Gynecologic Surgery
Conditions
Keywords
Gynecologic Surgery, larscopy, morcellation
Brief summary
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)
Interventions
DEVICEOlympus PK Morcellator in PneumoLiner
Laparoscopic Supracervical Hysterectomy (LSH) or Total Laparoscopic Hysterectomy (TLH) using Olympus PK Morcellator in PneumoLiner containment device
Sponsors
Olympus Surgical Technologies Europe
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
35 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). | End of study - approximately two years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intra- or post-operative complications | End of study - approximately two years | Intra or post complications rate (e.g. urinary, intestinal or nerve injury) |
| Mean procedure time | End of study - approximately two years | Mean procedure time will be measured by hour/minutes. |
| Estimated blood loss during operation | End of study - approximately two years | Blood loss during operation will be measured by volume (mL) |
| The efficacy of using PK MORCELLATOR in conjunction with the PneumoLiner containment device | End of study - approximately two years | 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. |
| Hospitalization length | End of study - approximately two years | Hospitalization length will be measured by days |
| Specimen weight | End of study - approximately two years | Specimen will be measured by weight (gr) |
| Post-operative pain | End of study - approximately two years | Post-operative pain will be measured by Visual Analog Score - VAS |
Outcome results
None listed