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Placebo-controlled,Doubled,Randomized Trial Evaluating the Effect of Intravenous Ascorbic Acid on Intraoperative Blood Loss in Women Undergoing Laparoscopic Myomectomy


Phase 3
N/A
N/A
Open (Enrolling)
Female
Uterine Leiomyoma

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Trial Information

Placebo-controlled,Doubled,Randomized Trial Evaluating the Effect of Intravenous Ascorbic Acid on Intraoperative Blood Loss in Women Undergoing Laparoscopic Myomectomy


Inclusion Criteria:



- uterine myoma

- be planning to laparoscopic myomectomy

- images ; the number of myoma <4

- images ; the diameter of the largest myoma <9cm

Exclusion Criteria:

- be planning other surgery in addition to laparoscopy

- clinically significant coagulation abnormality

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

blood loss

Outcome Time Frame:

during laparoscopic myomectomy

Safety Issue:

No

Principal Investigator

kiding kim, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Seoul National University Bundang Hospital,Gyeongg-ido,Republic of Korea

Authority:

Korea: Institutional Review Board

Study ID:

SNUBH_GO_016

NCT ID:

NCT01715597

Start Date:

December 2012

Completion Date:

January 2014

Related Keywords:

  • Uterine Leiomyoma
  • uterine leiomyoma
  • laparoscopic myomectomy
  • intraoperative blood loss
  • ascorbic acid
  • Hemorrhage
  • Leiomyoma
  • Myofibroma

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