Status:
TERMINATED
Hand-assisted Laparoscopic Surgery (HALS) for Myomectomy
Lead Sponsor:
CHA University
Conditions:
Uterine Myomas
Eligibility:
FEMALE
18-70 years
Phase:
PHASE3
Brief Summary
The aim of this study was to evaluate the feasibility and usefulness of Hand-assisted laparoscopic surgery (HALS) for myomectomy, and compare it with the open approach in myomectomy.
Detailed Description
Uterine myomas are the most common benign tumor of the female genital tract and the leading indication for hysterectomy. Despite the fact that laparoscopic myomectomy is becoming increasingly popular,...
Eligibility Criteria
Inclusion
- Inclusion criteria were as follows: 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); and women who were appropriated medical status for laparoscopic surgery (American Society of Anesthesiologists Physical Status classification 1 or 2).
Exclusion
- Exclusion criteria included any other uterine or adnexal abnormalities (e.g., abnormal endometrial thickness, and suspected ovarian or uterine malignancy), any sign of genital infection, presence of submucosal or pedunculated myoma as a dominant myoma, treatment of gonadotropin-releasing hormone (GnRH) agonist 2 months before surgery, or an inability to understand and provide written informed consent.
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT01858454
Start Date
March 1 2013
End Date
April 1 2015
Last Update
April 16 2015
Active Locations (1)
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1
CHA Gangnam Medical Center
Seoul, South Korea