Long Term Outcomes Following Total Laparoscopic Hysterectomy and Laparoscopic Supracervical Hysterectomy
NCT ID: NCT01289314
Last Updated: 2011-02-10
Study Results
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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UNKNOWN
NA
62 participants
INTERVENTIONAL
2011-02-28
2012-12-31
Brief Summary
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Design: Prospective randomised trial.
Null hypothesis 1: There is no significant difference in occurrence and intensity of pelvic pain following TLH compared with following LSH.
Null hypothesis 2: There is no significant difference in patient satisfaction and quality of life following TLH compared with following LSH.
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Detailed Description
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Methods: The study participants are randomised to total laparoscopic hysterectomy (n = 31), or laparoscopic supracervical hysterectomy (n = 31).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Total laparoscopic hysterectomy
TLH
Total laparoscopic hysterectomy (TLH)
Laparoscopic supracervical hysterectomy
Laparoscopic supracervical hysterectomy
Laparoscopic supracervical hysterectomy (LSH)
Interventions
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TLH
Total laparoscopic hysterectomy (TLH)
Laparoscopic supracervical hysterectomy
Laparoscopic supracervical hysterectomy (LSH)
Eligibility Criteria
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Inclusion Criteria
* benign condition requiring hysterectomy
* Dysmenorrohea/cyclic pelvic pain
* Informed consent
Exclusion Criteria
* Women with a previous history of cervical dysplasia, with cellular changes suggestive of dysplasia in preoperative cervical smear.
* Women with atypical hyperplasia or malignancy in preoperative endometrial biopsy.
* Women with a substantially enlarged uterus requiring abdominal hysterectomy or not suitable for TLH (\> 12 week amenorrhea).
* Women with a concomitant condition requiring uni- or bilateral oophorectomy.
* Postmenopausal women.
* Women with no dysmenorrohea/cyclic pelvic pain (\<1 on a 10-point visual analogue scale).
* Women with deep infiltrating endometriosis.
FEMALE
No
Sponsors
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Oslo University Hospital
OTHER
Responsible Party
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Dept. of Gynecology, Oslo University Hospital
Principal Investigators
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Marit Lieng, MD PHD
Role: STUDY_DIRECTOR
Dept. of Gynecology, Oslo University Hospital, Norway
Locations
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Dept. of Gynecology, Oslo University Hospital
Oslo, Oslo County, Norway
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Homepage of Oslo University Hospital
Other Identifiers
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LAP-HYST-TRIAL
Identifier Type: -
Identifier Source: org_study_id
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