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

This study is currently recruiting participants.
Verified April 2013 by Seoul National University Hospital
Sponsor:
Information provided by (Responsible Party):
Kidong Kim, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01715597
First received: October 22, 2012
Last updated: April 30, 2013
Last verified: April 2013
History of Changes
  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
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • blood loss [ Time Frame: during laparoscopic myomectomy ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • time of operation [ Time Frame: during laparoscopic myomectomy ] [ Designated as safety issue: No ]
  • the amount of transfusion [ Time Frame: during laparoscopic myomectomy ] [ Designated as safety issue: No ]
  • the difference of hemoglobin [ Time Frame: postoperative day 1 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: December 2012
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (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
Placebo Comparator: Control
Normal saline 500ml IV infusion for 2hour

  Eligibility

Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01715597

Contacts
Contact: Kidong kim, M.D. 82-31-787-7262 kidong.kim.md@gmail.com

Locations
Korea, Republic of
Seoul National University Bundang Hospital Recruiting
Gyeongg-ido, Korea, Republic of
Contact: kidong kim, M.D         kiding.kim.md@gmail.com    
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

No publications provided

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
Study First Received: October 22, 2012
Last Updated: April 30, 2013
Health Authority: Korea: Institutional Review Board
Korea: Food and Drug Administration

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

Additional relevant MeSH terms:
Leiomyoma
Myofibroma
Hemorrhage
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
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on May 22, 2013