CompletedNCT01829022E-NOTESUpdated Jun 26, 2014

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

An observational study in Myoma, sponsored by National Cancer Center, Korea. Completed at 2 sites in Korea, Republic of. Open to female participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2014-06-26.

Sponsored by National Cancer Center, Korea · Observational

Study type: Observational
Model: Case-only
Time perspective: Prospective
Enrollment: 35
Ages: 20 Years and older
Sex: Female

Study 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.

Read the 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.

Conditions studied

Myoma

Browse trials for

Myoma 61

Keywords

Myoma
Uterine myomectomy

In context

Myoma

61 studies on the registry are indexed under Myoma; 10 are open to participants now.

This study's enrollment of 35 is below the median of 111 across 13 observational studies indexed under Myoma.

Browse Myoma studies →

Lead sponsor

National Cancer Center, Korea is the lead sponsor of 204 studies on the registry; 36 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 20 Years and older
Sexes eligible: Female
Accepts healthy volunteers: No
Sampling method: Non-probability sample

Study population

Patients with myoma which are surgically candidate at educational hospitals

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Women who are surgically candidate for myomectomy
Age > 20 years

Exclusion criteria

Exclusion Criteria:

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 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

Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Study design

Observational model: Case-only
Time perspective: Prospective
Enrollment: 35 participants (actual)
Patient registry: No

Groups and cohorts

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

Interventions

ProcedureE-NOTES
Embryonic-Natural Orifice Transumbilical Endoscopic Surgery for Myomectomy with Traction of Multidirectional Sutures
Also known as: Embryonic-Natural Orifice Transumbilical Endoscopic Surgery

What researchers measure

Primary outcomes

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
Time frame: Postoperative surveillance including pain evaluation as routine clinical practise for 1 months

Secondary outcomes

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).
Time frame: Preoperative and postoperative pain

Study locations

2 sites

National Cancer Center
Goyang, Gyeonggi, Korea, Republic of
National Cancer Center
Koyang-si, Korea, Republic of

Timeline

Tracking since Sep 25, 2026

Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Apr 2013, a primary completion of Apr 2014 and a completion of Apr 2014. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered: Mar 27, 2013
First posted: Apr 11, 2013
Start: Apr 2013
Primary completionActual: Apr 2014
CompletionActual: Apr 2014
Last update: Jun 26, 2014

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Jun 26, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01829022
Lead 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
Responsible party: Myong Cheol Lim (Senior researcher, National Cancer Center, Korea) — Principal investigator
First posted: Apr 11, 2013
Start date: Apr 2013
Primary completion: Apr 2014
Completion: Apr 2014
Last update: Jun 26, 2014

Study contacts

Myong Cheol Lim, MD, PhD

principal investigator · National Cancer Center

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.

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