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

Gynecologic Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04423172
• Other study ID #: NTCS-LH
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 16, 2020
• Est. completion date: December 26, 2022

Study information

• Verified date: May 2020
• Source: China-Japan Friendship Hospital
• Contact: Jun Yang, MD
• Phone: 8684206115
• Email: kong-yj[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: December 26, 2022
• Est. primary completion date: June 16, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Gynecologic Surgery

Intervention

Device:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Jing Liang

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The exposure rate	Exposure is defined as "disruption of the device (using dye leak testing or water testing) or visible tissue dissemination".	approximately two years
Secondary	Mean procedure time	Mean procedure time will be measured by hour/minutes.	Within one day after the surgery
Secondary	The probability of failure during in-bag morcellation procedure	Failure is defined as the operator's inability to successfully insert and extract the device.	approximately two years
Secondary	Estimated blood loss during operation	Blood loss during operation will be measured by volume (mL)	Within one day after the surgery
Secondary	Post-operative pain	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
Secondary	Rate of intra- or post-operative complications	Intra or post complications rate (e.g. urinary, intestinal or nerve injury)	Three months after the surgery
Secondary	The Surgeon Task Load Index	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
Secondary	The Patients' life quality postoperative	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