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

June 8, 2020 updated by: Jing Liang

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

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.

Study Overview

Status

Unknown

Conditions

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
No Intervention: Open group
Without using any procteciton system during Laprascopic Hysterectomy.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 16, 2020

Primary Completion (Anticipated)

June 16, 2021

Study Completion (Anticipated)

December 26, 2022

Study Registration Dates

First Submitted

May 25, 2020

First Submitted That Met QC Criteria

June 8, 2020

First Posted (Actual)

June 9, 2020

Study Record Updates

Last Update Posted (Actual)

June 9, 2020

Last Update Submitted That Met QC Criteria

June 8, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • NTCS-LH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

IPD will to be shared with other researchers after four years

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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