Urological and Genital Diseases
Conditions
Interventions
Morcellation after prostatic enucleation using the Drillcut morcellation system
Morcellation after prostatic enucleation using the Cyberblade morcellation system
Morcellation after prostatic enucleation using the Hawk jaws morcellation system
Sponsors
Faculty of Medicine Tanta University
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Male patients aged =45 years Symptomatic benign prostatic hyperplasia with: International Prostate Symptom Score (IPSS) =13, OR Maximum urinary flow rate (Qmax) <12 mL/s with voided volume =125 mL, OR Refractory urinary retention requiring chronic catheterization Prostate volume =40 mL (measured by transrectal ultrasound or MRI) Failed medical management or contraindication to medical therapy Scheduled for elective endoscopic enucleation of the prostate (HoLEP, ThuLEP, or BiEP) American Society of Anesthesiologists (ASA) physical status I-III Able to provide written informed consent Willing and able to comply with follow-up requirements
Exclusion criteria
Exclusion criteria: Known or suspected prostate cancer (PSA >10 ng/mL with abnormal DRE or prior positive biopsy) Active urinary tract infection at time of surgery Neurogenic bladder dysfunction Bladder cancer (current or within 2 years) Urethral stricture disease requiring intervention Previous prostate surgery (TURP, open prostatectomy, laser ablation) ASA physical status IV or V Uncorrected coagulopathy (INR >1.5, platelets <50,000) Inability to discontinue anticoagulation perioperatively Participation in another interventional trial within 30 days Bladder stones requiring separate lithotripsy Active malignancy under treatment Intraoperative Exclusion Criteria Conversion to alternative procedure (TURP, open surgery) Incomplete enucleation preventing morcellation Significant bleeding requiring early termination Equipment failure of primary enucleation device requiring prolonged delay
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the morcellation efficiency of the mentioned morcellators. Morcellation efficiency will be calculated as the morcellated prostate weight divided by morcellation time. | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare total morcellation time between the three devices To assess the rate of bladder mucosal injury associated with each device To compare the completeness of tissue retrieval (residual prostatic fragments) To evaluate device-related complications and technical malfunctions To compare total operative time and energy source usage To assess surgeon learning curve and ease of use To assess cost-effectiveness including device costs and operative efficiency | — |
Countries
Egypt
Contacts
Public ContactAhmed Eissa
Lecturer of Urology
Outcome results
None listed