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Total Versus Subtotal Abdominal Hysterectomy

Primary Purpose

Benign Uterine Disease

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Subtotal hysterectomy
Total Hysterectomy
Sponsored by
Nykøbing Falster County Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Benign Uterine Disease focused on measuring long term follow-up, urinary incontinence, pelvic organ prolapse, total versus subtotal hysterectomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Nykoebing Falster County Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Total hysterectomy

Subtotal Hysterectomy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

pelvic organ prolapse
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
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)
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.

Full Information

First Posted
May 14, 2013
Last Updated
September 24, 2014
Sponsor
Nykøbing Falster County Hospital
Collaborators
University of Southern Denmark, Zealand University Hospital, Rigshospitalet, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT01880710
Brief Title
Total Versus Subtotal Abdominal Hysterectomy
Official Title
Randomized Clinical Trial of Total Versus Subtotal Abdominal Hysterectomy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nykøbing Falster County Hospital
Collaborators
University of Southern Denmark, Zealand University Hospital, Rigshospitalet, Denmark

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Uterine Disease
Keywords
long term follow-up, urinary incontinence, pelvic organ prolapse, total versus subtotal hysterectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
319 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Total hysterectomy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Subtotal Hysterectomy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Subtotal hysterectomy
Intervention Description
Subtotal abdominal hysterectomy where the body of the uterus is removed but the cervix is spared.
Intervention Type
Procedure
Intervention Name(s)
Total Hysterectomy
Intervention Description
total abdominal hysterectomy where the body as well as the cervix of the uterus are removed.
Primary Outcome Measure Information:
Title
change in Urinary incontinence from baseline (preoperatively)
Description
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
Time Frame
2 months, 6months, 1, 5 and 15 years postoperatively
Secondary Outcome Measure Information:
Title
pelvic organ prolapse
Description
subjective measure by questionnaire at each time point as well as objective measure by POP-Q measurement at 15 years
Time Frame
preoperatively, 2 months, 6months, 1, 5 and 15 years postoperatively
Title
cervical problems in the SAH group
Description
questionnaire regarding bleeding at each time point, pap-smear regarding dysplasia at 15 years discharge summaries from hospital admissions/contacts regarding cervical problems.
Time Frame
preoperatively, 2 months, 6months, 1, 5 and 15 years postoperatively
Title
voiding difficulties and LUTS (Lower Urinary Tract Symptoms)
Description
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.
Time Frame
preoperatively, 2 months, 6 months, 1, 5 and 15 years postoperatively
Other Pre-specified Outcome Measures:
Title
quality of life
Description
SF-36 questionnaire at each time point
Time Frame
preoperatively, 2 months, 6months, 1 and 15 years postoperatively
Title
sexuality
Description
questionnaire at each time point
Time Frame
preoperatively, 2 months, 6months, 1, 5 and 15 years postoperatively
Title
pelvic pain
Description
questionnaire at each time point
Time Frame
preoperatively, 2 months, 6months, 1, 5 and 15 years postoperatively
Title
bowel problems
Description
questionnaire at each time point
Time Frame
preoperatively, 2 months, 6months, 1, 5 and 15 years postoperatively
Title
per- and postoperative complications
Description
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
Time Frame
preoperatively, 2 months, 6months, 1, 5 and 15 years postoperatively

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lea L Andersen, MD
Organizational Affiliation
Nykoebing Falster County Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Helga ME Gimbel, Dr.med.sci.
Organizational Affiliation
University of Southern Denmark
Official's Role
Study Director
Facility Information:
Facility Name
Nykoebing Falster County Hospital
City
Nykoebing Falster
State/Province
Region Sjaelland
ZIP/Postal Code
4800
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
12366489
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.
Results Reference
background
PubMed Identifier
16220584
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.
Results Reference
result
PubMed Identifier
14664880
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.
Results Reference
result
PubMed Identifier
14756739
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.
Results Reference
result
PubMed Identifier
26621394
Citation
Andersen LL, Moller LM, Gimbel HM. Low adherence to cervical cancer screening after subtotal hysterectomy. Dan Med J. 2015 Dec;62(12):A5165.
Results Reference
derived
PubMed Identifier
26231437
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.
Results Reference
derived
PubMed Identifier
26215904
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.
Results Reference
derived
PubMed Identifier
24917531
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.
Results Reference
derived

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Total Versus Subtotal Abdominal Hysterectomy

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