Trial record 2 of 947 for:    Uterine Diseases: Clinical Trials

Total Versus Subtotal Abdominal Hysterectomy

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
University of Southern Denmark
University Hospital Roskilde
Rigshospitalet, Denmark
Information provided by (Responsible Party):
Lea Laird Andersen, Nykøbing Falster County Hospital
ClinicalTrials.gov Identifier:
NCT01880710
First received: May 14, 2013
Last updated: June 14, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Benign Uterine Disease
Procedure: Subtotal hysterectomy
Procedure: Total Hysterectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial of Total Versus Subtotal Abdominal Hysterectomy

Resource links provided by NLM:


Further study details as provided by Nykøbing Falster County Hospital:

Primary Outcome Measures:
  • change in Urinary incontinence from baseline (preoperatively) [ Time Frame: 2 months, 6months, 1, 5 and 15 years postoperatively ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • pelvic organ prolapse [ Time Frame: preoperatively, 2 months, 6months, 1, 5 and 15 years postoperatively ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • quality of life [ Time Frame: preoperatively, 2 months, 6months, 1 and 15 years postoperatively ] [ Designated as safety issue: No ]
    SF-36 questionnaire at each time point

  • sexuality [ Time Frame: preoperatively, 2 months, 6months, 1, 5 and 15 years postoperatively ] [ Designated as safety issue: No ]
    questionnaire at each time point

  • pelvic pain [ Time Frame: preoperatively, 2 months, 6months, 1, 5 and 15 years postoperatively ] [ Designated as safety issue: No ]
    questionnaire at each time point

  • bowel problems [ Time Frame: preoperatively, 2 months, 6months, 1, 5 and 15 years postoperatively ] [ Designated as safety issue: No ]
    questionnaire at each time point

  • per- and postoperative complications [ Time Frame: preoperatively, 2 months, 6months, 1, 5 and 15 years postoperatively ] [ Designated as safety issue: No ]
    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


Enrollment: 319
Study Start Date: August 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

-Women undergoing abdominal hysterectomy for benign uterine disease at a gynaecological department in Denmark (15 years ago)

Exclusion Criteria:

  • malignant disease
  • mental disease
  • diabetes
  • neurological disease
  • not able to read and write Danish
  • pelvic organ prolapse as the reason for hysterectomy
  • prior surgery for urinary incontinence
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01880710

Locations
Denmark
Nykoebing Falster County Hospital
Nykoebing Falster, Region Sjaelland, Denmark, 4800
Sponsors and Collaborators
Nykøbing Falster County Hospital
University of Southern Denmark
University Hospital Roskilde
Rigshospitalet, Denmark
Investigators
Principal Investigator: Lea L Andersen, MD Nykoebing Falster County Hospital
Study Director: Helga ME Gimbel, Dr.med.sci. University of Southern Denmark
  More Information

Publications:
Responsible Party: Lea Laird Andersen, MD, PhD.-student, Nykøbing Falster County Hospital
ClinicalTrials.gov Identifier: NCT01880710     History of Changes
Other Study ID Numbers: sj-268
Study First Received: May 14, 2013
Last Updated: June 14, 2013
Health Authority: Denmark: Ethics Committee

Keywords provided by Nykøbing Falster County Hospital:
long term follow-up
urinary incontinence
pelvic organ prolapse
total versus subtotal hysterectomy

Additional relevant MeSH terms:
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on July 24, 2014