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Vasopressin Versus Epinephrine for Laparoscopic Myomectomy: a Randomized Controlled Trial


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

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Trial Information

Vasopressin Versus Epinephrine for Laparoscopic Myomectomy: a Randomized Controlled Trial


Inclusion Criteria:



- 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)

- women who were appropriated medical status for laparoscopic surgery (American Society
of Anesthesiologists Physical Status classification 1 or 2).

Exclusion Criteria:

- 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

- presence of intramural or subserous myomas of maximum diameter 10 cm based on the
ultrasound, presence of more than 10 myomas

- 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), Primary Purpose: Treatment

Outcome Measure:

Estimated blood loss

Outcome Time Frame:

1 day after surgery

Safety Issue:

No

Authority:

Republic of Korea: Institutional Review Board

Study ID:

KNC13-013

NCT ID:

NCT01861015

Start Date:

April 2013

Completion Date:

April 2016

Related Keywords:

  • Uterine Myomas
  • Myoma
  • Leiomyoma
  • Myofibroma

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