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
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
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 |
Country | Name | City | State |
---|---|---|---|
China | China-Japan Friendship Hospital | Beijing |
Lead Sponsor | Collaborator |
---|---|
Jing Liang |
China,
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 |
Status | Clinical Trial | Phase | |
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Active, not recruiting |
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