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Completed

NCT Number: NCT00876057

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

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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Key information

Conditions

Hysterectomy Behavior Personal Satisfaction Psychological Well-Being

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Höglandssjukhuset i Eksjö, Eksjö, Sweden

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Total abdominal hysterectomy

Procedure

Total abdominal hysterectomy

Subtotal abdominal hysterectomy

Procedure

Subtotal abdominal hysterectomy

Primary outcomes

  1. Psychological well-being

    Time frame: One year after surgery

Secondary outcomes

  1. Recovery of general well-being

    Time frame: Five weeks after surgery

  2. Sexuality

    Time frame: One year

  3. Pelvic organ prolapse (anatomical)

    Time frame: 7-14 years

    Follow-up median eleven years after the initial hysterectomy. Clinical investigation including POP-Q.

  4. Patient reported symptoms of pelvic organ dysfunction

    Time frame: 7-14 years

    Follow-up median eleven years after the initial hysterectomy. Questionnaire (Pelvic Floor Dysfuntion Inventoy).

Sponsors and collaborators

Lead sponsor

University Hospital, Linkoeping

Other

Registry information

Official study title

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

Important dates

Study start
1998
Primary completion
2004
Study completion
2005
First posted
Apr 6, 2009
Registry last updated
Jun 11, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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