CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 319 enrolled
Drug / intervention
Subtotal hysterectomy +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01880710
NCT01880710N/ACompleted

Randomized Clinical Trial of Total Versus Subtotal Abdominal Hysterectomy

Nykøbing Falster County Hospital·interventional·Posted Jun 19, 2013·Updated Sep 25, 2014

In Brief

A clinical study evaluating Subtotal hysterectomy and Total Hysterectomy for Benign Uterine Disease. Completed, enrolled 319 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesDenmark

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJun 19, 2013
Enrollment StartAug 1, 2012
Primary CompletionSep 1, 2013
Study CompletionFeb 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 13.0 years ago

Interventions

Subtotal hysterectomyprocedure

Subtotal abdominal hysterectomy where the body of the uterus is removed but the cervix is spared.

Total Hysterectomyprocedure

total abdominal hysterectomy where the body as well as the cervix of the uterus are removed.