Clinical trial NCT03216772: Safety and Efficacy of Using PK Morcellator With Pneumoliner Containment Hysterectomy
Official title: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Gynecologic Surgery
Keywords: Gynecologic Surgery
larscopy
morcellation
Lead sponsor: Olympus Surgical Technologies Europe
Sponsor class: INDUSTRY
First posted: 2017-07-13
Enrollment: 0
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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)


Eligibility criteria: 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

Primary outcomes:
measure: 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).
timeFrame: End of study - approximately two years
Secondary outcomes:
measure: The efficacy of using PK MORCELLATOR in conjunction with the PneumoLiner containment device
timeFrame: End of study - approximately two years
measure: Intra- or post-operative complications
timeFrame: End of study - approximately two years
measure: Mean procedure time
timeFrame: End of study - approximately two years
measure: Estimated blood loss during operation
timeFrame: End of study - approximately two years
measure: Post-operative pain
timeFrame: End of study - approximately two years
measure: Hospitalization length
timeFrame: End of study - approximately two years
measure: Specimen weight
timeFrame: End of study - approximately two years
Other outcomes:
Locations:
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Erin Carey, MD
role: PRINCIPAL_INVESTIGATOR
References: