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

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.

Study Overview

• Status: Completed
• Conditions: Myoma
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 35

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Patients with myoma which are surgically candidate at educational hospitals

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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 Names: Embryonic-Natural Orifice Transumbilical Endoscopic Surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Postoperative surveillance including pain evaluation as routine clinical practise for 1 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Preoperative and postoperative pain

Collaborators and Investigators

• Sponsor: National Cancer Center, Korea
• Collaborators: Samsung Medical Center; Asan Medical Center; Seoul National University Hospital; Korea University Anam Hospital; Seoul National University Bundang Hospital; Korea University Guro Hospital; Cheil General Hospital and Women's Healthcare Center; Kyungpook National University Hospital; Inje University; Hanyang University; The Catholic University of Korea; Severance Hospital; CHA University; Ewha Womans University Mokdong Hospital; Keimyung University Dongsan Medical Center; Kyung Hee University Hospital at Gangdong; Soonchunhyang University Hospital; Pusan National University Yangsan Hospital; Hallym University Medical Center; Saint Vincent's Hospital, Korea; Incheon St.Mary's Hospital; National Health Insurance Service Ilsan Hospital; Ajou University
• Investigators: Principal Investigator: Myong Cheol Lim, MD, PhD, National Cancer Center

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (ACTUAL): April 1, 2014
• Study Completion (ACTUAL): April 1, 2014

Study Registration Dates

• First Submitted: March 27, 2013
• First Submitted That Met QC Criteria: April 8, 2013
• First Posted (ESTIMATE): April 11, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): June 26, 2014
• Last Update Submitted That Met QC Criteria: June 24, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Keywords: Myoma; Uterine myomectomy
• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Muscle Tissue; Myoma
• Other Study ID Numbers: NCCNCS-13-MAR