Multi-center Prospective Study on E-NOTES for Myomectomy With Traction of Multidirectional Sutures
E-NOTES
1 other identifier
observational
35
1 country
2
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 postoperative pain after E-NOTES for Myomectomy with Traction of Multidirectional Sutures by clinical variables such as incision size, type of port, size and number of myoma, or operation time.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Apr 2013
Shorter than P25 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 27, 2013
CompletedStudy Start
First participant enrolled
April 1, 2013
CompletedFirst Posted
Study publicly available on registry
April 11, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2014
CompletedJune 26, 2014
June 1, 2014
1 year
March 27, 2013
June 24, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Technical feasibilities and postoperative morbidity after E-NOTES for Myomectomy with Traction of Multidirectional Sutures
Technical feasibility and postoperative morbidity will be evaluated in terms of overall or institutional conversion rate to convetional multi-port laparoscopy or laparotomy, operation time for each surgical procedures: dissection, morecellation, suturing, and total surgical procedures, complication, change of hemoglobin, and estimated blood loss
Postoperative surveillance including pain evaluation as routine clinical practise for 1 months
Secondary Outcomes (1)
Postoperative pain after E-NOTES for Myomectomy with Traction of Multidirectional Sutures by clinical variables such as incision size, type of port, size and number of myoma, or operation time.
Preoperative and postoperative pain
Study Arms (1)
E-NOTES
Embryonic-Natural Orifice Transumbilical Endoscopic Surgery for Myomectomy with Traction of Multidirectional Sutures
Interventions
Embryonic-Natural Orifice Transumbilical Endoscopic Surgery for Myomectomy with Traction of Multidirectional Sutures
Eligibility Criteria
Patients with myoma which are surgically candidate at educational hospitals
You may qualify if:
- Women who are surgically candidate for myomectomy
- Age \> 20 years
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Cancer Center, Korealead
- The Catholic University of Koreacollaborator
- Saint Vincent's Hospital, Koreacollaborator
- Incheon St.Mary's Hospitalcollaborator
- Kyung Hee University Hospital at Gangdongcollaborator
- Keimyung University Dongsan Medical Centercollaborator
- Korea University Guro Hospitalcollaborator
- Korea University Anam Hospitalcollaborator
- Cheil General Hospital and Women's Healthcare Centercollaborator
- National Health Insurance Service Ilsan Hospitalcollaborator
- Seoul National University Bundang Hospitalcollaborator
- Seoul National University Hospitalcollaborator
- Samsung Medical Centercollaborator
- Soonchunhyang University Hospitalcollaborator
- Ajou Universitycollaborator
- Pusan National University Yangsan Hospitalcollaborator
- Severance Hospitalcollaborator
- Asan Medical Centercollaborator
- Ewha Womans University Mokdong Hospitalcollaborator
- Inje Universitycollaborator
- CHA Universitycollaborator
- Kyungpook National University Hospitalcollaborator
- Hallym University Medical Centercollaborator
- Hanyang Universitycollaborator
Study Sites (2)
National Cancer Center
Goyang-si, Gyeonggi-do, South Korea
National Cancer Center
Koyang-si, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Myong Cheol Lim, MD, PhD
National Cancer Center
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior researcher
Study Record Dates
First Submitted
March 27, 2013
First Posted
April 11, 2013
Study Start
April 1, 2013
Primary Completion
April 1, 2014
Study Completion
April 1, 2014
Last Updated
June 26, 2014
Record last verified: 2014-06