Study of Different Pain Scores in Single-Port Access (SPA) Laparoscopic Hysterectomy Versus Conventional Laparoscopic Hysterectomy
NCT ID: NCT01064128
Last Updated: 2011-07-20
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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COMPLETED
PHASE3
40 participants
INTERVENTIONAL
2010-01-31
2010-12-31
Brief Summary
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The attempt to further reduce the operative trauma in laparoscopic hysterectomy led in new technique such as Single-Port Access (SPA) laparoscopic surgery. This new technique is considered as painless procedure and better cosmetic effect but there are not any publications to study a possible different pain score and cosmetic effect in new techniques versus conventional laparoscopic hysterectomy. In this randomized controlled study the researchers have investigated the pain scores and cosmetic satisfaction by modified body image scale and cosmetic scar scale.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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conventional laparoscopic hysterectomy
Three or four ports conventional laparoscopic hysterectomy
conventional laparoscopic hysterectomy
conventional 3 or 4 ports laparoscopic hysterectomy
SPA laparoscopic hysterectomy
Single umbilical incision laparoscopic hysterectomy
SPA laparoscopic hysterectomy
single-port access laparoscopic hysterectomy
Interventions
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conventional laparoscopic hysterectomy
conventional 3 or 4 ports laparoscopic hysterectomy
SPA laparoscopic hysterectomy
single-port access laparoscopic hysterectomy
Eligibility Criteria
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Inclusion Criteria
* Symptomatic (Dysmenorrhea, Palpable mass, Pelvic pain or discomfort, Urinary symptom, Increasing size, Menorrhagia) myomas or adenomyosis
* Suspected uterine myoma and/or adenomyosis on transvaginal ultrasonography (USG)
* At least a 6-month thorough follow-up record available
* Informed consent
Exclusion Criteria
* Body Mass Index more than 30
* Huge uterus defined by longitudinal uterine diameter larger than 10cm and anteroposterior diameter larger than 8cm in USG
30 Years
60 Years
FEMALE
No
Sponsors
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Samsung Medical Center
OTHER
Responsible Party
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Samsung Medical Center
Locations
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Samsung Medical Center
Seoul, , South Korea
Countries
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Other Identifiers
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2009-09-093
Identifier Type: -
Identifier Source: org_study_id
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