
- Helsinki University Central Hospital
- Responsible party
- Principal investigator, Paivi Harkki, Society for Gynecological Surgery in Finland
- Investigators
- Päivi SM Härkki, MD, Study director, Member of Society of Gynecological Surgery in Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00744172
- Sponsor's protocol ID
- Finhyst 2006
- Acronym
- Finhyst 2006
- Status last verified
- Nov 2014
- First submitted
- 28 Aug 2008
- Last updated
- 18 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kuittinen T, Tulokas S, Rahkola-Soisalo P, Brummer T, Harkki P, Mentula M. Patient-reported outcomes after hysterectomy due to pelvic organ prolapse versus other indications - a 10-year national follow-up study. BMC Womens Health. 2026 Feb 5;26(1):151. doi: 10.1186/s12905-026-04304-6.
PubMed 41639822Makinen 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.
PubMed 24165027Brummer 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.
PubMed 23786166Brummer 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.
PubMed 22422792
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Finhyst 2006: Incidence, Methods, Complications and Effect on Quality of Life of Hysterectomies in Finland in 2006
- ClinicalTrials.gov ID
- NCT00744172
- Acronym / sponsor ID
- Finhyst 2006 / Finhyst 2006
- Conditions
- Morbidity of Hysterectomy
- Keywords
- hysterectomy, vaginal, laparoscopy, abdominal, complication, quality of life, cost-effectiveness, Morbidity of three types of hysterectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,279 participants (actual)
- Lead sponsor
- Society for Gynecological Surgery in FinlandUniversity, hospital or other
- Collaborators
- Helsinki University Central Hospital
- Study start
- Jan 2006
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 29 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| I | Active comparator | Procedure: laparoscopylaparoscopy |
| 2 | Active comparator | Procedure: vaginalvaginal |
| 3 | Active comparator | Procedure: abdominalabdominal |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Bening indications for hysterectomy
Key exclusion criteria (2 listed)
- Malignant indications for hysterectomy
- Postpartum hysterectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| laparoscopylaparoscopic hysterectomy | Procedure or surgery | I |
| vaginalvaginal hysterectomy | Procedure or surgery | 2 |
| abdominalabdominal hysterectomy | Procedure or surgery | 3 |
Primary outcome
Safety of hysterectomy
Time frame: 1.1-31.12.2006
1 secondary outcome
Cost-effectiveness
Time frame: 1.1.-31.12.2006
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2014.
- Derived from this study: PubMed 41639822Kuittinen T, Tulokas S, Rahkola-Soisalo P, Brummer T, Harkki P, Mentula M. Patient-reported outcomes after hysterectomy due to pelvic organ prolapse versus other indications - a 10-year national follow-up study. BMC Womens Health. 2026 Feb 5;26(1):151. doi: 10.1186/s12905-026-04304-6.
- Derived from this study: PubMed 24165027Makinen 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.
- Derived from this study: PubMed 23786166Brummer 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.
- Derived from this study: PubMed 22422792Brummer 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Päivi SM Härkki, MD study director
Member of Society of Gynecological Surgery in Finland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laparoscopy, vaginal and abdominal in people with Morbidity of Hysterectomy, run by Society for Gynecological Surgery in Finland at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of hysterectomy (time frame: 1.1-31.12.2006). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00744172, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2014.