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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00876057 |
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Date of registration:
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03/04/2009 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Psychological Well-being, Recovery and Sexuality After Total and Subtotal Hysterectomy
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Scientific title:
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Subtotal Versus Total Abdominal Hysterectomy- a Prospective Randomised Comparison of Medical , Psychological and Sexual Effects. |
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Date of first enrolment:
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March 1998 |
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Target sample size:
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200 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00876057 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Sweden
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Contacts
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Name:
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Pär Persson, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital, Linköping |
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Name:
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Preben Kjölhede, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital, Linköping |
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Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Hysterectomy
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Intervention(s)
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Procedure: Total abdominal hysterectomy
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Procedure: Subtotal abdominal hysterectomy
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Primary Outcome(s)
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Psychological well-being
[Time Frame: One year after surgery]
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Secondary Outcome(s)
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Patient reported symptoms of pelvic organ dysfunction
[Time Frame: 7-14 years]
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Sexuality
[Time Frame: One year]
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Pelvic organ prolapse (anatomical)
[Time Frame: 7-14 years]
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Recovery of general well-being
[Time Frame: Five weeks after surgery]
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Secondary ID(s)
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2009-0102
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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