Gynecologic Surgery
Conditions
Keywords
morcellation, myomectomy, laparoscopic surgery
Brief 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
Interventions
using the new tissue containment system during Laparoscopic myomectomy morcellation
Sponsors
Jing Liang
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The safety of using the new tissue containment system for contained cutting and extracting tissue during laparoscopic myomectomy morcellation | approximately two years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean procedure time | approximately two years | Mean procedure time will be measured by hour/minutes. |
| Estimated blood loss during operation | approximately two years | Blood loss during operation will be measured by volume (mL) |
| Post-operative pain | approximately two years | Post-operative pain will be measured by Visual Analog Score - VAS |
| The probability of failure during in-bag morcellation procedure | approximately two years | Failure is defined as the operator's inability to successfully insert and extract the device. |
| The Surgeon Task Load Index | approximately two years | The Surgeon Task Load Index be measured by designated Questionnaire. |
| The Patients' life quality postoperative | approximately two years | The Patients' life quality postoperative be measured by Questionnaire. |
| Intra- or post-operative complications | approximately two years | Intra or post complications rate (e.g. urinary, intestinal or nerve injury) |
Countries
China
Contacts
Primary ContactFang Zhao, MD
Backup ContactYao Wang, PHD
Outcome results
None listed