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Vasopressin Versus Epinephrine in Myomectomy

Information source: CHA University
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Uterine Myomas

Intervention: Epinephrine (Drug); Vasopressin (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: CHA University

Overall contact:
Taejong Song, M.D., Phone: +82-10-4035-8405, Email: taejong.song@gmail.com

Summary

Uterine myomas (fibroids or leiomyomas) are the most common benign tumor of the female genital tract and the leading indication for hysterectomy. Although hysterectomy is the definitive treatment of myomas, myomectomy remains the gold standard treatment for women desiring future fertility and uterine conservation3. However, bleeding is often a problem in myomectomy and can results in intraoperative hypovolemic shock, postoperative anemia, pelvic infection, and adhesions with infertility. A number of interventions have been introduced to reduce hemorrhage during myomectomy. Two categories of interventions can be identified: (a) Vascular interventions on uterine and/or ovarian arteries such as artery clamping, tying, or embolization; (b) pharmacologic interventions such as vasopressin, epinephrine, oxytocin, ergometrine, misoprostol, sulprostone, and gonadotropin-releasing hormone (GnRH) agonist4-11. Of these, intraoperative local injection of vasopressin causing vasospasm is most commonly used. However, there is not a wide consensus on the use of this agent because of serious side effects reported in literature. In addition, in several countries, including France and Italy, vasopressin has not been commercialized because of its potential adverse effects on cardiovascular system. Epinephrine also induces a vasoconstrictive effect on tissue that lasts longer than that of vasopressin (5-6 hours versus 7-35 minutes) and is used during various gynecological surgeries, endoscopic resection, and dermatologic procedures to reduce blood loss. However, there are a few studies for the use of epinephrine to reduce hemorrhage during myomectomy. Furthermore, a randomized comparison of epinephrine and vasopressin as hemostatic agents during myomectomy has never been conducted. To test the hypothesis that the injections of epinephrine and vasopressin during myomectomy are equivalent in reducing blood loss, the investigators performed this randomized controlled study.

Clinical Details

Official title: Use of Vasopressin Versus Epinephrine to Reduce Hemorrhage During Myomectomy: a Randomized Controlled Trial

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

Primary outcome: Operative blood loss

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

- women who had myoma-related symptoms such as menorrhagia, pelvic pressure/pain, or

infertility

- women who were not pregnant at the time of presentation (i. e., negative for urine

pregnancy test or last menstrual period within the last 4 weeks)

- women who were appropriated medical status for laparoscopic surgery (American Society

of Anesthesiologists Physical Status classification 1 or 2). Exclusion Criteria:

- any pelvic abnormalities requiring concomitant surgery

- the presence of pedunculated subserosal or submucosal myoma as a dominant myoma

- the presence of myoma of maximum diameter 10 cm based on the preoperative ultrasound

- more than 4 myomas

- treatment of GnRH agonist or unipristal acetate within 3 months before surgery

- an inability to understand and provide written informed consent.

Locations and Contacts

Taejong Song, M.D., Phone: +82-10-4035-8405, Email: taejong.song@gmail.com

CHA Gangnam Medical Center, Seoul 135-081, Korea, Republic of; Recruiting
Taejong Song, M.D., Phone: +81-10-4035-8405, Email: taejong.song@gmail.com
Additional Information

Starting date: May 2013
Last updated: June 24, 2014

Page last updated: August 20, 2015

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