Safety and Efficacy of Using the New Tissue Containment System During Laparoscopic Myomectomy Morcellation

Study Overview
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Brief Summary
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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

Official Title
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Safety and Efficacy of Using the New Tissue Containment System With Hard Pipes Which Can Assemble With Detachable Trocars Seamlessly for Tissue Removal During Laparoscopic Myomectomy Morcellation

Conditions
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Gynecologic Surgery

Intervention / Treatment
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* Device: the new tissue containment system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pre- and Peri-menopausal woman patient age 18-45 years Women with fibroids and indication for laparoscopic myomectomy. Normal Pap smear result within one year MRI ( Magnatic Resonance Imaging ) or other imaging findings indicate the diameter of the largest uterine fibroids is between 4 to 10cm. The body mass index of the patients is 18.5-27.9kg/m2 Signed informed consent form Exclusion Criteria: • Women with Known or suspected malignancy patients with severe pelvic adhesion found during the operation The body mass index of the patient ≥ 28kg/m2 Diameter of a single uterine fibroid>10cm patients during pregnancy and lactation Known blood diseases, bleeding coagulation disease, any part of the active bleeding or bleeding tendency of the constitution of the patient Patients with known severe liver and kidney dysfunction;Liver function (ALT, AST) ≥ 2 times of normal upper limit, or renal function (Cr) ≥ normal upper limit Patients who are known to have participated in any other clinical trial within 3 months Patients who cannot sign informed consent Patients with acute stage infection of the reproductive system or other sites

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: using the new tissue containment system<br>using the new tissue containment system during Laparoscopic myomectomy morcellation | Device: the new tissue containment system<br>* using the new tissue containment system during Laparoscopic myomectomy morcellation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The 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. | approximately two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The probability of failure during in-bag morcellation procedure | Failure is defined as the operator's inability to successfully insert and extract the device. | approximately two years | 
| Mean procedure time | Mean procedure time will be measured by hour/minutes. | approximately two years | 
| Estimated blood loss during operation | Blood loss during operation will be measured by volume (mL) | approximately two years | 
| Post-operative pain | Post-operative pain will be measured by Visual Analog Score - VAS | approximately two years | 
| Intra- or post-operative complications | Intra or post complications rate (e.g. urinary, intestinal or nerve injury) | approximately two years | 
| The Surgeon Task Load Index | The Surgeon Task Load Index be measured by designated Questionnaire. | approximately two years | 
| The Patients' life quality postoperative | The Patients' life quality postoperative be measured by Questionnaire. | approximately two years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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morcellation, myomectomy, laparoscopic surgery