An interventional study of Subtotal hysterectomy and Total Hysterectomy in Benign Uterine Disease, sponsored by Nykøbing Falster County Hospital. Completed at 1 site in Denmark. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-09-25.
Sponsored by Nykøbing Falster County Hospital · Not applicable, Interventional, and Treatment
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.
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.
66 studies on the registry are indexed under Uterine Diseases; 8 are open to participants now.
This study's enrollment of 319 is above the median of 98 across 52 interventional studies indexed under Uterine Diseases.
Browse Uterine Diseases studies →Nykøbing Falster County Hospital is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
-Women undergoing abdominal hysterectomy for benign uterine disease at a gynaecological department in Denmark (15 years ago)
Exclusion Criteria:
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
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.
total abdominal hysterectomy where the body as well as the cervix of the uterus are removed.
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
Time frame: 2 months, 6months, 1, 5 and 15 years postoperatively
pelvic organ prolapse
subjective measure by questionnaire at each time point as well as objective measure by POP-Q measurement at 15 years
Time frame: 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.
Time frame: 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.
Time frame: preoperatively, 2 months, 6 months, 1, 5 and 15 years postoperatively
quality of life
SF-36 questionnaire at each time point
Time frame: preoperatively, 2 months, 6months, 1 and 15 years postoperatively
sexuality
questionnaire at each time point
Time frame: preoperatively, 2 months, 6months, 1, 5 and 15 years postoperatively
pelvic pain
questionnaire at each time point
Time frame: preoperatively, 2 months, 6months, 1, 5 and 15 years postoperatively
bowel problems
questionnaire at each time point
Time frame: preoperatively, 2 months, 6months, 1, 5 and 15 years postoperatively
per- and postoperative complications
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
Time frame: preoperatively, 2 months, 6months, 1, 5 and 15 years postoperatively
This study is completed, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.
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Nykøbing Falster County Hospital