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Multi-center Prospective Study on Embryonic-Natural Orifice Transumbilical Endoscopic Surgery for Myomectomy With Traction of Multidirectional Sutures

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Trial Information

Multi-center Prospective Study on Embryonic-Natural Orifice Transumbilical Endoscopic Surgery for Myomectomy With Traction of Multidirectional Sutures

- 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 location. Steadily, lesser invasive surgeries have been preferred
for such benign disease (laparotomy, laparoscopy, and then single-port surgery).2,3

- However, these minimal approaches, laparoscopic morcellation of preoperatively
suspicious leimyoma, have the potential risk of peritoneal seeding of postoperative
diagnosed leiomyosarcoma in the pathological examination.4 Currently, safe morcellation
is also required during myomectomy while using a lesser invasive surgical approach such
as single-port surgery or natural orifice transumbilical endoscopic surgery (NOTES).

- During single-port surgery or embryonic NOTES (E-NOTES) via an umbilicus, handling of
myoma into different directions could be quite a big challenge. Fortunately, myoma is
enough hard to pull with string and has a tendency not to rupture during manipulation
of these strings.

- These concepts lead to traction of anchoring sutures during E-NOTES for myomectomy
applied in the current case. Safe morcellation could be guaranteed, because direction
morcellation via an umbilicus is possible in an endobag.

- This useful and safe surgical approach needs to be confirmed in multi-centers in terms
of feasibility and morbidity.

Inclusion Criteria:

- Women who are surgically candidate for myomectomy

- Age > 20 years

Exclusion Criteria:

- 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

- 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

Type of Study:


Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Technical feasibilities and postoperative morbidity after E-NOTES for Myomectomy with Traction of Multidirectional Sutures

Outcome Description:

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

Outcome Time Frame:

Postoperative surveillance including pain evaluation as routine clinical practise for 1 months

Safety Issue:


Principal Investigator

Myong Cheol Lim, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Center


Korea: Institutional Review Board

Study ID:




Start Date:

April 2013

Completion Date:

April 2014

Related Keywords:

  • Myoma
  • Myoma
  • Uterine myomectomy
  • Myoma