Safety and Efficacy of Using PK Morcellator With Pneumoliner Containment Hysterectomy

Safety and Efficacy of Using PK Morcellator With Pneumoliner Bag for Laparoscopic Morcellation With Laparoscopic Instrument for Tissue Containment and Removal During Laparoscopic Supracervical Hysterectomy or Total Laparoscopic Hysterectomy

The study is designed to evaluate the safety of performing in-bag morcellation of uterus tissues during laparoscopic hysterectomy (LSH or TLH). Pre- and perimenopausal women, aged 35-50 undergoing laparoscopic supracervical hysterectomy (LSH) or total laparoscopic hysterectomy (TLH)

Inclusion Criteria:

• Pre- and Peri-menopausal woman patient age 35-50 years
• Women with fibroids and indication for laparoscopic hysterectomy at which a morcellators for cutting and extraction of tissue is required.
• Normal Pap test result in the last year
• Hemoglobin level of 10.0 g/dL or more at the time of treatment
• 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 hysterectomy procedure
• Women with:
• Known or suspected gynecologic malignancy
• Known cervical dysplasia
• Postmenopausal women
• Undiagnosed vaginal bleeding
• Abdominal wall thickness is larger than 10 cm
• Atypical hyperplasia or malignancy in preoperative endometrial biopsy.
• Known cognitive disorder
• HIV or any other immunosuppressive disorder
• Liver disease
• Renal failure (Serum creatinine above 2.5 dL/ml)
• Cardiopulmonary disease contraindicating laparoscopic surgery
• History or evidence of gynecologic malignancy within the past five years
• Pace maker, internal defibrillator/cardio converter
• Impaired coagulation parameters
• Previous extensive pelvic surgery
• Psychological/psychiatric disease
• Contraindications to anesthesia or abdominal surgery.
• Concurrent participation in any other clinical study