Randomized Controlled Trial Comparing Two Different Morcellators for HoLEP Procedures
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Benign Prostatic Hypertrophy Requiring Surgical Intervention
- Sponsor
- Indiana Kidney Stone Institute
- Enrollment
- 74
- Locations
- 1
- Primary Endpoint
- Morcellation Rate
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
To compare efficiency, in terms of tissue morcellation and removal time, of two commercially available FDA-approved morcellators: the VersaCut and the Piranha in subjects undergoing HoLEP procedure for benign prostatic hyperplasia (BPH).
Detailed Description
Holmium laser enucleation of the prostate (HoLEP) with mechanical morcellation is a surgical technique used for treatment of bladder outlet obstruction (BOO) secondary to benign prostatic hyperplasia (BPH). HoLEP represents a state of the art alternative to transurethral resection of the prostate (TURP). HoLEP has been shown to be safe and effective for treating prostates of all sizes and has low perioperative morbidity. A holmium laser fiber is passed through a continuous-flow resectoscope and is used to resect the obstructing prostate tissue (enucleation). After enucleation is performed, the resected tissue is advanced into the bladder. The morcellator is then used to cut the tissue into small pieces which are then removed from the bladder via suction through the morcellator blades (morcellation). We currently use the first commercially available morcellator (VersaCut, Lumenis Incorporated, Santa Clara, CA). The Storz continuous-flow resectoscope (Karl Storz,Tuttlingen, Germany) is currently used to perform the enucleation portion of the procedure. Recently, a new morcellator has been developed (Piranha, Richard Wolf, Knittlingen, Germany). The Wolf morcellator has been reported to remove tissue at a faster rate than the Lumenis device
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients scheduled to undergo HoLEP for bladder outlet obstruction due to the prostate.
- •Able to give informed consent.
- •Age 18 years or older
Exclusion Criteria
- •• Inability to give informed consent.
- •Age less than 18 years
Outcomes
Primary Outcomes
Morcellation Rate
Time Frame: Collected intraoperatively upon completion of enucleation (surgical removal) of the extra benign prostate tissue growth
Operatively, the amount of enucleated tissue removed (in grams) per the time for complete removal (in minutes) will be recorded as "morcellation rate."