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

Jing Liang0 sites120 target enrollmentJune 16, 2020

ConditionsGynecologic Surgery

Overview

Phase: N/A
Intervention: Not specified
Conditions: Gynecologic Surgery
Sponsor: Jing Liang
Enrollment: 120
Primary Endpoint: The exposure rate
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 16, 2020

End Date

December 26, 2022

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

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 18-65 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

Outcomes

Primary Outcomes

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".

Secondary Outcomes

Mean procedure time(Within one day after the surgery)
The probability of failure during in-bag morcellation procedure(approximately two years)
Estimated blood loss during operation(Within one day after the surgery)
Post-operative pain(Within one month after the surgery)
Rate of intra- or post-operative complications(Three months after the surgery)
The Surgeon Task Load Index(Within one week after the surgery)
The Patients' life quality postoperative(One months after the surgery)