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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01715597
First Posted: October 29, 2012
Last Update Posted: October 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Kidong Kim, Seoul National University Hospital
  Purpose
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.

Condition Intervention Phase
Uterine Leiomyoma Drug: ascorbic acid Drug: Normal saline Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Placebo-controlled,Doubled,Randomized Trial Evaluating the Effect of Intravenous Ascorbic Acid on Intraoperative Blood Loss in Women Undergoing Laparoscopic Myomectomy

Resource links provided by NLM:


Further study details as provided by Kidong Kim, Seoul National University Hospital:

Primary Outcome Measures:
  • blood loss [ Time Frame: during laparoscopic myomectomy ]

Other Outcome Measures:
  • time of operation [ Time Frame: during laparoscopic myomectomy ]
  • the amount of transfusion [ Time Frame: during laparoscopic myomectomy ]
  • 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)

  • acute urinary retention [ Time Frame: 2days after the operation ]

Enrollment: 50
Study Start Date: December 2012
Study Completion Date: October 2017
Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ascorbic acid
ascorbic acid 2g in normal saline 500ml IV start 2hours before the operation
Drug: ascorbic acid
ascorbic acid 2g in normal saline 500ml IV start 30min before the operation and infusion for 2 hour
Drug: Normal saline
normal saline 500ml IV
Placebo Comparator: Control
Normal saline 500ml IV infusion for 2hour
Drug: Normal saline
normal saline 500ml IV

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01715597


Locations
Korea, Republic of
Seoul National University Bundang Hospital
Gyeongg-ido, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: kiding kim, M.D. Seoul National University Bundang Hospital,Gyeongg-ido,Republic of Korea
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kidong Kim, Assistant professor in department of OBGY, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01715597     History of Changes
Other Study ID Numbers: SNUBH_GO_016
First Submitted: October 22, 2012
First Posted: October 29, 2012
Last Update Posted: October 31, 2017
Last Verified: October 2017

Keywords provided by Kidong Kim, Seoul National University Hospital:
uterine leiomyoma
laparoscopic myomectomy
intraoperative blood loss
ascorbic acid

Additional relevant MeSH terms:
Hemorrhage
Leiomyoma
Myofibroma
Pathologic Processes
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases
Ascorbic Acid
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Vitamins
Micronutrients
Growth Substances