HysterectomyPhase 4NCT00876057
Psychological Well-being, Recovery and Sexuality After Total and Subtotal Hysterectomy
A Phase 4 study testing Total abdominal hysterectomy and Subtotal abdominal hysterectomy in people with Hysterectomy, run by University Hospital, Linkoeping at 7 sites in Sweden.
Trial summary
The purpose of this study is to determine whether psychological well-being, recovery and sexuality differs in women undergoing subtotal and total abdominal hysterectomy. Se also Detailed Description for additional study. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hysterectomy
- What is being tested?
- Total abdominal hysterectomy and Subtotal abdominal hysterectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 7 sitesSweden
- Study dates
- Mar 1998to Apr 2005
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primarily uterine fibroids with bleeding disturbance or mechanical symptoms but other benign disorders were hysterectomy was recommended were also eligible
- After surgery at least one ovary preserved.
- Informed verbal and written consent
- Proficiency in Swedish
Who cannot join
- Malignancy in the genital organs.
- Previous or present cervical dysplasia.
- Rapidly growing fibroids where malignancy could not be ruled out
- Preoperative treatment with GnRH analogues.
- Postmenopausal women without hormone therapy
- Severe psychiatric disorder
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Sweden7 sites
Höglandssjukhuset i Eksjö
Eksjö, 57581
Ryhov Central Hospital
Jönköping, 55185
County Hospital in Kalmar
Kalmar, 39185
Motala Counbty Hospital
Motala, 59185
Vrinnevi Hospital
Norrköping, 601 82
Capio Läkargruppen
Örebro, 70146
Värnamo County Hospital
Värnamo, 33185
About this study
Official title: Subtotal Versus Total Abdominal Hysterectomy- a Prospective Randomised Comparison of Medical , Psychological and Sexual Effects.
The purpose of this study is to determine whether psychological well-being, recovery and sexuality differs in women undergoing subtotal and total abdominal hysterectomy.
Se also Detailed Description for additional study.
Read the detailed description
An additional study study based on the material in original study started in april 2011. The purpose of this study is to investigate the development of pelvis organ prolapse in the long term (median eleven years after hysterectomy and by questionnaires, Pelvic-floor Distress Inventory SF-20 analyze if patient reported symptoms regarding urinary-and bowels functions differs regarding the method of hysterectomy.
- Conditions
- Hysterectomy
- Being tested
- Total abdominal hysterectomy, Subtotal abdominal hysterectomy
- Keywords
- psychological well-being, recovery, time in hospital, sick-leave, complications, Sexual well-being
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total abdominal hysterectomyProcedure or surgery
Total abdominal hysterectomy
Subtotal abdominal hysterectomyProcedure or surgery
Subtotal abdominal hysterectomy
| Study group | Role | What they receive |
|---|---|---|
| TH | Active comparator | Total hysterectomy Receives: Procedure: Total abdominal hysterectomy |
| SH | Active comparator | Subtotal hysterectomy Receives: Procedure: Subtotal abdominal hysterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychological well-being
Measured: One year after surgery
Secondary outcomes (4)
Recovery of general well-being
Measured: Five weeks after surgery
Sexuality
Measured: One year
Pelvic organ prolapse (anatomical)
Follow-up median eleven years after the initial hysterectomy. Clinical investigation including POP-Q.
Measured: 7-14 years
Patient reported symptoms of pelvic organ dysfunction
Follow-up median eleven years after the initial hysterectomy. Questionnaire (Pelvic Floor Dysfuntion Inventoy).
Measured: 7-14 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2009 (estimated)
- Study startMar 1998
- Primary completionApr 2004
- Study completionApr 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Linkoeping
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Preben Kjolhede, University Hospital, Linkoeping
- Investigators
- Preben Kjölhede, MD, PhD, Study chair, University Hospital, LinköpingPär Persson, MD, Study director, University Hospital, Linköping
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00876057
- Sponsor's protocol ID
- 2009-0102
- Status last verified
- Jun 2012
- First submitted
- 3 Apr 2009
- Last updated
- 11 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subtotal Versus Total Abdominal Hysterectomy- a Prospective Randomised Comparison of Medical , Psychological and Sexual Effects.
- ClinicalTrials.gov ID
- NCT00876057
- Acronym / sponsor ID
- 2009-0102
- Conditions
- Hysterectomy
- Keywords
- psychological well-being, recovery, time in hospital, sick-leave, complications, Sexual well-being
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University Hospital, LinkoepingUniversity, hospital or other
- Study start
- Mar 1998
- Primary completion
- Apr 2004 (actual)
- Study completion
- Apr 2005 (actual)
- First posted
- 6 Apr 2009 (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 determine whether psychological well-being, recovery and sexuality differs in women undergoing subtotal and total abdominal hysterectomy.
Se also Detailed Description for additional study.
Detailed description
An additional study study based on the material in original study started in april 2011. The purpose of this study is to investigate the development of pelvis organ prolapse in the long term (median eleven years after hysterectomy and by questionnaires, Pelvic-floor Distress Inventory SF-20 analyze if patient reported symptoms regarding urinary-and bowels functions differs regarding the method of hysterectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TH | Active comparator | Procedure: Total abdominal hysterectomyTotal hysterectomy |
| SH | Active comparator | Procedure: Subtotal abdominal hysterectomySubtotal hysterectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Primarily uterine fibroids with bleeding disturbance or mechanical symptoms but other benign disorders were hysterectomy was recommended were also eligible
- After surgery at least one ovary preserved.
- Informed verbal and written consent
- Proficiency in Swedish
Key exclusion criteria (6 listed)
- Malignancy in the genital organs.
- Previous or present cervical dysplasia.
- Rapidly growing fibroids where malignancy could not be ruled out
- Preoperative treatment with GnRH analogues.
- Postmenopausal women without hormone therapy
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 |
|---|---|---|
| Total abdominal hysterectomyTotal abdominal hysterectomy | Procedure or surgery | TH |
| Subtotal abdominal hysterectomySubtotal abdominal hysterectomy | Procedure or surgery | SH |
Primary outcome
Psychological well-being
Time frame: One year after surgery
4 secondary outcomes
Recovery of general well-being
Time frame: Five weeks after surgery
Sexuality
Time frame: One year
Pelvic organ prolapse (anatomical)
Time frame: 7-14 years
Patient reported symptoms of pelvic organ dysfunction
Time frame: 7-14 years
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 11 Jun 2012.
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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.
Preben Kjölhede, MD, PhD study chair
University Hospital, Linköping
Pär Persson, MD study director
University Hospital, Linköping
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Total abdominal hysterectomy and Subtotal abdominal hysterectomy in people with Hysterectomy, run by University Hospital, Linkoeping at 7 sites in Sweden.
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 4 inclusion and 6 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 11 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Sweden. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Psychological well-being (time frame: One year after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jun 2012.