Total Versus Subtotal Abdominal Hysterectomy
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|ClinicalTrials.gov Identifier: NCT01880710|
Recruitment Status : Completed
First Posted : June 19, 2013
Last Update Posted : September 25, 2014
|Condition or disease||Intervention/treatment||Phase|
|Benign Uterine Disease||Procedure: Subtotal hysterectomy Procedure: Total Hysterectomy||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||319 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Clinical Trial of Total Versus Subtotal Abdominal Hysterectomy|
|Study Start Date :||August 2012|
|Actual Primary Completion Date :||September 2013|
|Actual Study Completion Date :||February 2014|
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.
- 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
- 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
- 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.
- 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.
- quality of life [ Time Frame: preoperatively, 2 months, 6months, 1 and 15 years postoperatively ]SF-36 questionnaire at each time point
- sexuality [ Time Frame: preoperatively, 2 months, 6months, 1, 5 and 15 years postoperatively ]questionnaire at each time point
- pelvic pain [ Time Frame: preoperatively, 2 months, 6months, 1, 5 and 15 years postoperatively ]questionnaire at each time point
- bowel problems [ Time Frame: preoperatively, 2 months, 6months, 1, 5 and 15 years postoperatively ]questionnaire at each time point
- 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
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|
|Principal Investigator:||Lea L Andersen, MD||Nykoebing Falster County Hospital|
|Study Director:||Helga ME Gimbel, Dr.med.sci.||University of Southern Denmark|