Myoma Clinical Trial
Official title:
Multi-center Prospective Study on Embryonic-Natural Orifice Transumbilical Endoscopic Surgery for Myomectomy With Traction of Multidirectional Sutures
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.
- 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.
;
Observational Model: Case-Only, Time Perspective: Prospective
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