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Total Versus Subtotal Abdominal Hysterectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01880710
Recruitment Status : Completed
First Posted : June 19, 2013
Last Update Posted : September 25, 2014
Information provided by (Responsible Party):

Study Description
Brief 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. 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.

Condition or disease Intervention/treatment
Benign Uterine Disease Procedure: Subtotal hysterectomy Procedure: Total Hysterectomy

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 319 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial of Total Versus Subtotal Abdominal Hysterectomy
Study Start Date : August 2012
Primary Completion Date : September 2013
Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Total hysterectomy
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.
Procedure: Total Hysterectomy
total abdominal hysterectomy where the body as well as the cervix of the uterus are removed.
Experimental: Subtotal Hysterectomy
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.
Procedure: Subtotal hysterectomy
Subtotal abdominal hysterectomy where the body of the uterus is removed but the cervix is spared.

Outcome Measures

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. pelvic organ prolapse [ Time Frame: preoperatively, 2 months, 6months, 1, 5 and 15 years postoperatively ]
    subjective measure by questionnaire at each time point as well as objective measure by POP-Q measurement at 15 years

  2. cervical problems in the SAH group [ Time Frame: preoperatively, 2 months, 6months, 1, 5 and 15 years postoperatively ]
    questionnaire regarding bleeding at each time point, pap-smear regarding dysplasia at 15 years discharge summaries from hospital admissions/contacts regarding cervical problems.

  3. voiding difficulties and LUTS (Lower Urinary Tract Symptoms) [ Time Frame: preoperatively, 2 months, 6 months, 1, 5 and 15 years postoperatively ]
    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.

Other Outcome Measures:
  1. quality of life [ Time Frame: preoperatively, 2 months, 6months, 1 and 15 years postoperatively ]
    SF-36 questionnaire at each time point

  2. sexuality [ Time Frame: preoperatively, 2 months, 6months, 1, 5 and 15 years postoperatively ]
    questionnaire at each time point

  3. pelvic pain [ Time Frame: preoperatively, 2 months, 6months, 1, 5 and 15 years postoperatively ]
    questionnaire at each time point

  4. bowel problems [ Time Frame: preoperatively, 2 months, 6months, 1, 5 and 15 years postoperatively ]
    questionnaire at each time point

  5. per- and postoperative complications [ Time Frame: preoperatively, 2 months, 6months, 1, 5 and 15 years postoperatively ]
    questionnaire at each time points and case records regarding related surgery (hernia, bowel obstruction, removal of the cervix, surgery for urinary incontinence and pelvic organ prolapse)looked up in the clinical registry

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

-Women undergoing abdominal hysterectomy for benign uterine disease at a gynaecological department in Denmark (15 years ago)

Exclusion Criteria:

  • 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01880710

Nykoebing Falster County Hospital
Nykoebing Falster, Region Sjaelland, Denmark, 4800
Sponsors and Collaborators
Nykøbing Falster County Hospital
University of Southern Denmark
University Hospital Roskilde
Rigshospitalet, Denmark
Principal Investigator: Lea L Andersen, MD Nykoebing Falster County Hospital
Study Director: Helga ME Gimbel, Dr.med.sci. University of Southern Denmark
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lea Laird Andersen, MD, PhD.-student, Nykøbing Falster County Hospital
ClinicalTrials.gov Identifier: NCT01880710     History of Changes
Other Study ID Numbers: sj-268
First Posted: June 19, 2013    Key Record Dates
Last Update Posted: September 25, 2014
Last Verified: September 2014

Keywords provided by Lea Laird Andersen, Nykøbing Falster County Hospital:
long term follow-up
urinary incontinence
pelvic organ prolapse
total versus subtotal hysterectomy

Additional relevant MeSH terms:
Uterine Diseases
Genital Diseases, Female