Abdominal Hysterectomy (& Wertheim)NCT02166749
Clinical Follow up After Subtotal and Total Hysterectomy
An observational study of Abdominal Hysterectomy (& Wertheim), run by Turku University Hospital at 1 site in Finland.
Trial summary
The purpose of this study was to find out subjective and objective outcomes of patients undergoing subtotal or total abdominal hysterectomy during a follow up of a mean 33 years after the operation. The hypothesis is that there are similar outcomes after both types of operations. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Abdominal Hysterectomy (& Wertheim)
- What is being tested?
- Subtotal abdominal hysterectomy
- Type of treatment
- Surgery or procedure
- How many people
- 212 participants
- Where
- 1 siteFinland
- Study dates
- Mar 1997to Dec 2011
- Phase
- Observational
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population included 212 patients operated on during February 1978 and May 1979 in Turku University Hospital. 107 women underwent subtotal and 105 women total abdominal hysterectomy.
Who may be able to join
- benign indication for hysterectomy
Who cannot join
- abnormal Pap smear
Trial locations and contacts
1 site in 1 country.
Finland1 site
Department of Obstetrics and Gynecology, Turku University Hospital
Turku, 20520
About this study
Official title: Ultra Long-term Follow-up of the Outcome After Subtotal Versus Total Abdominal Hysterectomy
The purpose of this study was to find out subjective and objective outcomes of patients undergoing subtotal or total abdominal hysterectomy during a follow up of a mean 33 years after the operation. The hypothesis is that there are similar outcomes after both types of operations.
Read the detailed description
Objective: To evaluate ultra long-term follow-up after subtotal and total hysterectomy in patients operated on during 1978-1979 in Turku University Hospital, Finland.
Methods: From the original cohort of 212 patients 193 were sent a postal questionnaire in 1997 to find out possible symptoms related to hysterectomy. Again in 2011 a questionnaire based evaluation with a possibility of a clinical visit to study hospital was done for 153 patients. In the first evaluation a self-made questionnaire and in the second evaluation validated questionnaires were used. During a follow-up visit a clinical examination using also POP-Q-system was done. Additionally, hospital records of the patients were reviewed to find out subsequent operations after hysterectomy.
- Conditions
- Abdominal Hysterectomy (& Wertheim)
- Being tested
- Subtotal abdominal hysterectomy
- Keywords
- Hysterectomy, long term follow up, subjective outcome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subtotal abdominal hysterectomyProcedure or surgery
Also called Total abdominal hysterectomy
Comparison of women undergoing subtotal abdominal hysterectomy (n=107) and women with total abdominal hysterectomy (n=105) a mean of 33 years ago.
| Study group | Role | What they receive |
|---|---|---|
| Subtotal abdominal hysterectomy | 107 women Receives: Procedure: Subtotal abdominal hysterectomy | |
| Total abdominal hysterectomy | 105 women Receives: Procedure: Subtotal abdominal hysterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants having subjective symptoms after hysterectomy
Urinary and bowel symptoms assessed with questionnaires and Visual Analog Scale.
Sexual symptoms assessed with questionnaire.
Measured: 19 years and 33 years postoperatively
Secondary outcomes (1)
Objective evaluation of pelvic organ prolapse after hysterectomy
Gynecological examination and measurements using pelvic organ prolapse quantification system (POP-Q) to find out the number of participants having prolapse.
Measured: 33 years postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2014 (estimated)
- Study startMar 1997
- Primary completionOct 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Abdominal Hysterectomy (& Wertheim)Studies of the same condition, open and under way.
- More trials run by Turku University HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 212 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Seija Ala-Nissilä, Turku University Hospital
- Investigators
- Juha Mäkinen, Professor, Study director, Turku University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02166749
- Sponsor's protocol ID
- ETMK:41/180/2010
- Status last verified
- Jun 2014
- First submitted
- 16 Jun 2014
- Last updated
- 30 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Ala-Nissila S, Haarala M, Jarvenpaa T, Makinen J. Long-term follow-up of the outcome of supracervical versus total abdominal hysterectomy. Int Urogynecol J. 2017 Feb;28(2):299-306. doi: 10.1007/s00192-016-3143-0. Epub 2016 Sep 17.
PubMed 27640066
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultra Long-term Follow-up of the Outcome After Subtotal Versus Total Abdominal Hysterectomy
- ClinicalTrials.gov ID
- NCT02166749
- Acronym / sponsor ID
- ETMK:41/180/2010
- Conditions
- Abdominal Hysterectomy (& Wertheim)
- Keywords
- Hysterectomy, long term follow up, subjective outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 212 participants (actual)
- Lead sponsor
- Turku University HospitalOther government
- Study start
- Mar 1997
- Primary completion
- Oct 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 18 Jun 2014 (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 was to find out subjective and objective outcomes of patients undergoing subtotal or total abdominal hysterectomy during a follow up of a mean 33 years after the operation. The hypothesis is that there are similar outcomes after both types of operations.
Detailed description
Objective: To evaluate ultra long-term follow-up after subtotal and total hysterectomy in patients operated on during 1978-1979 in Turku University Hospital, Finland.
Methods: From the original cohort of 212 patients 193 were sent a postal questionnaire in 1997 to find out possible symptoms related to hysterectomy. Again in 2011 a questionnaire based evaluation with a possibility of a clinical visit to study hospital was done for 153 patients. In the first evaluation a self-made questionnaire and in the second evaluation validated questionnaires were used. During a follow-up visit a clinical examination using also POP-Q-system was done. Additionally, hospital records of the patients were reviewed to find out subsequent operations after hysterectomy.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subtotal abdominal hysterectomy | – | Procedure: Subtotal abdominal hysterectomy107 women |
| Total abdominal hysterectomy | – | Procedure: Subtotal abdominal hysterectomy105 women |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population included 212 patients operated on during February 1978 and May 1979 in Turku University Hospital. 107 women underwent subtotal and 105 women total abdominal hysterectomy.
Key inclusion criteria (1 listed)
- benign indication for hysterectomy
Key exclusion criteria (1 listed)
- abnormal Pap smear
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 |
|---|---|---|
| Subtotal abdominal hysterectomyAlso: Total abdominal hysterectomyComparison of women undergoing subtotal abdominal hysterectomy (n=107) and women with total abdominal hysterectomy (n=105) a mean of 33 years ago. | Procedure or surgery | Subtotal abdominal hysterectomy, Total abdominal hysterectomy |
Primary outcome
Number of participants having subjective symptoms after hysterectomy
Time frame: 19 years and 33 years postoperatively
Urinary and bowel symptoms assessed with questionnaires and Visual Analog Scale. Sexual symptoms assessed with questionnaire.
1 secondary outcome
Objective evaluation of pelvic organ prolapse after hysterectomy
Time frame: 33 years postoperatively
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 30 Jun 2014.
- Derived from this study: PubMed 27640066Ala-Nissila S, Haarala M, Jarvenpaa T, Makinen J. Long-term follow-up of the outcome of supracervical versus total abdominal hysterectomy. Int Urogynecol J. 2017 Feb;28(2):299-306. doi: 10.1007/s00192-016-3143-0. Epub 2016 Sep 17.
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.
Juha Mäkinen, Professor study director
Turku University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Hysterectomy (& Wertheim), run by Turku University Hospital 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 1 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 30 Jun 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?
Number of participants having subjective symptoms after hysterectomy (time frame: 19 years and 33 years postoperatively). 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 NCT02166749, which also lists 1 linked publication.
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 30 Jun 2014.