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NCT Number: NCT01829022

Multi-center Prospective Study on E-NOTES 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.

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Key information

Age range

20 year and older

Sex eligibility

Female

Study type

Observational

Primary location

National Cancer Center, Goyang-si, Gyeonggi-do, South Korea

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About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

E-NOTES

Procedure

Embryonic-Natural Orifice Transumbilical Endoscopic Surgery for Myomectomy with Traction of Multidirectional Sutures

Other names: Embryonic-Natural Orifice Transumbilical Endoscopic Surgery

Primary outcomes

  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 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.

    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).

Sponsors and collaborators

Lead sponsor

National Cancer Center, Korea

Other Gov

Collaborators

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

Registry information

Official study title

Multi-center Prospective Study on Embryonic-Natural Orifice Transumbilical Endoscopic Surgery for Myomectomy With Traction of Multidirectional Sutures

Acronym: E-NOTES

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Apr 11, 2013
Registry last updated
Jun 26, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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