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)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Laparoscopic Supracervical Hysterectomy (LSH) or Total Laparoscopic Hysterectomy (TLH) using Olympus PK Morcellator in PneumoLiner containment device
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.
Time frame: End of study - approximately two years
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.
Time frame: End of study - approximately two years
Intra- or post-operative complications
Intra or post complications rate (e.g. urinary, intestinal or nerve injury)
Time frame: End of study - approximately two years
Mean procedure time
Mean procedure time will be measured by hour/minutes.
Time frame: End of study - approximately two years
Estimated blood loss during operation
Blood loss during operation will be measured by volume (mL)
Time frame: End of study - approximately two years
Post-operative pain
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Post-operative pain will be measured by Visual Analog Score - VAS
Time frame: End of study - approximately two years
Hospitalization length
Hospitalization length will be measured by days
Time frame: End of study - approximately two years
Specimen weight
Specimen will be measured by weight (gr)
Time frame: End of study - approximately two years