Comparison of Two Different Bipolar and A Monopolar Energy Sources During Transurethral Resection of Prostate
Trial Snapshot
- Phase
- Not Applicable
- Status
- Suspended
- Sponsor
- Selcuk University
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Uroflowmetry test
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to 80 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Bipolar TURP-1
Transurethral resection of prostate (TURP) with bipolar resectoscope (Gyrus brand)
Intervention: Bipolar TURP-1 (Procedure)
Bipolar TURP-2
TURP with bipolar resectoscope (Olympus brand)
Intervention: Bipolar TURP-2 (Procedure)
Monopolar TURP
TURP with monopolar resectoscope (Karl Storz brand)
Intervention: Monopolar TURP (Procedure)
Outcomes
Primary Outcomes
Uroflowmetry test
Time Frame: Within the first 30 days after surgery.
Determining the improvement in maximal urine flow (mL/s) and average urine flow (mL/s).
Secondary Outcomes
- Overall complication rates(Within the first 30 days after surgery.)
Investigators
Murat AKAND
Assistant Professor, M.D.
Selcuk University