Safety and Efficacy of Using PK Morcellator With Pneumoliner Containment Hysterectomy

Not Applicable

Withdrawn

• Conditions: Gynecologic Surgery
• Interventions: Device: Olympus PK Morcellator in PneumoLiner

• Registration Number: NCT03216772
• Lead Sponsor: Olympus Surgical Technologies Europe

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)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-07-08
• Study First Submitted QC: 2017-07-12
• Study First Posted: 2017-07-13
• Study Start: 2018-01-20
• Primary Completion: 2021-09
• Study Completion: 2022-02
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-07
• Last Update Posted: 2022-07-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Olympus PK Morcellator in PneumoLiner	Olympus PK Morcellator in PneumoLiner	Laparoscopic Supracervical Hysterectomy (LSH) or Total Laparoscopic Hysterectomy (TLH) using the Olympus PK Morcellator in PneumoLiner containment device

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Intra- or post-operative complications	End of study - approximately two years	Intra or post complications rate (e.g. urinary, intestinal or nerve injury)
Hospitalization length	End of study - approximately two years	Hospitalization length will be measured by days
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)
Post-operative pain	End of study - approximately two years	Post-operative pain will be measured by Visual Analog Score - VAS
Specimen weight	End of study - approximately two years	Specimen will be measured by weight (gr)
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.