Study on the Effect of Intravenous Ascorbic Acid on Intraoperative Blood Loss in Women With Uterine Myoma

Seoul National University

Status and phase: Completed; Phase 3

Conditions: Uterine Leiomyoma

Treatments: Drug: ascorbic acid; Drug: Normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT01715597

SNUBH_GO_016

Details and patient eligibility

About

The investigators want to know whether the intravenous ascorbic acid would reduce the blood loss during laparoscopic myoma surgery. The investigators randomized patients into intravenous ascorbic acid group and placebo group and examined the blood loss in both groups.

Enrollment: 50 patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups, including a placebo group

ascorbic acid

Experimental group

Description:

ascorbic acid 2g in normal saline 500ml IV start 2hours before the operation

Treatment:

Drug: ascorbic acid

Drug: Normal saline

Control

Placebo Comparator group

Description:

Normal saline 500ml IV infusion for 2hour

Treatment:

Drug: Normal saline