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Randomized Clinical Trial of Total Versus Subtotal Abdominal Hysterectomy

18 Years
Open (Enrolling by invite only)
Benign Uterine Disease

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Trial Information

Randomized Clinical Trial of Total Versus Subtotal Abdominal Hysterectomy

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

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.

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

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

change in Urinary incontinence from baseline (preoperatively)

Outcome Description:

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

Outcome Time Frame:

2 months, 6months, 1, 5 and 15 years postoperatively

Safety Issue:


Principal Investigator

Lea L Andersen, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Nykoebing Falster County Hospital


Denmark: Ethics Committee

Study ID:




Start Date:

August 2012

Completion Date:

December 2013

Related Keywords:

  • Benign Uterine Disease
  • long term follow-up
  • urinary incontinence
  • pelvic organ prolapse
  • total versus subtotal hysterectomy
  • Uterine Diseases