Safety, Efficacy and Operability of Using the New Tissue Containment System During Laprascopic Hysterectomy
NCT ID: NCT04423172
Last Updated: 2020-06-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
120 participants
INTERVENTIONAL
2020-06-16
2022-12-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Using the New Tissue Containment System group
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.
the new tissue containment system
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.
Open group
Without using any procteciton system during Laprascopic Hysterectomy.
No interventions assigned to this group
Interventions
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the new tissue containment system
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
FEMALE
No
Sponsors
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Jing Liang
OTHER
Responsible Party
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Jing Liang
professor
Central Contacts
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Other Identifiers
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NTCS-LH
Identifier Type: -
Identifier Source: org_study_id
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