Benign Uterine DiseaseNCT01880710
Total Versus Subtotal Abdominal Hysterectomy
A study testing Subtotal hysterectomy and Total Hysterectomy in people with Benign Uterine Disease, run by Nykøbing Falster County Hospital at 1 site in Denmark.
Trial summary
319 Women undergoing hysterectomy for benign (not cancer) indications were randomly allocated to 2 types of surgery (Total (TAH) and Subtotal (SAH)) abdominal hysterectomy 15 years ago. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Benign Uterine Disease
- What is being tested?
- Subtotal hysterectomy and Total Hysterectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 319 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2012to Feb 2014
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -Women undergoing abdominal hysterectomy for benign uterine disease at a gynaecological department in Denmark (15 years ago)
Who cannot join
- malignant disease
- mental disease
- diabetes
- neurological disease
- not able to read and write Danish
- pelvic organ prolapse as the reason for hysterectomy
- prior surgery for urinary incontinence
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Nykoebing Falster County Hospital
Nykoebing Falster, Region Sjælland, 4800
About this study
Official title: Randomized Clinical Trial of Total Versus Subtotal Abdominal Hysterectomy
319 Women undergoing hysterectomy for benign (not cancer) indications were randomly allocated to 2 types of surgery (Total (TAH) and Subtotal (SAH)) abdominal hysterectomy 15 years ago. They were followed by questionnaire at time of surgery and up to 5 years (not yet published) after the surgery and evaluated regarding following outcomes: Urinary incontinence, pain, bowel problems, per and postoperative complications, sexuality, quality of life, pelvic organ prolapse and vaginal bleeding. Now the investigators are conducting a 15 year follow up with the same out-come measures but also including physical examinations regarding Urinary incontinence, voiding difficulties, pelvic organ prolapse and problems with the cervix. The investigators' hypothesis is that several of the out-come measures will be present in more cases than earlier due to age and menopausal changes. The investigators expect more urinary incontinence in the subtotal group as this was seen at earlier follow ups. The investigators expect to find more women with pelvic organ prolapse with the physical examination than by questionnaire alone, possibly with a higher incidence in the subtotal group.
Read the detailed description
The study included women who were offered a hysterectomy for benign uterine disease such as: metrorrhagia, menorrhagia, fibroids, endometriosis,and pelvic pain. Women in need of hysterectomy for malignant disease or because of prolapse of the uterus were not included. They were followed up by a questionnaire covering all outcome measures as described above. Background information was registered in a second questionnaire prior to surgery. All gynaecological departments in Denmark were invited to join the trial. 11 departments contributed randomized patients to the trial.
the results up to 1 year after surgery have been published, links can be found in the citation list. The results from the 5 year follow up have not yet been published.
The questionnaire used in this trial consists of the validated SF-36 (Short Form 36) quality of life questionnaire as well as a thorough questionnaire regarding the outcome measures described elsewhere. The entire questionnaire was validated prior to the beginning of the trial.
A second questionnaire has been added in the 15 year follow up: PFDI-20(Pelvic Floor Distress Inventory 20). The investigators included this, as it is more thorough regarding pelvic organ prolapse and in particular a "bother" measure than the original questionnaire.
The 20 min. pad-weighing test has been tested against the 1 hour gold-standard used by the ICS (International Continence Society) and has been found to give comparable results.
- Conditions
- Benign Uterine Disease
- Being tested
- Subtotal hysterectomy, Total Hysterectomy
- Keywords
- long term follow-up, urinary incontinence, pelvic organ prolapse, total versus subtotal hysterectomy
- Medical subject headings
- Urinary Incontinence, Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subtotal hysterectomyProcedure or surgery
Subtotal abdominal hysterectomy where the body of the uterus is removed but the cervix is spared.
Total HysterectomyProcedure or surgery
total abdominal hysterectomy where the body as well as the cervix of the uterus are removed.
| Study group | Role | What they receive |
|---|---|---|
| Total hysterectomy | Active comparator | removal of the entire uterus including the cervix. open abdominal surgery. No specific procedures were asked of the surgeon. They were free to do the procedure the way they were used to doing it. Receives: Procedure: Total Hysterectomy |
| Subtotal Hysterectomy | Experimental | removal of the uterine body only leaving the cervix in situ. The surgeon was free to do the procedure as he was used to. The only direction was that the cervical canal should be electrocoagulated. Receives: Procedure: Subtotal hysterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in Urinary incontinence from baseline (preoperatively)
urinary incontinence measured by questionnaire filled out by the participants at each time point as well as a more objective measure: pad weighing test and voiding diary at 15 years
Measured: 2 months, 6months, 1, 5 and 15 years postoperatively
Secondary outcomes (3)
pelvic organ prolapse
subjective measure by questionnaire at each time point as well as objective measure by POP-Q measurement at 15 years
Measured: preoperatively, 2 months, 6months, 1, 5 and 15 years postoperatively
cervical problems in the SAH group
questionnaire regarding bleeding at each time point, pap-smear regarding dysplasia at 15 years discharge summaries from hospital admissions/contacts regarding cervical problems.
Measured: preoperatively, 2 months, 6months, 1, 5 and 15 years postoperatively
voiding difficulties and LUTS (Lower Urinary Tract Symptoms)
covered by the questionnaire at each time point regarding urinary tract infections and problems emptying the bladder. In addition the 15 year follow up consists of uroflow, dip-stick for urinary infection as well as post-voiding ultrasound of the bladder to detect urinary retention.
Measured: preoperatively, 2 months, 6 months, 1, 5 and 15 years postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2013 (estimated)
- Study startAug 2012
- Primary completionSep 2013
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Benign Uterine DiseaseStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 319 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nykøbing Falster County Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern Denmark, Zealand University Hospital, Copenhagen University Hospital, Rigshospitalet
- Responsible party
- Principal investigator, Lea Laird Andersen, Nykøbing Falster County Hospital
- Investigators
- Lea L Andersen, MD, Principal investigator, Nykoebing Falster County HospitalHelga ME Gimbel, Dr.med.sci., Study director, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01880710
- Sponsor's protocol ID
- sj-268
- Status last verified
- Sep 2014
- First submitted
- 14 May 2013
- Last updated
- 25 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Gimbel H, Zobbe V, Ottesen BS, Tabor A. Randomized clinical trial of total vs. subtotal hysterectomy: validity of the trial questionnaire. Acta Obstet Gynecol Scand. 2002 Oct;81(10):968-74. doi: 10.1034/j.1600-0412.2002.811012.x.
PubMed 12366489Gimbel H, Zobbe V, Andersen BJ, Sorensen HC, Toftager-Larsen K, Sidenius K, Moller N, Madsen EM, Vejtorp M, Clausen H, Rosgaard A, Villumsen J, Gluud C, Ottesen BS, Tabor A. Lower urinary tract symptoms after total and subtotal hysterectomy: results of a randomized controlled trial. Int Urogynecol J Pelvic Floor Dysfunct. 2005 Jul-Aug;16(4):257-62. doi: 10.1007/s00192-005-1291-8.
PubMed 16220584Gimbel H, Zobbe V, Andersen BM, Filtenborg T, Gluud C, Tabor A. Randomised controlled trial of total compared with subtotal hysterectomy with one-year follow up results. BJOG. 2003 Dec;110(12):1088-98.
PubMed 14664880Zobbe V, Gimbel H, Andersen BM, Filtenborg T, Jakobsen K, Sorensen HC, Toftager-Larsen K, Sidenius K, Moller N, Madsen EM, Vejtorp M, Clausen H, Rosgaard A, Gluud C, Ottesen BS, Tabor A. Sexuality after total vs. subtotal hysterectomy. Acta Obstet Gynecol Scand. 2004 Feb;83(2):191-6. doi: 10.1111/j.0001-6349.2004.00311.x.
PubMed 14756739Andersen LL, Moller LM, Gimbel HM. Low adherence to cervical cancer screening after subtotal hysterectomy. Dan Med J. 2015 Dec;62(12):A5165.
PubMed 26621394Andersen LL, Alling Moller LM, Gimbel HM. Objective comparison of subtotal vs. total abdominal hysterectomy regarding pelvic organ prolapse and urinary incontinence: a randomized controlled trial with 14-year follow-up. Eur J Obstet Gynecol Reprod Biol. 2015 Oct;193:40-5. doi: 10.1016/j.ejogrb.2015.06.033. Epub 2015 Jul 9.
PubMed 26231437Andersen LL, Moller LM, Gimbel H; Danish Hysterectomy Trial Group. Lower urinary tract symptoms after subtotal versus total abdominal hysterectomy: exploratory analyses from a randomized clinical trial with a 14-year follow-up. Int Urogynecol J. 2015 Dec;26(12):1767-72. doi: 10.1007/s00192-015-2778-6. Epub 2015 Jul 28.
PubMed 26215904Andersen LL, Zobbe V, Ottesen B, Gluud C, Tabor A, Gimbel H; Danish Hysterectomy Trial Group. Five-year follow up of a randomised controlled trial comparing subtotal with total abdominal hysterectomy. BJOG. 2015 May;122(6):851-857. doi: 10.1111/1471-0528.12914. Epub 2014 Jun 11.
PubMed 24917531
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial of Total Versus Subtotal Abdominal Hysterectomy
- ClinicalTrials.gov ID
- NCT01880710
- Acronym / sponsor ID
- sj-268
- Conditions
- Benign Uterine Disease
- Keywords
- long term follow-up, urinary incontinence, pelvic organ prolapse, total versus subtotal hysterectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 319 participants (actual)
- Lead sponsor
- Nykøbing Falster County HospitalUniversity, hospital or other
- Collaborators
- University of Southern Denmark, Zealand University Hospital, Copenhagen University Hospital, Rigshospitalet
- Study start
- Aug 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 19 Jun 2013 (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.
319 Women undergoing hysterectomy for benign (not cancer) indications were randomly allocated to 2 types of surgery (Total (TAH) and Subtotal (SAH)) abdominal hysterectomy 15 years ago. They were followed by questionnaire at time of surgery and up to 5 years (not yet published) after the surgery and evaluated regarding following outcomes: Urinary incontinence, pain, bowel problems, per and postoperative complications, sexuality, quality of life, pelvic organ prolapse and vaginal bleeding. Now the investigators are conducting a 15 year follow up with the same out-come measures but also including physical examinations regarding Urinary incontinence, voiding difficulties, pelvic organ prolapse and problems with the cervix. The investigators' hypothesis is that several of the out-come measures will be present in more cases than earlier due to age and menopausal changes. The investigators expect more urinary incontinence in the subtotal group as this was seen at earlier follow ups. The investigators expect to find more women with pelvic organ prolapse with the physical examination than by questionnaire alone, possibly with a higher incidence in the subtotal group.
Detailed description
The study included women who were offered a hysterectomy for benign uterine disease such as: metrorrhagia, menorrhagia, fibroids, endometriosis,and pelvic pain. Women in need of hysterectomy for malignant disease or because of prolapse of the uterus were not included. They were followed up by a questionnaire covering all outcome measures as described above. Background information was registered in a second questionnaire prior to surgery. All gynaecological departments in Denmark were invited to join the trial. 11 departments contributed randomized patients to the trial.
the results up to 1 year after surgery have been published, links can be found in the citation list. The results from the 5 year follow up have not yet been published.
The questionnaire used in this trial consists of the validated SF-36 (Short Form 36) quality of life questionnaire as well as a thorough questionnaire regarding the outcome measures described elsewhere. The entire questionnaire was validated prior to the beginning of the trial.
A second questionnaire has been added in the 15 year follow up: PFDI-20(Pelvic Floor Distress Inventory 20). The investigators included this, as it is more thorough regarding pelvic organ prolapse and in particular a "bother" measure than the original questionnaire.
The 20 min. pad-weighing test has been tested against the 1 hour gold-standard used by the ICS (International Continence Society) and has been found to give comparable results.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Total hysterectomy | Active comparator | Procedure: Total Hysterectomyremoval of the entire uterus including the cervix. open abdominal surgery. No specific procedures were asked of the surgeon. They were free to do the procedure the way they were used to doing it. |
| Subtotal Hysterectomy | Experimental | Procedure: Subtotal hysterectomyremoval of the uterine body only leaving the cervix in situ. The surgeon was free to do the procedure as he was used to. The only direction was that the cervical canal should be electrocoagulated. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -Women undergoing abdominal hysterectomy for benign uterine disease at a gynaecological department in Denmark (15 years ago)
Key exclusion criteria (7 listed)
- malignant disease
- mental disease
- diabetes
- neurological disease
- not able to read and write Danish
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 hysterectomySubtotal abdominal hysterectomy where the body of the uterus is removed but the cervix is spared. | Procedure or surgery | Subtotal Hysterectomy |
| Total Hysterectomytotal abdominal hysterectomy where the body as well as the cervix of the uterus are removed. | Procedure or surgery | Total hysterectomy |
Primary outcome
change in Urinary incontinence from baseline (preoperatively)
Time frame: 2 months, 6months, 1, 5 and 15 years postoperatively
urinary incontinence measured by questionnaire filled out by the participants at each time point as well as a more objective measure: pad weighing test and voiding diary at 15 years
3 secondary outcomes
pelvic organ prolapse
Time frame: preoperatively, 2 months, 6months, 1, 5 and 15 years postoperatively
cervical problems in the SAH group
Time frame: preoperatively, 2 months, 6months, 1, 5 and 15 years postoperatively
voiding difficulties and LUTS (Lower Urinary Tract Symptoms)
Time frame: preoperatively, 2 months, 6 months, 1, 5 and 15 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 25 Sep 2014.
- Background: PubMed 12366489Gimbel H, Zobbe V, Ottesen BS, Tabor A. Randomized clinical trial of total vs. subtotal hysterectomy: validity of the trial questionnaire. Acta Obstet Gynecol Scand. 2002 Oct;81(10):968-74. doi: 10.1034/j.1600-0412.2002.811012.x.
- Results publication: PubMed 16220584Gimbel H, Zobbe V, Andersen BJ, Sorensen HC, Toftager-Larsen K, Sidenius K, Moller N, Madsen EM, Vejtorp M, Clausen H, Rosgaard A, Villumsen J, Gluud C, Ottesen BS, Tabor A. Lower urinary tract symptoms after total and subtotal hysterectomy: results of a randomized controlled trial. Int Urogynecol J Pelvic Floor Dysfunct. 2005 Jul-Aug;16(4):257-62. doi: 10.1007/s00192-005-1291-8.
- Results publication: PubMed 14664880Gimbel H, Zobbe V, Andersen BM, Filtenborg T, Gluud C, Tabor A. Randomised controlled trial of total compared with subtotal hysterectomy with one-year follow up results. BJOG. 2003 Dec;110(12):1088-98.
- Results publication: PubMed 14756739Zobbe V, Gimbel H, Andersen BM, Filtenborg T, Jakobsen K, Sorensen HC, Toftager-Larsen K, Sidenius K, Moller N, Madsen EM, Vejtorp M, Clausen H, Rosgaard A, Gluud C, Ottesen BS, Tabor A. Sexuality after total vs. subtotal hysterectomy. Acta Obstet Gynecol Scand. 2004 Feb;83(2):191-6. doi: 10.1111/j.0001-6349.2004.00311.x.
- Derived from this study: PubMed 26621394Andersen LL, Moller LM, Gimbel HM. Low adherence to cervical cancer screening after subtotal hysterectomy. Dan Med J. 2015 Dec;62(12):A5165.
- Derived from this study: PubMed 26231437Andersen LL, Alling Moller LM, Gimbel HM. Objective comparison of subtotal vs. total abdominal hysterectomy regarding pelvic organ prolapse and urinary incontinence: a randomized controlled trial with 14-year follow-up. Eur J Obstet Gynecol Reprod Biol. 2015 Oct;193:40-5. doi: 10.1016/j.ejogrb.2015.06.033. Epub 2015 Jul 9.
- Derived from this study: PubMed 26215904Andersen LL, Moller LM, Gimbel H; Danish Hysterectomy Trial Group. Lower urinary tract symptoms after subtotal versus total abdominal hysterectomy: exploratory analyses from a randomized clinical trial with a 14-year follow-up. Int Urogynecol J. 2015 Dec;26(12):1767-72. doi: 10.1007/s00192-015-2778-6. Epub 2015 Jul 28.
- Derived from this study: PubMed 24917531Andersen LL, Zobbe V, Ottesen B, Gluud C, Tabor A, Gimbel H; Danish Hysterectomy Trial Group. Five-year follow up of a randomised controlled trial comparing subtotal with total abdominal hysterectomy. BJOG. 2015 May;122(6):851-857. doi: 10.1111/1471-0528.12914. Epub 2014 Jun 11.
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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.
Lea L Andersen, MD principal investigator
Nykoebing Falster County Hospital
Helga ME Gimbel, Dr.med.sci. study director
University of Southern Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Subtotal hysterectomy and Total Hysterectomy in people with Benign Uterine Disease, run by Nykøbing Falster County Hospital at 1 site in Denmark.
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 7 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 25 Sep 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 Denmark. 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?
change in Urinary incontinence from baseline (preoperatively) (time frame: 2 months, 6months, 1, 5 and 15 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 NCT01880710, which also lists 8 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 25 Sep 2014; AzTrials last refreshed its copy on 28 Oct 2026.