Safety and Efficacy of Using PK Morcellator With Pneumoliner Containment Hysterectomy

Study Overview
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Brief Summary
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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)

Official Title
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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

Conditions
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Gynecologic Surgery

Intervention / Treatment
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* Device: Olympus PK Morcellator in PneumoLiner


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Olympus PK Morcellator in PneumoLiner<br>Laparoscopic Supracervical Hysterectomy (LSH) or Total Laparoscopic Hysterectomy (TLH) using the Olympus PK Morcellator in PneumoLiner containment device | Device: Olympus PK Morcellator in PneumoLiner<br>* Laparoscopic Supracervical Hysterectomy (LSH) or Total Laparoscopic Hysterectomy (TLH) using Olympus PK Morcellator in PneumoLiner containment device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The safety of using the PK MORCELLATOR in conjunction with the PneumoLiner containment device for contained cutting and extracting tissue during laparoscopic supracervical hysterectomy (LSH) or total laparoscopic hysterectomy (TLH). | The safety of using the PK MORCELLATOR within the PneumoLiner containment bag for cutting and extracting tissue during LSH or TLH procedure will be determined by the probability of failure during in-bag morcellation procedure. Failure is defined as disruption of the isolation bag (using dye leak testing) or visible tissue dissemination. Patient is defined success if no failure was detected as a result of the procedure. Study safety success will be declared if no more than 1 failure (bag rapture) will be observed in 140 procedures. | End of study - approximately two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The efficacy of using PK MORCELLATOR in conjunction with the PneumoLiner containment device | Ease of use of the PK MORCELLATOR in conjunction with the PneumoLiner containment device for LSH or TLH. Ease of use will be measured by designated Satisfaction Questionnaire. | End of study - approximately two years | 
| Intra- or post-operative complications | Intra or post complications rate (e.g. urinary, intestinal or nerve injury) | End of study - approximately two years | 
| Mean procedure time | Mean procedure time will be measured by hour/minutes. | End of study - approximately two years | 
| Estimated blood loss during operation | Blood loss during operation will be measured by volume (mL) | End of study - approximately two years | 
| Post-operative pain | Post-operative pain will be measured by Visual Analog Score - VAS | End of study - approximately two years | 
| Hospitalization length | Hospitalization length will be measured by days | End of study - approximately two years | 
| Specimen weight | Specimen will be measured by weight (gr) | End of study - approximately two years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gynecologic Surgery, larscopy, morcellation