Bipolar Enucleation of the Prostate Versus Bipolar TURP (TURP)
A Comparative Study Of Clinical Outcomes Of Bipolar Enucleation Of The Prostate Versus Bipolar TURP In Management Of Benign Prostatic Hyperplasia : A Randomized Controlled Clinical Trial
調査の概要
詳細な説明
Recent literature suggests that enucleation techniques may provide superior functional results, reduced bleeding, and lower retreatment rates. Nevertheless, there remains limited high-quality randomized controlled data directly comparing bipolar TURP and bipolar enucleation of prostate as a head to head comparison regarding functional outcomes and peri-operative complications.
In this study, a randomized controlled trial was performed to compare bipolar enucleation of the prostate versus bipolar transurethral resection of the prostate in BPH regarding symptoms relief, residual adenoma, urine flow rate and post-operative morbidity.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Cairo Governorate
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Cairo、Cairo Governorate、エジプト、11566
- Ain Shams University Hospitals
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- All male patients above the age of 40 years who presented to the urology clinic in Ain Shams university hospitals with BPH with prostate size 80 - 120 g and have any of the following criteria:
- Voiding symptoms that are poorly responsive to medical treatment (IPSS more than 18 and Qmax less than 15 ml/sec)
- Persistent or recurrent attacks of urine retention due to BPH.
- Large bladder stones from BPH.
- Recurrent UTI due to BPH.
- Severe gross hematuria from BPH.
Exclusion Criteria:
- Patients with untreated or active UTI.
- Previous pelvic radiation or pelvicl trauma.
- Patients with anesthesia contraindications such as uncontrolled diabetes mellitus, severe coagulation disorders and severe cardiac diseases.
- Known or suspected neurogenic bladder.
- Urethral stricture or urethral cancer.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：bipolar TURP
transurethral resection of the prostate by bipolar current
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transurethral resection of the prostate by bipolar current
他の名前：
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アクティブコンパレータ：BEEP
endoscopic enucleation of the prostate by bipolar current
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endoscopic enucleation of the prostate by bipolar current
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
volume of residual prostatic adenoma
時間枠：one month postoperative
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measurement of volume of residual prostatic adenoma post bipolar TURP and BEEP was done by pelvi-abdominal ultrasound
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one month postoperative
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change in international prostate symptoms score
時間枠：pre-operative, one, three, six and twelve months postoperative
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The international prostate symptoms score is a patient-completed questionnaire for standardized assessment of lower urinary tract symptoms (LUTS). It includes seven questions that evaluate the following urinary symptoms:
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pre-operative, one, three, six and twelve months postoperative
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improvement in maximum urine flow rate(Q max)
時間枠：pre-operative, 1, 3, 6 and 12 months postoperative
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Maximum urine flow rate was evaluated by Uroflowmetry
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pre-operative, 1, 3, 6 and 12 months postoperative
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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reduction in post voiding residual urine
時間枠：pre-operative, 1, 3, 6 and 12 months postoperative
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post voiding residual urine in bladder was evaluated by Trans-abdominal ultrasound
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pre-operative, 1, 3, 6 and 12 months postoperative
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operation time
時間枠：during operation
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Operation time was calculated from insertion of the cystoscope/resectoscope into the urethra to final removal of the scope
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during operation
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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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