Clinical trial NCT01880710: Total Versus Subtotal Abdominal Hysterectomy
Official title: Randomized Clinical Trial of Total Versus Subtotal Abdominal Hysterectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Benign Uterine Disease
Keywords: long term follow-up
urinary incontinence
pelvic organ prolapse
total versus subtotal hysterectomy
Lead sponsor: Nykøbing Falster County Hospital
Sponsor class: OTHER
Collaborators: name: University of Southern Denmark
name: Zealand University Hospital
name: Rigshospitalet, Denmark
First posted: 2013-06-19
Enrollment: 319
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: change in Urinary incontinence from baseline (preoperatively)
timeFrame: 2 months, 6months, 1, 5 and 15 years postoperatively
Secondary outcomes:
measure: pelvic organ prolapse
timeFrame: preoperatively, 2 months, 6months, 1, 5 and 15 years postoperatively
measure: cervical problems in the SAH group
timeFrame: preoperatively, 2 months, 6months, 1, 5 and 15 years postoperatively
measure: voiding difficulties and LUTS (Lower Urinary Tract Symptoms)
timeFrame: preoperatively, 2 months, 6 months, 1, 5 and 15 years postoperatively
Other outcomes:
measure: quality of life
timeFrame: preoperatively, 2 months, 6months, 1 and 15 years postoperatively
measure: sexuality
timeFrame: preoperatively, 2 months, 6months, 1, 5 and 15 years postoperatively
measure: pelvic pain
timeFrame: preoperatively, 2 months, 6months, 1, 5 and 15 years postoperatively
measure: bowel problems
timeFrame: preoperatively, 2 months, 6months, 1, 5 and 15 years postoperatively
measure: per- and postoperative complications
timeFrame: preoperatively, 2 months, 6months, 1, 5 and 15 years postoperatively
Locations:
city: Nykoebing Falster
country: Denmark
facility: Nykoebing Falster County Hospital
state: Region Sjaelland
Study officials:
affiliation: Nykoebing Falster County Hospital
name: Lea L Andersen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Southern Denmark
name: Helga ME Gimbel, Dr.med.sci.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Andersen LL, Moller LM, Gimbel HM. Low adherence to cervical cancer screening after subtotal hysterectomy. Dan Med J. 2015 Dec;62(12):A5165.
citation: 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.
citation: 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.
citation: 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.