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

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ClinicalTrials.gov Identifier: NCT01829022
Recruitment Status : Completed
First Posted : April 11, 2013
Last Update Posted : June 26, 2014
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment
Myoma Procedure: E-NOTES

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.

Study Design

Study Type : Observational
Actual Enrollment : 35 participants
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
Study Start Date : April 2013
Primary Completion Date : April 2014
Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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 ]
    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 :
  1. 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 ]
    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).


Eligibility Criteria

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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
Hallym University Medical Center
Hanyang University
Investigators
Principal Investigator: Myong Cheol Lim, MD, PhD National Cancer Center
More Information

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
First Posted: April 11, 2013    Key Record Dates
Last Update Posted: June 26, 2014
Last Verified: June 2014

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