Safety and Efficacy of Using the New Tissue Containment System During Laparoscopic Myomectomy Morcellation

Gynecologic Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04392674
• Other study ID #: NTCS-20200508
• Status: Recruiting
• Phase: N/A
• Start date: May 20, 2020
• Est. completion date: December 20, 2022

Study information

• Verified date: October 2022
• Source: China-Japan Friendship Hospital
• Contact: Fang Zhao, MD
• Phone: 861084206115
• Email: fangzhaow[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 20, 2022
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Gynecologic Surgery

Intervention

Device:
• the new tissue containment system
using the new tissue containment system during Laparoscopic myomectomy morcellation

Locations

Country	Name	City	State
China	China-Japan Friendship Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Jing Liang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The safety of using the new tissue containment system for contained cutting and extracting tissue during laparoscopic myomectomy morcellation	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.	approximately two years
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	Mean procedure time	Mean procedure time will be measured by hour/minutes.	approximately two years
Secondary	Estimated blood loss during operation	Blood loss during operation will be measured by volume (mL)	approximately two years
Secondary	Post-operative pain	Post-operative pain will be measured by Visual Analog Score - VAS	approximately two years
Secondary	Intra- or post-operative complications	Intra or post complications rate (e.g. urinary, intestinal or nerve injury)	approximately two years
Secondary	The Surgeon Task Load Index	The Surgeon Task Load Index be measured by designated Questionnaire.	approximately two years
Secondary	The Patients' life quality postoperative	The Patients' life quality postoperative be measured by Questionnaire.	approximately two years