Total Versus Subtotal Abdominal Hysterectomy

NCT01880710 | Completed

• 1 other identifier: sj-268
• Study Type: interventional
• Target: 319
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

long term follow-up; urinary incontinence; pelvic organ prolapse; total versus subtotal hysterectomy

Outcome Measures

Primary Outcomes (1)

• change in Urinary incontinence from baseline (preoperatively)

  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

  2 months, 6months, 1, 5 and 15 years postoperatively

Secondary Outcomes (3)

• pelvic organ prolapse

  preoperatively, 2 months, 6months, 1, 5 and 15 years postoperatively

• cervical problems in the SAH group

  preoperatively, 2 months, 6months, 1, 5 and 15 years postoperatively

• voiding difficulties and LUTS (Lower Urinary Tract Symptoms)

  preoperatively, 2 months, 6 months, 1, 5 and 15 years postoperatively

Other Outcomes (5)

• quality of life

  preoperatively, 2 months, 6months, 1 and 15 years postoperatively

• sexuality

  preoperatively, 2 months, 6months, 1, 5 and 15 years postoperatively

• pelvic pain

  preoperatively, 2 months, 6months, 1, 5 and 15 years postoperatively

Study Arms (2)

Total hysterectomy

ACTIVE COMPARATOR

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

Subtotal Hysterectomy

EXPERIMENTAL

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

Interventions

Subtotal hysterectomy PROCEDURE

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

Subtotal Hysterectomy

Total Hysterectomy PROCEDURE

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

Total hysterectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nykøbing Falster County Hospital: lead
• University of Southern Denmark: collaborator
• Zealand University Hospital: collaborator
• Rigshospitalet, Denmark: collaborator

Study Sites (1)

Nykoebing Falster County Hospital

Nykoebing Falster, Region Sjælland, 4800, Denmark

Location

Related Publications (8)

• Gimbel H, Zobbe V, Ottesen BS, Tabor A. Randomized clinical trial of total vs. subtotal hysterectomy: validity of the trial questionnaire. Acta Obstet Gynecol Scand. 2002 Oct;81(10):968-74. doi: 10.1034/j.1600-0412.2002.811012.x.

  PMID: 12366489 BACKGROUND

• Gimbel H, Zobbe V, Andersen BJ, Sorensen HC, Toftager-Larsen K, Sidenius K, Moller N, Madsen EM, Vejtorp M, Clausen H, Rosgaard A, Villumsen J, Gluud C, Ottesen BS, Tabor A. Lower urinary tract symptoms after total and subtotal hysterectomy: results of a randomized controlled trial. Int Urogynecol J Pelvic Floor Dysfunct. 2005 Jul-Aug;16(4):257-62. doi: 10.1007/s00192-005-1291-8.

  PMID: 16220584 RESULT

• Gimbel H, Zobbe V, Andersen BM, Filtenborg T, Gluud C, Tabor A. Randomised controlled trial of total compared with subtotal hysterectomy with one-year follow up results. BJOG. 2003 Dec;110(12):1088-98.

  PMID: 14664880 RESULT

• Zobbe V, Gimbel H, Andersen BM, Filtenborg T, Jakobsen K, Sorensen HC, Toftager-Larsen K, Sidenius K, Moller N, Madsen EM, Vejtorp M, Clausen H, Rosgaard A, Gluud C, Ottesen BS, Tabor A. Sexuality after total vs. subtotal hysterectomy. Acta Obstet Gynecol Scand. 2004 Feb;83(2):191-6. doi: 10.1111/j.0001-6349.2004.00311.x.

  PMID: 14756739 RESULT

• Andersen LL, Moller LM, Gimbel HM. Low adherence to cervical cancer screening after subtotal hysterectomy. Dan Med J. 2015 Dec;62(12):A5165.

  PMID: 26621394 DERIVED

• Andersen LL, Alling Moller LM, Gimbel HM. Objective comparison of subtotal vs. total abdominal hysterectomy regarding pelvic organ prolapse and urinary incontinence: a randomized controlled trial with 14-year follow-up. Eur J Obstet Gynecol Reprod Biol. 2015 Oct;193:40-5. doi: 10.1016/j.ejogrb.2015.06.033. Epub 2015 Jul 9.

  PMID: 26231437 DERIVED

• Andersen LL, Moller LM, Gimbel H; Danish Hysterectomy Trial Group. Lower urinary tract symptoms after subtotal versus total abdominal hysterectomy: exploratory analyses from a randomized clinical trial with a 14-year follow-up. Int Urogynecol J. 2015 Dec;26(12):1767-72. doi: 10.1007/s00192-015-2778-6. Epub 2015 Jul 28.

  PMID: 26215904 DERIVED

• Andersen LL, Zobbe V, Ottesen B, Gluud C, Tabor A, Gimbel H; Danish Hysterectomy Trial Group. Five-year follow up of a randomised controlled trial comparing subtotal with total abdominal hysterectomy. BJOG. 2015 May;122(6):851-857. doi: 10.1111/1471-0528.12914. Epub 2014 Jun 11.

  PMID: 24917531 DERIVED

MeSH Terms

Conditions

Urinary Incontinence; Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Prolapse; Pathological Conditions, Anatomical

Study Officials

• Lea L Andersen, MD

  Nykoebing Falster County Hospital

  PRINCIPAL INVESTIGATOR

• Helga ME Gimbel, Dr.med.sci.

  University of Southern Denmark

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD.-student

Study Record Dates

• First Submitted: May 14, 2013
• First Posted: June 19, 2013
• Study Start: August 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: February 1, 2014
• Last Updated: September 25, 2014

Record last verified: 2014-09

Locations

DK (1)