Psychological Well-being, Recovery and Sexuality After Total and Subtotal Hysterectomy

Study Overview
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Brief Summary
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The purpose of this study is to determine whether psychological well-being, recovery and sexuality differs in women undergoing subtotal and total abdominal hysterectomy. Se also Detailed Description for additional study.

Detailed Description
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An additional study study based on the material in original study started in april 2011. The purpose of this study is to investigate the development of pelvis organ prolapse in the long term (median eleven years after hysterectomy and by questionnaires, Pelvic-floor Distress Inventory SF-20 analyze if patient reported symptoms regarding urinary-and bowels functions differs regarding the method of hysterectomy.

Official Title
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Subtotal Versus Total Abdominal Hysterectomy- a Prospective Randomised Comparison of Medical , Psychological and Sexual Effects.

Conditions
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Hysterectomy

Intervention / Treatment
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* Procedure: Total abdominal hysterectomy
* Procedure: Subtotal abdominal hysterectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primarily uterine fibroids with bleeding disturbance or mechanical symptoms but other benign disorders were hysterectomy was recommended were also eligible After surgery at least one ovary preserved. Informed verbal and written consent Proficiency in Swedish Exclusion Criteria: Malignancy in the genital organs. Previous or present cervical dysplasia. Rapidly growing fibroids where malignancy could not be ruled out Preoperative treatment with GnRH analogues. Postmenopausal women without hormone therapy Severe psychiatric disorder

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TH<br>Total hysterectomy | Procedure: Total abdominal hysterectomy<br>* Total abdominal hysterectomy<br>|
| Active Comparator: SH<br>Subtotal hysterectomy | Procedure: Subtotal abdominal hysterectomy<br>* Subtotal abdominal hysterectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychological well-being |  | One year after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recovery of general well-being |  | Five weeks after surgery | 
| Sexuality |  | One year | 
| Pelvic organ prolapse (anatomical) | Follow-up median eleven years after the initial hysterectomy. Clinical investigation including POP-Q. | 7-14 years | 
| Patient reported symptoms of pelvic organ dysfunction | Follow-up median eleven years after the initial hysterectomy. Questionnaire (Pelvic Floor Dysfuntion Inventoy). | 7-14 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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psychological well-being, recovery, time in hospital, sick-leave, complications, Sexual well-being