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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


Phase 3
20 Years
60 Years
Open (Enrolling)
Female
Uterine Myoma, Uterine Adenomyosis

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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

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