Randomized Controlled Trial Comparing Two Different Morcellators for HoLEP Procedures

Not Applicable

Completed

• Conditions: Benign Prostatic Hypertrophy Requiring Surgical Intervention
• Interventions: Device: Wolf Piranha Morcellator; Device: Lumenis VersaCut Morcellator

• Registration Number: NCT02195622
• Lead Sponsor: Indiana Kidney Stone Institute

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

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2014-07-17
• Study First Submitted QC: 2014-07-17
• Study First Posted: 2014-07-21
• Primary Completion: 2015-01
• Study Completion: 2016-02
• Results First Submitted: 2018-06-20
• Status Verified: 2019-03
• Results First Submitted QC: 2019-03-08
• Last Update Submitted: 2019-03-08
• Results First Posted: 2019-03-11
• Last Update Posted: 2019-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 74

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Wolf Piranha Morcellator	Wolf Piranha Morcellator	Wolf Piranha Morcellator will be utilized for prostate tissue morcellation
Lumenis VersaCut Morcellator	Lumenis VersaCut Morcellator	Lumenis VersaCut Morcellator will be utilized for prostate tissue morcellation

Primary Outcome Measures

Name	Time	Method
Morcellation Rate	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."

Trial Locations

Locations (1)

IU Health Physicians Urology; 🇺🇸 Indianapolis, Indiana, United States