Total Versus Subtotal Abdominal Hysterectomy

Benign Uterine Disease Clinical Trial

Official title:

Randomized Clinical Trial of Total Versus Subtotal Abdominal Hysterectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01880710
• Other study ID #: sj-268
• Status: Completed
• Phase: N/A
• First received: May 14, 2013
• Last updated: September 24, 2014
• Start date: August 2012
• Est. completion date: February 2014

Study information

• Verified date: September 2014
• Source: Nykøbing Falster County Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 319
• Est. completion date: February 2014
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Benign Uterine Disease
• Uterine Diseases

Intervention

Procedure:
• Subtotal hysterectomy
Subtotal abdominal hysterectomy where the body of the uterus is removed but the cervix is spared.
• Total Hysterectomy
total abdominal hysterectomy where the body as well as the cervix of the uterus are removed.

Locations

Country	Name	City	State
Denmark	Nykoebing Falster County Hospital	Nykoebing Falster	Region Sjaelland

Sponsors (4)

Lead Sponsor	Collaborator
Nykøbing Falster County Hospital	Rigshospitalet, Denmark, University Hospital Roskilde, University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

References & Publications (4)

Gimbel H, Zobbe V, Andersen BJ, Sørensen HC, Toftager-Larsen K, Sidenius K, Møller 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 — View 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. — View 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. — View Citation

Zobbe V, Gimbel H, Andersen BM, Filtenborg T, Jakobsen K, Sørensen HC, Toftager-Larsen K, Sidenius K, Møller N, Madsen EM, Vejtorp M, Clausen H, Rosgaard A, Gluud C, Ottesen BS, Tabor A. Sexuality after total vs. subtotal hysterectomy. Acta Obstet Gynecol — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	quality of life	SF-36 questionnaire at each time point	preoperatively, 2 months, 6months, 1 and 15 years postoperatively	No
Other	sexuality	questionnaire at each time point	preoperatively, 2 months, 6months, 1, 5 and 15 years postoperatively	No
Other	pelvic pain	questionnaire at each time point	preoperatively, 2 months, 6months, 1, 5 and 15 years postoperatively	No
Other	bowel problems	questionnaire at each time point	preoperatively, 2 months, 6months, 1, 5 and 15 years postoperatively	No
Other	per- and postoperative complications	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	preoperatively, 2 months, 6months, 1, 5 and 15 years postoperatively	No
Primary	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	No
Secondary	pelvic organ prolapse	subjective measure by questionnaire at each time point as well as objective measure by POP-Q measurement at 15 years	preoperatively, 2 months, 6months, 1, 5 and 15 years postoperatively	No
Secondary	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.	preoperatively, 2 months, 6months, 1, 5 and 15 years postoperatively	No
Secondary	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.	preoperatively, 2 months, 6 months, 1, 5 and 15 years postoperatively	No