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

This study has been completed.
Sponsor:
Collaborators:
The Catholic University of Korea
The Catholic University of Korea ST.Vincent's hospital
Incheon St.Mary's Hospital
Kyung Hee University Gangdong Hospital
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
Hallym University Medical Center
Hanyang University
Information provided by (Responsible Party):
Myong Cheol Lim, National Cancer Center, Korea
ClinicalTrials.gov Identifier:
NCT01829022
First received: March 27, 2013
Last updated: June 24, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Myoma
Procedure: E-NOTES

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Multi-center Prospective Study on Embryonic-Natural Orifice Transumbilical Endoscopic Surgery for Myomectomy With Traction of Multidirectional Sutures

Resource links provided by NLM:


Further study details as provided by National Cancer Center, Korea:

Primary Outcome Measures:
  • Technical feasibilities and postoperative morbidity after E-NOTES for Myomectomy with Traction of Multidirectional Sutures [ Time Frame: Postoperative surveillance including pain evaluation as routine clinical practise for 1 months ] [ Designated as safety issue: Yes ]
    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 Outcome Measures:
  • 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. [ Time Frame: Preoperative and postoperative pain ] [ Designated as safety issue: No ]
    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).


Enrollment: 35
Study Start Date: April 2013
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
E-NOTES
Embryonic-Natural Orifice Transumbilical Endoscopic Surgery for Myomectomy with Traction of Multidirectional Sutures
Procedure: E-NOTES
Embryonic-Natural Orifice Transumbilical Endoscopic Surgery for Myomectomy with Traction of Multidirectional Sutures
Other Name: Embryonic-Natural Orifice Transumbilical Endoscopic Surgery

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

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with myoma which are surgically candidate at educational hospitals

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01829022

Locations
Korea, Republic of
National Cancer Center
Goyang, Gyeonggi, Korea, Republic of
National Cancer Center
Koyang-si, Korea, Republic of
Sponsors and Collaborators
National Cancer Center, Korea
The Catholic University of Korea
The Catholic University of Korea ST.Vincent's hospital
Incheon St.Mary's Hospital
Kyung Hee University Gangdong Hospital
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
Hallym University Medical Center
Hanyang University
Investigators
Principal Investigator: Myong Cheol Lim, MD, PhD National Cancer Center
  More Information

No publications provided

Responsible Party: Myong Cheol Lim, Senior researcher, National Cancer Center, Korea
ClinicalTrials.gov Identifier: NCT01829022     History of Changes
Other Study ID Numbers: NCCNCS-13-MAR
Study First Received: March 27, 2013
Last Updated: June 24, 2014
Health Authority: Korea: Institutional Review Board

Keywords provided by National Cancer Center, Korea:
Myoma
Uterine myomectomy

ClinicalTrials.gov processed this record on October 20, 2014