Safety and Efficacy of Using the New Tissue Containment System With Hard Pipes Which Can Assemble With Detachable Trocars Seamlessly for Tissue Removal During Laparoscopic Myomectomy Morcellation

Jing Liang1 site in 1 country400 target enrollmentMay 20, 2020

ConditionsGynecologic Surgery

Overview

Phase: N/A
Intervention: Not specified
Conditions: Gynecologic Surgery
Sponsor: Jing Liang
Enrollment: 400
Locations: 1
Primary Endpoint: The safety of using the new tissue containment system for contained cutting and extracting tissue during laparoscopic myomectomy morcellation
Status: Recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The study is designed to evaluate the safety of performing the new tissue containment system during laparoscopic myomectomy morcellation. Pre- and perimenopausal women, aged 18-45 undergoing laparoscopic myomectomy morcellation

Registry

clinicaltrials.gov

Start Date

May 20, 2020

End Date

December 20, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Jing Liang

Responsible Party

Sponsor Investigator

Principal Investigator

Jing Liang

professor

China-Japan Friendship Hospital

Eligibility Criteria

Inclusion Criteria

•Pre- and Peri-menopausal woman patient age 18-45 years
•Women with fibroids and indication for laparoscopic myomectomy.
•Normal Pap smear result within one year
•MRI ( Magnatic Resonance Imaging ) or other imaging findings indicate the diameter of the largest uterine fibroids is between 4 to 10cm.
•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 with severe pelvic adhesion found during the operation
•The body mass index of the patient ≥ 28kg/m2
•Diameter of a single uterine fibroid\>10cm
•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

Outcomes

Primary Outcomes

The safety of using the new tissue containment system for contained cutting and extracting tissue during laparoscopic myomectomy morcellation

Time Frame: approximately two years

The safety of using the new tissue containment system for cutting and extracting tissue during laparoscopic myomectomy morcellation will be determined by the rate of leakage Leakage is defined as "disruption of the device (using dye leak testing) or visible tissue dissemination.

Secondary Outcomes

The probability of failure during in-bag morcellation procedure(approximately two years)
The Patients' life quality postoperative(approximately two years)
Mean procedure time(approximately two years)
The Surgeon Task Load Index(approximately two years)
Post-operative pain(approximately two years)
Intra- or post-operative complications(approximately two years)
Estimated blood loss during operation(approximately two years)