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

Not Applicable

• Conditions: Gynecologic Surgery
• Interventions: Device: the new tissue containment system

• Registration Number: NCT04423172
• Lead Sponsor: Jing Liang

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-05
• Study First Submitted: 2020-05-25
• Study First Submitted QC: 2020-06-08
• Last Update Submitted: 2020-06-08
• Study First Posted: 2020-06-09
• Last Update Posted: 2020-06-09
• Study Start: 2020-06-16
• Primary Completion: 2021-06-16
• Study Completion: 2022-12-26

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Using the New Tissue Containment System group	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.

Primary Outcome Measures

Name	Time	Method
The exposure rate	approximately two years	Exposure is defined as "disruption of the device (using dye leak testing or water testing) or visible tissue dissemination".

Secondary Outcome Measures

Name	Time	Method
Mean procedure time	Within one day after the surgery	Mean procedure time will be measured by hour/minutes.
The probability of failure during in-bag morcellation procedure	approximately two years	Failure is defined as the operator's inability to successfully insert and extract the device.
Estimated blood loss during operation	Within one day after the surgery	Blood loss during operation will be measured by volume (mL)
Post-operative pain	Within one month after the surgery	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.
Rate of intra- or post-operative complications	Three months after the surgery	Intra or post complications rate (e.g. urinary, intestinal or nerve injury)
The Surgeon Task Load Index	Within one week after the surgery	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.
The Patients' life quality postoperative	One months after the surgery	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.