Total Versus Subtotal Abdominal Hysterectomy

NCT01880710 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 319

Last updated 2014-09-25

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01880710 on ClinicalTrials.gov