Clinical trial NCT01829022: Multi-center Prospective Study on E-NOTES for Myomectomy With Traction of Multidirectional Sutures
Official title: Multi-center Prospective Study on Embryonic-Natural Orifice Transumbilical Endoscopic Surgery for Myomectomy With Traction of Multidirectional Sutures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myoma
Keywords: Myoma
Uterine myomectomy
Lead sponsor: National Cancer Center, Korea
Sponsor class: OTHER_GOV
Collaborators: name: The Catholic University of Korea
name: Saint Vincent's Hospital, Korea
name: Incheon St.Mary's Hospital
name: Kyung Hee University Hospital at Gangdong
name: Keimyung University Dongsan Medical Center
name: Korea University Guro Hospital
name: Korea University Anam Hospital
name: Cheil General Hospital and Women's Healthcare Center
name: National Health Insurance Service Ilsan Hospital
name: Seoul National University Bundang Hospital
name: Seoul National University Hospital
name: Samsung Medical Center
name: Soonchunhyang University Hospital
name: Ajou University
name: Pusan National University Yangsan Hospital
name: Severance Hospital
name: Asan Medical Center
name: Ewha Womans University Mokdong Hospital
name: Inje University
name: CHA University
name: Kyungpook National University Hospital
name: Hallym University Medical Center
name: Hanyang University
First posted: 2013-04-11
Enrollment: 35
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with myoma which are surgically candidate at educational hospitals

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.

Eligibility criteria: 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

Primary outcomes:
measure: Technical feasibilities and postoperative morbidity after E-NOTES for Myomectomy with Traction of Multidirectional Sutures
timeFrame: Postoperative surveillance including pain evaluation as routine clinical practise for 1 months
Secondary outcomes:
measure: 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.
timeFrame: Preoperative and postoperative pain
Other outcomes:
Locations:
city: Goyang
country: Korea, Republic of
facility: National Cancer Center
state: Gyeonggi
city: Koyang-si
country: Korea, Republic of
facility: National Cancer Center
Study officials:
affiliation: National Cancer Center
name: Myong Cheol Lim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: