Multi-center Prospective Study on E-NOTES for Myomectomy With Traction of Multidirectional Sutures

Myoma Clinical Trial

— E-NOTES  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01829022
• Other study ID #: NCCNCS-13-MAR
• Status: Completed
• Phase: N/A
• First received: March 27, 2013
• Last updated: June 24, 2014
• Start date: April 2013
• Est. completion date: April 2014

Study information

• Verified date: June 2014
• Source: National Cancer Center, Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Myoma

Intervention

Procedure:
• E-NOTES
Embryonic-Natural Orifice Transumbilical Endoscopic Surgery for Myomectomy with Traction of Multidirectional Sutures

Locations

Country	Name	City	State
Korea, Republic of	National Cancer Center	Goyang	Gyeonggi
Korea, Republic of	National Cancer Center	Koyang-si

Sponsors (24)

Lead Sponsor

Collaborator

National Cancer Center, Korea

Ajou University, Asan Medical Center, CHA University, Cheil General Hospital and Women’s Healthcare Center, Ewha Womans University Mokdong Hospital, Hallym University Medical Center, Hanyang University, Incheon St.Mary's Hospital, Inje University, Keimyung University Dongsan Medical Center, Korea University Anam Hospital, Korea University Guro Hospital, Kyung Hee University Hospital at Gangdong, Kyungpook National University, National Health Insurance Service Ilsan Hospital, Pusan National University Yangsan Hospital, Saint Vincent's Hospital, Korea, Samsung Medical Center, Seoul National University Bundang Hospital, Seoul National University Hospital, Severance Hospital, Soonchunhyang University Hospital, The Catholic University of Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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.	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).	Preoperative and postoperative pain	No