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

Jing Liang

Status: Unknown

Conditions: Gynecologic Surgery

Treatments: Device: the new tissue containment system

Study type: Interventional

Funder types: Other

Identifiers

NCT04423172

NTCS-LH

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 2 patient groups

Using the New Tissue Containment System group

Experimental group

Description:

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.

Treatment:

Device: the new tissue containment system

Open group

No Intervention group

Description:

Without using any procteciton system during Laprascopic Hysterectomy.