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NCT Number: NCT01880710

Total Versus Subtotal Abdominal Hysterectomy

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.

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Key information

Conditions

Benign Uterine Disease Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pelvic Organ Prolapse Prolapse Signs and Symptoms Urinary Incontinence Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Nykoebing Falster County Hospital

Nykoebing Falster, Region Sjælland, 4800, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Subtotal hysterectomy

Procedure

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

Total Hysterectomy

Procedure

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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.

  3. 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.

Other outcomes

  1. quality of life

    Time frame: preoperatively, 2 months, 6months, 1 and 15 years postoperatively

    SF-36 questionnaire at each time point

  2. sexuality

    Time frame: preoperatively, 2 months, 6months, 1, 5 and 15 years postoperatively

    questionnaire at each time point

  3. pelvic pain

    Time frame: preoperatively, 2 months, 6months, 1, 5 and 15 years postoperatively

    questionnaire at each time point

  4. bowel problems

    Time frame: preoperatively, 2 months, 6months, 1, 5 and 15 years postoperatively

    questionnaire at each time point

  5. 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

Sponsors and collaborators

Lead sponsor

Nykøbing Falster County Hospital

Other

Collaborators

  • Rigshospitalet, Denmark
  • University of Southern Denmark
  • Zealand University Hospital

Registry information

Official study title

Randomized Clinical Trial of Total Versus Subtotal Abdominal Hysterectomy

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Jun 19, 2013
Registry last updated
Sep 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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