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A Randomized Controlled Trial of Hand-assisted Laparoscopic Myomectomy Versus Abdominal Myomectomy: Surgical Outcomes and Patient Satisfactions


Phase 3
18 Years
70 Years
Open (Enrolling)
Female
Uterine Myomas

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Trial Information

A Randomized Controlled Trial of Hand-assisted Laparoscopic Myomectomy Versus Abdominal Myomectomy: Surgical Outcomes and Patient Satisfactions


Inclusion Criteria:



Inclusion criteria were as follows: women who had myoma-related symptoms such as
menorrhagia, pelvic pressure/pain, or infertility; women who were not pregnant at the time
of presentation (i.e., negative for urine pregnancy test or last menstrual period within
the last 4 weeks); and women who were appropriated medical status for laparoscopic surgery
(American Society of Anesthesiologists Physical Status classification 1 or 2).

Exclusion Criteria:

Exclusion criteria included any other uterine or adnexal abnormalities (e.g., abnormal
endometrial thickness, and suspected ovarian or uterine malignancy), any sign of genital
infection, presence of submucosal or pedunculated myoma as a dominant myoma, treatment of
gonadotropin-releasing hormone (GnRH) agonist 2 months before surgery, or an inability to
understand and provide written informed consent.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Patient satisfaction about surgery

Outcome Time Frame:

1 month after surgery

Safety Issue:

No

Authority:

Republic of Korea: Institutional Review Board

Study ID:

KNC13-012

NCT ID:

NCT01858454

Start Date:

March 2013

Completion Date:

Related Keywords:

  • Uterine Myomas
  • Myoma
  • Leiomyoma
  • Myofibroma

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