Status:
UNKNOWN
Single Incision Laparoscopic Surgery (SILS) Versus Conventional Laparoscopic Hysterectomy
Lead Sponsor:
Samsung Medical Center
Conditions:
Uterine Myoma
Uterine Adenomyosis
Eligibility:
FEMALE
20-60 years
Phase:
PHASE3
Brief Summary
Multi-center prospective randomized trial of single port laparoscopic surgery (SILS) versus conventional 3-4 ports laparoscopic hysterectomy. Hypothesis is that conversion rate of SILS is not inferior...
Eligibility Criteria
Inclusion
- Symptomatic (dysmenorrhea, palpable mass, pelvic pain or discomfort urinary symptom, increasing size, menorrhagia) myomas or adenomyomas
- Uterine size \< gestational age of 14 weeks
- Informed consent
Exclusion
- Medical diseases such as heart failure, renal insufficiency, liver cirrhosis, pancreatitis, uncontrolled DM
- Huge uterine size \> gestational age of 14 weeks
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2013
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT01483417
Start Date
December 1 2011
End Date
March 1 2013
Last Update
February 22 2012
Active Locations (8)
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1
Keimyung University Dongsan Hospital
Deagu, South Korea
2
Catholic Incheon Hospital
Incheon, South Korea
3
Samsung Medical Center
Seoul, South Korea, 135-710
4
Asan Medical Center
Seoul, South Korea