Safety, Efficacy and Operability of Using the New Tissue Containment System During Laprascopic Hysterectomy

Jing Liang120 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

120

Conditions

Gynecologic Surgery

Interventions

the new tissue containment systemDEVICE

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

The exposure rate

Exposure is defined as "disruption of the device (using dye leak testing or water testing) or visible tissue dissemination".

Time frame: approximately two years

Secondary Outcomes

Mean procedure time

Mean procedure time will be measured by hour/minutes.

Time frame: Within one day after the surgery

The probability of failure during in-bag morcellation procedure

Failure is defined as the operator's inability to successfully insert and extract the device.

Time frame: approximately two years

Estimated blood loss during operation

Blood loss during operation will be measured by volume (mL)

Time frame: Within one day after the surgery

Post-operative pain

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.

Time frame: Within one month after the surgery

Rate of intra- or post-operative complications

Intra or post complications rate (e.g. urinary, intestinal or nerve injury)

Time frame: Three months after the surgery

The Surgeon 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.

Time frame: Within one week after the surgery

Central Contacts

Jun Yang, MD

CONTACT

8684206115 kong-yj@163.com

Data from ClinicalTrials.gov

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