Safety, Efficacy and Operability of Using the New Tissue Containment System During Laprascopic Hysterectomy

Study Overview
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Brief Summary
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The study is designed to evaluate the safety, operability and efficacy of performing the new tissue containment system during laparoscopic hysterectomy. Pre- and perimenopausal women undergoing laparoscopic hysterectomy.

Official Title
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Safety, Efficacy and Operability of Using the New Tissue Containment System With Hard Pipes Which Can Assemble With Detachable Trocars Seamlessly for Tissue Removal During Laprascopic Hysterectomy

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 18-65 years Women with fibroids, adenomyosis, and endometrial hyperplasia and indication for laparoscopic hysterectomy. Normal Pap smear result within one year The uterus is larger than 12 weeks of gestation 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 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: 65 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Using the New Tissue Containment System group<br>using the new tissue containment system during Laparoscopic Hysterectomy. The divice is a soft specimen bag in which the uterus tissue is sealed and quickly morcellation and removed through vagina. The divice is named the new tissue containment system. | Device: the new tissue containment system<br>* Using the new tissue containment system during Laparoscopic hysterectomy. The divice is a soft specimen bag in which the uterus tissue is sealed and quickly morcellation and removed through vagina. The divice is named the new tissue containment system.<br>|
| No Intervention: Open group<br>Without using any procteciton system during Laprascopic Hysterectomy. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The exposure rate | Exposure is defined as disruption of the device (using dye leak testing or water testing) or visible tissue dissemination. | approximately two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean procedure time | Mean procedure time will be measured by hour/minutes. | Within one day after the surgery | 
| 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 | 
| Estimated blood loss during operation | Blood loss during operation will be measured by volume (mL) | Within one day after the surgery | 
| Post-operative pain | The patients' post-operative pain will be measured by The Visual Analog Score （VAS).The maximum value is 10 and the minimum is 0. The lower score means a better outcome. | Within one month after the surgery | 
| Rate of intra- or post-operative complications | Intra or post complications rate (e.g. urinary, intestinal or nerve injury) | Three months after the surgery | 
| The Surgeon Task Load Index | The Surgery Task Load Index will be measured by questionaire. The maximum value is 120 and the minimum is 0. The higher score means a worse outcome. | Within one week after the surgery | 
| The Patients' life quality postoperative | The patients' life quality will be measured by The World Health Organization's Quality of Life Questionnaire-Brief Version（WHOQOL-BREF).The maximum value is 120 and the minimum is 0. The higher score means a better outcome. | One months after the surgery | 

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