Myoma
Conditions
Keywords
Myoma, Uterine myomectomy
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.
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 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.
Interventions
PROCEDUREE-NOTES
Embryonic-Natural Orifice Transumbilical Endoscopic Surgery for Myomectomy with Traction of Multidirectional Sutures
Sponsors
The Catholic University of Korea
Saint Vincent's Hospital, Korea
Incheon St.Mary's Hospital
Kyung Hee University Hospital at Gangdong
Keimyung University Dongsan Medical Center
Korea University Guro Hospital
Korea University Anam Hospital
Cheil General Hospital and Women's Healthcare Center
National Health Insurance Service Ilsan Hospital
Seoul National University Bundang Hospital
Seoul National University Hospital
Samsung Medical Center
Soonchunhyang University Hospital
Ajou University
Pusan National University Yangsan Hospital
Severance Hospital
Asan Medical Center
Ewha Womans University Mokdong Hospital
Inje University
CHA University
Kyungpook National University Hospital
Hallym University Medical Center
Hanyang University
National Cancer Center, Korea
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to No maximum
Healthy volunteers
No
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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Technical feasibilities and postoperative morbidity after E-NOTES for Myomectomy with Traction of Multidirectional Sutures | Postoperative surveillance including pain evaluation as routine clinical practise for 1 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Visual analogue scale will be used for pain evaluation: preoperative, postoperative 24 hour, postoperative 48 hour, postoperative 10 day (7 to 10 day), and postoperative 28 day (21 to 35 day). |
Countries
South Korea
Outcome results
None listed