Comparison of Different Energy Sources During TUR-P

Study Overview
=================
Brief Summary
-----------------
With this study, it is aimed to compare the operative results and complication rates in transurethral resection of the prostate (TUR-P) performed by resectoscopes with two different bipolar and a monopolar energy sources.

Detailed Description
-----------------
Following data will be collected and evaluated prospectively for the three groups of patients who will undergo TUR-P due to benign prostate hyperplasia (BPH) with one of the resectoscopes using different energy sources: Preoperative data: age, height, weight, body-mass index, concomitant morbidities, use of any drug, history of operation, duration of lower urinary tract symptoms, history of any previous treatment taken for BPH, serum level of prostate specific antigen, prostate volume, maximum and average urine flow rate, postmicturation residual urine volume, hemoglobin level Operative data: duration of operation, volume of resected tissue, observation of obturator reflex (if any), kind and size of the urethral catheter used Postoperative data: time to removal of urethral catheter, hospitalization duration, change in hemoglobin, rate of blood transfusion, any other complications

Official Title
-----------------
Comparison of Two Different Bipolar and A Monopolar Energy Sources During Transurethral Resection of Prostate

Conditions
-----------------
Benign Prostatic Hypertrophy

Intervention / Treatment
-----------------
* Procedure: Bipolar TURP-1
* Procedure: Bipolar TURP-2
* Procedure: Monopolar TURP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Having an indication due to BPH Aged between 40 and 80 years old Exclusion Criteria: Kidney failure due to BPH Any kind of coagulopathy or use of anticoagulants in the preoperative period History of any previous open or endoscopic prostate surgery

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bipolar TURP-1<br>Transurethral resection of prostate (TURP) with bipolar resectoscope (Gyrus brand) | Procedure: Bipolar TURP-1<br>* Bipolar transurethral resection of prostate (TURP)<br>|
| Active Comparator: Bipolar TURP-2<br>TURP with bipolar resectoscope (Olympus brand) | Procedure: Bipolar TURP-2<br>* Bipolar TURP<br>|
| Active Comparator: Monopolar TURP<br>TURP with monopolar resectoscope (Karl Storz brand) | Procedure: Monopolar TURP<br>* Monopolar TURP<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uroflowmetry test | Determining the improvement in maximal urine flow (mL/s) and average urine flow (mL/s). | Within the first 30 days after surgery. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall complication rates | Number of patients with any complications related with TURP (including hemorrhage, blood transfusion, urinary tract infections, urethral strictures) classified according to modified Clavien-Dindo classification. | Within the first 30 days after surgery. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
prostate, transurethral resection, bipolar, monopolar