Total Versus Subtotal Abdominal Hysterectomy
NCT01880710 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 319
Last updated 2014-09-25
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.
Conditions
- Benign Uterine Disease
Interventions
- PROCEDURE
-
Subtotal hysterectomy
Subtotal abdominal hysterectomy where the body of the uterus is removed but the cervix is spared.
- PROCEDURE
-
Total Hysterectomy
total abdominal hysterectomy where the body as well as the cervix of the uterus are removed.
Sponsors & Collaborators
-
University of Southern Denmark
collaborator OTHER -
Zealand University Hospital
collaborator OTHER -
Rigshospitalet, Denmark
collaborator OTHER -
Nykøbing Falster County Hospital
lead OTHER
Principal Investigators
-
Lea L Andersen, MD · Nykoebing Falster County Hospital
-
Helga ME Gimbel, Dr.med.sci. · University of Southern Denmark
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-08-31
- Primary Completion
- 2013-09-30
- Completion
- 2014-02-28
Countries
- Denmark
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