Trials / Unknown
UnknownNCT05784181
Bipolar Versus Laser Enaculation of Prostate for >80gram Prostate .
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- Sponsor
- Menoufia University · Academic / Other
- Sex
- Male
- Age
- 40 Years
- Healthy volunteers
- Accepted
Summary
Transurethral resection of the prostate (TURP ) still the gold standerad for surgical management of enlarged prostate .However , many minimally invasive procedures are now in the comparative track with Bipolar resection as Laser enaculation. Holmium laser prostatectomy was introduced since 1994 . different types of uses by laser were introduced either resection or enaculation with good outcomes and less complications . One of the most important issues related to large prostate management is the retreatment after Bipolar resection , another issue that prolonged catheter time post resection .
Detailed description
Transurethral resection of the prostate (TURP ) still the gold standerad for surgical management of enlarged prostate .However , many minimally invasive procedures are now in the comparative track with Bipolar resection as Laser enaculation. Holmium laser prostatectomy was introduced since 1994 . different types of uses by laser were introduced either resection or enaculation with good outcomes and less complications . One of the most important issues related to large prostate management is the retreatment after Bipolar resection , another issue that prolonged catheter time post resection , so , we try to analyze the effect of Laser enaculation of the prostate in comparison to Bipolar resection in prostate more than 80 gm . Aim of the work: Aim of the work is to compare the efficacy of Bipolar versus Laser enaculation of prostate for \>80gram. Patients and Methods: A randomized comparative study will be conducted at Menoufia university hospital , urology department. patients will be selected after informed consent. Inclusion criteria: similar for all patients prostatic volume more than 80 gm , peak urinary flow rate measurement (Qmax) \<15 ml/s, International Prostate Symptom Score (IPSS) of \>8 , postvoid residual (PVR) \<400 ml. Exclusion criteria: Patients with prostate size less than 80gm , urethral stricture, acute urinary tract infection, repeated treatment . Preoperatively, all the patients will undergo thorough process of history taking , clinical examination, and investigations in the form of abdominopelvic and trans rectal ultrasonography , PSA ,urine analysis, urine culture if needed and routine pre-operative lab investigations as (CBC , PT, LFTs, serum creatinine and RBS). The treatment modality chosen for an individual will be randomized . All patients with positive urine culture will be treated by proper antibiotics before the procedures. Peri-operatively , all patients will receive a single shot of pre-operative antibiotic. For the first group patients transurethral resection of prostate For the second group patients Laser enaculation by holmium: YAG laser Postoperatively, patients will undergo IPSS score , flowmetry post operative after 3months .
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | bipolar transurethral resection and Laser enaculation by holmium: YAG laser | Laser enaculation by holmium: YAG laser |
Timeline
- Start date
- 2021-10-01
- Primary completion
- 2024-07-01
- Completion
- 2024-12-01
- First posted
- 2023-03-24
- Last updated
- 2024-01-03
Locations
1 site across 1 country: Egypt
Source: ClinicalTrials.gov record NCT05784181. Inclusion in this directory is not an endorsement.