Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01829022
Recruitment Status : Completed
First Posted : April 11, 2013
Last Update Posted : June 26, 2014
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
Myong Cheol Lim, National Cancer Center, Korea

Tracking Information
First Submitted Date March 27, 2013
First Posted Date April 11, 2013
Last Update Posted Date June 26, 2014
Study Start Date April 2013
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 8, 2013)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: April 8, 2013)
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).
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with myoma which are surgically candidate at educational hospitals
Condition Myoma
Intervention Procedure: E-NOTES
Embryonic-Natural Orifice Transumbilical Endoscopic Surgery for Myomectomy with Traction of Multidirectional Sutures
Other Name: Embryonic-Natural Orifice Transumbilical Endoscopic Surgery
Study Groups/Cohorts E-NOTES
Embryonic-Natural Orifice Transumbilical Endoscopic Surgery for Myomectomy with Traction of Multidirectional Sutures
Intervention: Procedure: E-NOTES
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 24, 2014)
35
Original Estimated Enrollment
 (submitted: April 8, 2013)
50
Actual Study Completion Date April 2014
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: Female
Ages 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT01829022
Other Study ID Numbers NCCNCS-13-MAR
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Myong Cheol Lim, National Cancer Center, Korea
Study Sponsor National Cancer Center, Korea
Collaborators
  • 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
Investigators
Principal Investigator: Myong Cheol Lim, MD, PhD National Cancer Center
PRS Account National Cancer Center, Korea
Verification Date June 2014