Comparison of Different Energy Sources During TUR-P

Selcuk University

Status: Suspended

Conditions: Benign Prostatic Hypertrophy

Treatments: Procedure: Bipolar TURP-2; Procedure: Monopolar TURP; Procedure: Bipolar TURP-1

Study type: Interventional

Funder types: Other

Identifiers

NCT02533687

SU-TURP-BM-01

Details and patient eligibility

About

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.

Full 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

Enrollment: 90 estimated patients

Sex: Male

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 3 patient groups

Bipolar TURP-1

Active Comparator group

Description:

Transurethral resection of prostate (TURP) with bipolar resectoscope (Gyrus brand)

Treatment:

Procedure: Bipolar TURP-1

Bipolar TURP-2

Active Comparator group

Description:

TURP with bipolar resectoscope (Olympus brand)

Treatment:

Procedure: Bipolar TURP-2

Monopolar TURP

Active Comparator group

Description:

TURP with monopolar resectoscope (Karl Storz brand)

Treatment:

Procedure: Monopolar TURP