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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04406597
Recruitment Status : Not yet recruiting
First Posted : May 28, 2020
Last Update Posted : May 28, 2020
Sponsor:
Information provided by (Responsible Party):
Jing Liang, China-Japan Friendship Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Ovary Neoplasm Surgery Device: the New Tissue Containment System Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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
Estimated Study Start Date : June 10, 2020
Estimated Primary Completion Date : June 10, 2021
Estimated Study Completion Date : December 10, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: the New Tissue Containment System group
Using the New Tissue Containment System during Laparoscopic Ovarian Cystectomy
Device: the New Tissue Containment System
Laparoscopic Ovarian Cystectomy using the New Tissue Containment System

No Intervention: Open group
Without any protection system during Laparoscopic Ovarian Cystectomy



Primary Outcome Measures :
  1. The exposure rate [ Time Frame: End of study - approximately two years ]
    • Exposure is defined as "disruption of the device (using dye leak testing or water testing) or visible tissue dissemination".


Secondary Outcome Measures :
  1. The ovarian reserve function [ Time Frame: Three months after the surgery ]
    The ovarian reserve function is reflected by the concentration of anti-mullerian hormone(AMH)

  2. Mean procedure time [ Time Frame: Within one week after the surgery ]
    Mean procedure time will be measured by hour/minutes.

  3. Estimated blood loss during operation [ Time Frame: Within one week after the surgery ]
    Blood loss during operation will be measured by volume (mL)

  4. Rate of Intra- or post-operative complications [ Time Frame: Three months after the surgery ]
    Intra or post complications rate (e.g. urinary, intestinal or nerve injury)

  5. The patients' life quality postoperative: questionaire [ Time Frame: Three months after the surgery ]
    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.

  6. The Surgery Task Load Index [ Time Frame: Within one week after the surgery ]
    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.

  7. The rate of failure during in-bag cystectomy procedure [ Time Frame: End of study - approximately two years ]
    Failure is defined as the operator's inability to successfully insert and extract the device.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04406597


Contacts
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Contact: Yao Wang, MD 8684206115 wangyaopumc@163.com

Sponsors and Collaborators
China-Japan Friendship Hospital
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Responsible Party: Jing Liang, Vice Director of Obstetrics and Gynecology, China-Japan Friendship Hospital
ClinicalTrials.gov Identifier: NCT04406597    
Other Study ID Numbers: NTCS-LOC
First Posted: May 28, 2020    Key Record Dates
Last Update Posted: May 28, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders