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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00876057
Recruitment Status : Completed
First Posted : April 6, 2009
Last Update Posted : June 11, 2012
Information provided by (Responsible Party):
Preben Kjolhede, University Hospital, Linkoeping

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Hysterectomy Procedure: Total abdominal hysterectomy Procedure: Subtotal abdominal hysterectomy Phase 4

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Subtotal Versus Total Abdominal Hysterectomy- a Prospective Randomised Comparison of Medical , Psychological and Sexual Effects.
Study Start Date : March 1998
Actual Primary Completion Date : April 2004
Actual Study Completion Date : April 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hysterectomy
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: TH
Total hysterectomy
Procedure: Total abdominal hysterectomy
Total abdominal hysterectomy
Active Comparator: SH
Subtotal hysterectomy
Procedure: Subtotal abdominal hysterectomy
Subtotal abdominal hysterectomy

Primary Outcome Measures :
  1. Psychological well-being [ Time Frame: One year after surgery ]

Secondary Outcome Measures :
  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).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00876057

Höglandssjukhuset i Eksjö
Eksjö, Sweden, 57581
Ryhov Central Hospital
Jönköping, Sweden, 55185
County Hospital in Kalmar
Kalmar, Sweden, 39185
Motala Counbty Hospital
Motala, Sweden, 59185
Vrinnevi Hospital
Norrköping, Sweden, 601 82
Värnamo County Hospital
Värnamo, Sweden, 33185
Capio Läkargruppen
Örebro, Sweden, 70146
Sponsors and Collaborators
University Hospital, Linkoeping
Study Chair: Preben Kjölhede, MD, PhD University Hospital, Linköping
Study Director: Pär Persson, MD University Hospital, Linköping

Responsible Party: Preben Kjolhede, Professor, University Hospital, Linkoeping Identifier: NCT00876057     History of Changes
Other Study ID Numbers: 2009-0102
First Posted: April 6, 2009    Key Record Dates
Last Update Posted: June 11, 2012
Last Verified: June 2012

Keywords provided by Preben Kjolhede, University Hospital, Linkoeping:
psychological well-being
time in hospital
Sexual well-being