HoLEP Vs BPEP for Large Prostatic Adenoma
- Conditions
- Prostate Hyperplasia
- Interventions
- Procedure: Holmium laser enucleation of the prostate versus bipolar transurethral enucleation of the prostate in management of benign prostatic hyperplasia
- Registration Number
- NCT04275076
- Lead Sponsor
- Ahmed Maher Gamil Ahmed Higazy
- Brief Summary
Benign prostatic hyperplasia (BPH) is one of the most common urinary disorders in elderly males. The symptoms of BPH include impaired physiological and functional well-being, which interferes with daily living.
At present, transurethral resection of the prostate (TURP) is the standard surgical treatment. However, the high rate of complications associated with TURP is a major drawback of this procedure.
Holmium laser enucleation of the prostate (HoLEP) was proven to be an effective surgical treatment for BPH with no prostate size limitation with adequate hemostasis, bipolar enucleation of the prostate (BPEP) has been introduced as an alternative energy source with a promising outcome with equal safety and efficacy
- Detailed Description
Enlarged prostate represents the most common cause of lower urinary tract symptoms (LUTS) in elderly men including irritative, obstructive urinary symptoms or even urinary retention that significantly affects the quality life (QoL).
Transurethral resection of the prostate (TURP) represents the standard surgical technique for the management of benign prostatic hyperplasia (BPH) with a prostate size less than 80 ml. However, considerable morbidities are associated with larger sizes.
Endoscopic enucleation of the prostate (EEP) has been recognized as a treatment option for large prostatic adenomas, since first described by Hiraoka et.al, in 1986, it started to gain popularity despite the long learning curve. Many studies have evaluated its efficacy against the gold standard open prostatectomy in large prostate size more than 80ml and showed its safety and efficacy.
EEP represents an anatomical surgical technique resembling a surgeon's finger in open prostatectomy where any energy source that provides adequate haemostasis could be used. Many studies concluded that EEP relies on the surgeon's skills rather than the energy source itself. Holmium laser enucleation of the prostate (HoLEP) was first described by Gilling in 1998 and was proven to be effective with no prostate size limitation with adequate haemostasis, recently it has been approved as a standard treatment for large prostatic adenoma, bipolar enucleation of the prostate (BPEP) has been introduced as an alternative energy source with a promising outcome with equal safety and efficacy.
Few studies evaluated both techniques, one study was done by Shoma et al. showing no statistical difference regarding safety and efficacy between both techniques, another study conducted by Enikeev et al. reported earlier recovery and catheter removal with HoLEP compared to BPEP. However, cost-effectiveness was never been evaluated before between both techniques especially in developing countries.
With such scarce information, the investigators aimed through this study to compare these two energy sources in the enucleation procedure of the prostate in terms of safety, efficacy, and cost-effectiveness in the management of BPH in large prostatic adenoma more than 80 ml.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 100
-
Men who are fit for surgery and need a surgical resection of the prostate larger than 80 ml including:
- Bothersome LUTS with an IPSS score over 19
- Refractory hematuria
- Upper urinary tract affection
- Recurrent UTI secondary to prostatic enlargement
- Maximum uroflow rate (Qmax) below 10 ml/sec.
- bladder diverticula
- Urinary retention whether recurrent acute attacks with failure of medical treatment or chronic retention.
-
Patients with:
- Neurogenic bladder
- Previous prostate or urethral surgery
- Associated urethral stricture
- Prostate cancer diagnosed by TRUS biopsy
- Bladder stones,
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Holmium laser enucleation of the prostate Holmium laser enucleation of the prostate versus bipolar transurethral enucleation of the prostate in management of benign prostatic hyperplasia Holmium laser enucleation of the prostate bipolar transurethral enucleation of the prostate Holmium laser enucleation of the prostate versus bipolar transurethral enucleation of the prostate in management of benign prostatic hyperplasia bipolar transurethral enucleation of the prostate
- Primary Outcome Measures
Name Time Method operative time 50-120 minutes form the beginning of endoscopic procedure till catheter insertion
- Secondary Outcome Measures
Name Time Method irrigation fluid intra-operative finding Average Irrigation fluid used in each group in liters
Postoperative efficacy: 12 months postoperative prostate volume assessment in grams
Cost analysis 1 year average running cost evaluation in both procedure
Enucleation efficacy of HoLEP 12 months Mean Enucleation time (HoLEP) in minutes divided by Mean resected volume in grams
Enucleation efficacy of BEEP 12 months Mean Enucleation time (BPEP) in minutes/ Mean resected volume in grams
resected volume intra-operative finding resected volume in grams
Operative safety: intra-operative finding morcellation injury, Yes/No
Mean energy in (HoLEP) in joules intra-operative finding Mean energy in (HoLEP) in joules
catheter removal time 1-7 days postoperative time till catheter removal
hemoglobin drop intra-operative finding blood loss in dl/ml
conversion to other type of surgery intra-operative finding conversion to other types of surgeries like TURP, open surgery, procedure abortion
cost effectiveness 12 months Running cost in Egyptian pounds of the following: irrigation fluid, hospital stay, fiber, loop, management of complication in each group
hospital stay 1-7 days duration of postoperative hospital stay in days
early post operative complication 1 month urine retention, Yes/No
Trial Locations
- Locations (1)
Ain Shams University Hospitals
🇪🇬Cairo, Egypt