Safety, Effectiveness and Operability of Using the New Tissue Containment System During Laparoscopic Ovarian Cystectomy

Surgery Clinical Trial

Official title:

Safety, Effectiveness and Operability of Using the New Tissue Containment System With Hard Pipes Which Can Assemble With Detachable Trocars Seamlessly for Tissue Removal During Laparoscopic Ovarian Cystectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04406597
• Other study ID #: NTCS-LOC
• Status: Recruiting
• Phase: N/A
• Start date: May 20, 2022
• Est. completion date: December 10, 2024

Study information

• Verified date: October 2022
• Source: China-Japan Friendship Hospital
• Contact: Yao Wang, MD
• Phone: 8684206115
• Email: wangyaopumc[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study is designed to evaluate the safety, effectiveness and operability of performing in-bag cystectomy and morcellation with the new tissue containment system during laparoscopic ovarian cystectomy. Premenopausal women, aged 18-45 undergoing laparoscopic cystectomy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 10, 2024
• Est. primary completion date: June 10, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Premenopausal woman patient age 18-45 years
• Women with regular period
• Women with ovarian neoplasm (size: 3-10cm)
• Laparoscopic surgery required
• Body mass index 18.5-27.9kg/m2
• Subject able to comprehend and give informed consent for participation in this study
• Signed informed consent form

Exclusion Criteria:

• Patient is not considered suitable for a laparoscopic ovarian cystectomy procedure
• The ovaries and pelvic cavity are severely adhered, and the tumor ruptures when free
• Women with Polycystic ovary syndrome
• Baseline AMH less than 0.5ng / mL
• Known to have participated in any other clinical trials or hormone therapy within 3 months
• Women during pregnancy and lactation
• Women in acute stage infection of reproductive system or other parts
• Women combined with severe central nervous system, cardiovascular system, liver and kidney, digestive tract, respiratory system, endocrine metabolism (thyroid disease, Cushing syndrome, hyperprolactinemia) and skeletal muscle system and mental disorders contraindicating laparoscopic surgery
• Women with known or suspected poor compliance who cannot complete the trial
• Those who can not sign the informed consent

Related Conditions & MeSH terms

• Ovarian Neoplasms
• Ovary Neoplasm
• Surgery

Intervention

Device:
• the New Tissue Containment System
Laparoscopic Ovarian Cystectomy using the New Tissue Containment System

Locations

Country	Name	City	State
China	China-Japan Friendship Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
China-Japan Friendship Hospital

Country where clinical trial is conducted

China, 

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".	End of study - approximately two years
Secondary	The ovarian reserve function	The ovarian reserve function is reflected by the concentration of anti-mullerian hormone(AMH)	Three months after the surgery
Secondary	Mean procedure time	Mean procedure time will be measured by hour/minutes.	Within one week after the surgery
Secondary	Estimated blood loss during operation	Blood loss during operation will be measured by volume (mL)	Within one week 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 patients' life quality postoperative: questionaire	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.	Three months after the surgery
Secondary	The Surgery 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 rate of failure during in-bag cystectomy procedure	Failure is defined as the operator's inability to successfully insert and extract the device.	End of study - approximately two years