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OpenTrials
Completed

NCT Number: NCT01715597

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

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.

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Key information

Conditions

Uterine Leiomyoma Connective Tissue Diseases Myofibroma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Skin and Connective Tissue Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Seoul National University Bundang Hospital

Gyeongg-ido, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ascorbic acid

Drug

ascorbic acid 2g in normal saline 500ml IV start 30min before the operation and infusion for 2 hour

normal saline

Drug

normal saline 500ml IV

Primary outcomes

  1. blood loss

    Time frame: during laparoscopic myomectomy

Other outcomes

  1. time of operation

    Time frame: during laparoscopic myomectomy

  2. the amount of transfusion

    Time frame: during laparoscopic myomectomy

  3. the difference of hemoglobin

    Time frame: postoperative day 1

    postoperative day 1 hemoglobin - preoperative hemoglobin + hemoglobin increased by transfusion (hemoglobin 1 per RBC 1 pack transfusion)

  4. acute urinary retention

    Time frame: 2days after the operation

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Oct 29, 2012
Registry last updated
Oct 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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