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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-03-31

Study Completion Date

2005-04-30

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.

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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.

Conditions

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Hysterectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TH

Total hysterectomy

Group Type ACTIVE_COMPARATOR

Total abdominal hysterectomy

Intervention Type PROCEDURE

Total abdominal hysterectomy

SH

Subtotal hysterectomy

Group Type ACTIVE_COMPARATOR

Subtotal abdominal hysterectomy

Intervention Type PROCEDURE

Subtotal abdominal hysterectomy

Interventions

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Total abdominal hysterectomy

Intervention Type PROCEDURE

Subtotal abdominal hysterectomy

Intervention Type PROCEDURE

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No