Comparison of Different Energy Sources During TUR-P

Not Applicable

Suspended

• Conditions: Benign Prostatic Hypertrophy
• Interventions: Procedure: Bipolar TURP-1; Procedure: Bipolar TURP-2; Procedure: Monopolar TURP

• Registration Number: NCT02533687
• Lead Sponsor: Selcuk University

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:

1. 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

2. Operative data: duration of operation, volume of resected tissue, observation of obturator reflex (if any), kind and size of the urethral catheter used

3. Postoperative data: time to removal of urethral catheter, hospitalization duration, change in hemoglobin, rate of blood transfusion, any other complications

Study Timeline

• Study First Submitted: 2015-08-23
• Study First Submitted QC: 2015-08-24
• Study First Posted: 2015-08-27
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-15
• Last Update Posted: 2019-11-19
• Study Start: 2020-07
• Primary Completion: 2020-07
• Study Completion: 2020-10

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: Male
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bipolar TURP-1	Bipolar TURP-1	Transurethral resection of prostate (TURP) with bipolar resectoscope (Gyrus brand)
Bipolar TURP-2	Bipolar TURP-2	TURP with bipolar resectoscope (Olympus brand)
Monopolar TURP	Monopolar TURP	TURP with monopolar resectoscope (Karl Storz brand)

Primary Outcome Measures

Name	Time	Method
Uroflowmetry test	Within the first 30 days after surgery.	Determining the improvement in maximal urine flow (mL/s) and average urine flow (mL/s).

Secondary Outcome Measures

Name	Time	Method
Overall complication rates	Within the first 30 days after surgery.	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.

Trial Locations

Locations (1)

Selcuk University, School of Medicine, Department of Urology; 🇹🇷 Konya, Turkey