Gynecologic Surgery
Conditions
Keywords
morcellation, laparoscopic surgery, hysterectomy
Brief summary
The study is designed to evaluate the safety, operability and efficacy of performing the new tissue containment system during laparoscopic hysterectomy. Pre- and perimenopausal women undergoing laparoscopic hysterectomy.
Interventions
Using the new tissue containment system during Laparoscopic hysterectomy. The divice is a soft specimen bag in which the uterus tissue is sealed and quickly morcellation and removed through vagina. The divice is named the new tissue containment system.
Sponsors
Jing Liang
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Pre- and Peri-menopausal woman patient age 18-65 years * Women with fibroids, adenomyosis, and endometrial hyperplasia and indication for laparoscopic hysterectomy. * Normal Pap smear result within one year * The uterus is larger than 12 weeks of gestation * 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 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 exposure rate | approximately two years | Exposure is defined as disruption of the device (using dye leak testing or water testing) or visible tissue dissemination. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Estimated blood loss during operation | Within one day after the surgery | Blood loss during operation will be measured by volume (mL) |
| Post-operative pain | Within one month after the surgery | The patients' post-operative pain will be measured by The Visual Analog Score （VAS).The maximum value is 10 and the minimum is 0. The lower score means a better outcome. |
| Mean procedure time | Within one day after the surgery | Mean procedure time will be measured by hour/minutes. |
| The Surgeon Task Load Index | 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. |
| The Patients' life quality postoperative | One 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. |
| Rate of intra- or post-operative complications | Three months after the surgery | Intra or post complications rate (e.g. urinary, intestinal or nerve injury) |
Contacts
Primary ContactJun Yang, MD
Outcome results
None listed