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.
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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
2 months, 6months, 1, 5 and 15 years postoperatively
Lea L Andersen, MD
Nykoebing Falster County Hospital
Denmark: Ethics Committee