Status:
COMPLETED
Multi-center Prospective Study on E-NOTES for Myomectomy With Traction of Multidirectional Sutures
Lead Sponsor:
National Cancer Center, Korea
Collaborating Sponsors:
The Catholic University of Korea
Saint Vincent's Hospital, Korea
Conditions:
Myoma
Eligibility:
FEMALE
20+ years
Brief Summary
Primary objectives : To investigate technical feasibility and postoperative morbidity after E-NOTES for Myomectomy with Traction of Multidirectional Sutures Secondary objectives : To investigate post...
Detailed Description
* Leiomyoma is a common benign tumor of the smooth muscle cells of the myometrium.1 It can cause several symptoms such as abnormal vaginal bleeding, pain, or urinary symptoms according to size and loc...
Eligibility Criteria
Inclusion
- Women who are surgically candidate for myomectomy
- Age \> 20 years
Exclusion
- Contraindications for laparoscopic surgery and/or general anesthesia.
- Greater than five fibroids sized of 3cm or more
- Uterus extending beyond the umbilicus
- Major medical comorbidity or psychiatric illness, which could affect follow-up and/or compliance
- Patients undergoing concomitant complex surgical procedures at the time of myomectomy (such as resection of severe endometriosis etc.)
- Pregnancy
- Patients with any suggestion of malignancy in the pelvis
- Patients with cooperation of another main surgical procedures such as severe adhesiolysis or low anterior resection
- Patients who are severely anemic or who have significant medical conditions such as cardiac or pulmonary disease
- Patients who refuse to participate or give consent to the procedures
Key Trial Info
Start Date :
April 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT01829022
Start Date
April 1 2013
End Date
April 1 2014
Last Update
June 26 2014
Active Locations (2)
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1
National Cancer Center
Goyang-si, Gyeonggi-do, South Korea
2
National Cancer Center
Koyang-si, South Korea