The study is designed to evaluate the safety of performing the new tissue containment system during laparoscopic myomectomy morcellation. Pre- and perimenopausal women, aged 18-45 undergoing laparoscopic myomectomy morcellation
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
400
using the new tissue containment system during Laparoscopic myomectomy morcellation
China-Japan Friendship Hospital
Beijing, China
RECRUITINGThe safety of using the new tissue containment system for contained cutting and extracting tissue during laparoscopic myomectomy morcellation
The safety of using the new tissue containment system for cutting and extracting tissue during laparoscopic myomectomy morcellation will be determined by the rate of leakage Leakage is defined as "disruption of the device (using dye leak testing) or visible tissue dissemination.
Time frame: approximately two years
The probability of failure during in-bag morcellation procedure
Failure is defined as the operator's inability to successfully insert and extract the device.
Time frame: approximately two years
Mean procedure time
Mean procedure time will be measured by hour/minutes.
Time frame: approximately two years
Estimated blood loss during operation
Blood loss during operation will be measured by volume (mL)
Time frame: approximately two years
Post-operative pain
Post-operative pain will be measured by Visual Analog Score - VAS
Time frame: approximately two years
Intra- or post-operative complications
Intra or post complications rate (e.g. urinary, intestinal or nerve injury)
Time frame: approximately two years
The Surgeon Task Load Index
The Surgeon Task Load Index be measured by designated Questionnaire.
Time frame: approximately two years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The Patients' life quality postoperative
The Patients' life quality postoperative be measured by Questionnaire.
Time frame: approximately two years