Trial Information
Multi-institution, Randomized Trial for Efficacy and Safety of Single Incision Laparoscopic Surgery (SILS) Versus Conventional Laparoscopic Hysterectomy for the Treatment of Uterine Myoma or Adenomyosis
Inclusion Criteria:
- 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 Criteria:
- Medical diseases such as heart failure, renal insufficiency, liver cirrhosis,
pancreatitis, uncontrolled DM
- Huge uterine size > gestational age of 14 weeks
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Conversion rate
Outcome Description:
Conversion means that events required additional port(s) or open laparotomy
Outcome Time Frame:
1 week
Safety Issue:
Yes
Principal Investigator
Chi-Heum Cho, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Keimyung University Dongsan Medical Center
Authority:
Korea: Institutional Review Board
Study ID:
2011-10-004
NCT ID:
NCT01483417
Start Date:
December 2011
Completion Date:
March 2013
Related Keywords:
- Uterine Myoma
- Uterine Adenomyosis
- SILS
- Laparoscopic hysterectomy
- Cosmetic outcome
- Pain
- Myoma
- Leiomyoma
- Myofibroma
- Endometriosis