Comparison of Different Energy Sources During TUR-P

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-31

Study Completion Date

2020-10-31

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Benign Prostatic Hypertrophy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Bipolar TURP-1

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

Group Type ACTIVE_COMPARATOR

Bipolar TURP-1

Intervention Type PROCEDURE

Bipolar transurethral resection of prostate (TURP)

Bipolar TURP-2

TURP with bipolar resectoscope (Olympus brand)

Group Type ACTIVE_COMPARATOR

Bipolar TURP-2

Intervention Type PROCEDURE

Bipolar TURP

Monopolar TURP

TURP with monopolar resectoscope (Karl Storz brand)

Group Type ACTIVE_COMPARATOR

Monopolar TURP

Intervention Type PROCEDURE

Monopolar TURP

Interventions

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Bipolar TURP-1

Bipolar transurethral resection of prostate (TURP)

Intervention Type PROCEDURE

Bipolar TURP-2

Bipolar TURP

Intervention Type PROCEDURE

Monopolar TURP

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No