MyomaE-NOTESNCT01829022
Multi-center Prospective Study on E-NOTES for Myomectomy With Traction of Multidirectional Sutures
An observational study of Myoma, run by National Cancer Center, Korea at 2 sites in South Korea.
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… Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Myoma
- What is being tested?
- E-NOTES
- Type of treatment
- Surgery or procedure
- How many people
- 35 participants
- Where
- 2 sitesSouth Korea
- Study dates
- Apr 2013to Apr 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with myoma which are surgically candidate at educational hospitals
Who may be able to join
- Women who are surgically candidate for myomectomy
- Age > 20 years
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
National Cancer Center
Goyang-si, Gyeonggi-do
National Cancer Center
Koyang-si
About this study
Official title: Multi-center Prospective Study on Embryonic-Natural Orifice Transumbilical Endoscopic Surgery for Myomectomy With Traction of Multidirectional Sutures
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
- Myoma
- Being tested
- E-NOTES
- Keywords
- Myoma, Uterine myomectomy
- Medical subject headings
- Myoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E-NOTESProcedure or surgery
Also called Embryonic-Natural Orifice Transumbilical Endoscopic Surgery
Embryonic-Natural Orifice Transumbilical Endoscopic Surgery for Myomectomy with Traction of Multidirectional Sutures
| Study group | Role | What they receive |
|---|---|---|
| E-NOTES | Embryonic-Natural Orifice Transumbilical Endoscopic Surgery for Myomectomy with Traction of Multidirectional Sutures Receives: Procedure: E-NOTES |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Postoperative surveillance including pain evaluation as routine clinical practise for 1 months
Secondary outcomes (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.
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).
Measured: Preoperative and postoperative pain
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- 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
- Principal investigator, Myong Cheol Lim, National Cancer Center, Korea
- Investigators
- Myong Cheol Lim, MD, PhD, Principal investigator, National Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01829022
- Sponsor's protocol ID
- NCCNCS-13-MAR
- Acronym
- E-NOTES
- Status last verified
- Jun 2014
- First submitted
- 27 Mar 2013
- Last updated
- 26 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center Prospective Study on Embryonic-Natural Orifice Transumbilical Endoscopic Surgery for Myomectomy With Traction of Multidirectional Sutures
- ClinicalTrials.gov ID
- NCT01829022
- Acronym / sponsor ID
- E-NOTES / NCCNCS-13-MAR
- Conditions
- Myoma
- Keywords
- Myoma, Uterine myomectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- National Cancer Center, KoreaOther government
- 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
- Study start
- Apr 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 11 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| E-NOTES | – | Procedure: E-NOTESEmbryonic-Natural Orifice Transumbilical Endoscopic Surgery for Myomectomy with Traction of Multidirectional Sutures |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with myoma which are surgically candidate at educational hospitals
Key inclusion criteria (2 listed)
- Women who are surgically candidate for myomectomy
- Age > 20 years
Key exclusion criteria (10 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| E-NOTESAlso: Embryonic-Natural Orifice Transumbilical Endoscopic SurgeryEmbryonic-Natural Orifice Transumbilical Endoscopic Surgery for Myomectomy with Traction of Multidirectional Sutures | Procedure or surgery | E-NOTES |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2014.
Related trials for Myoma
RecruitingObservational study
Association of Ultrasound Features of the Myometrium Suggestive of Adenomyosis and Clinical Symptoms
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Prescription of Letrozole for Uterine Myoma
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Prevention of Intra-uterine Adhesions Following Laparoscopic and Laparotomic Myomectomy
Myoma
Not yet recruitingObservational study
Prospective Perioperative Clinical Registry for Women Undergoing Benign Gynecological Surgery
Benign Gynecological Disease, Uterine Fibroids
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Terlipressin vs Placebo to Reduce Bleeding in Fibroid Surgery
Uterine Fibroids (Leiomyoma), Uterine Myoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Myong Cheol Lim, MD, PhD principal investigator
National Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myoma, run by National Cancer Center, Korea at 2 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2014.