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The aim of this study is to compare the success rate of outpatient surgery after holmium LASER enucleation of the prostate (HoLEP) for the treatment of BPH with and without the use of the MOSES 2.0 effect.
HoLEP is in the process of becoming the new reference surgical treatment for BPH with the main advantages over monopolar transurethral resection (TURPm) and high approach adenomectomy (AVH): the significant reduction in morbidity perioperative period and therefore the reduction in the length of hospital stay. This reduction in length of stay has led to the development of outpatient care with encouraging results. The main cause of discharge failure on D0 is the persistence of postoperative hematuria requiring maintenance of bladder irrigation. MOSESTM 2.0 technology has the advantage of better hemostasis compared to the LASER LP100 currently used. The objective of this study is to evaluate the influence of MOSESTM 2.0 technology on the outpatient success rate in patients operated on for HoLEP for BPH.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HoLEP patients without MOSESTM 2.0 effect (open label) | control retrospective open label |
| |
| HoLEP patients with MOSESTM 2.0 effect (open label) | prospective open label |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HoLEP patients without MOSES(TM) 2.0 effect (open label) | Procedure | HoLEP surgery for the treatment of Benign Prostate Hyperthrophy, without using MOSES technology |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patient who discharge on D0 (same day of his surgery) | baseline | |
| Number of hour's hospitalization | baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Number of hour's surgery time | baseline | |
| Rate of enucleated prostate tissue By time treatment per patient | baseline | |
| number of minutes use of the LASER during surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Grégoire ROBERT, PU-PH | University Hospital Bordeaux, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Bordeaux | Bordeaux | 33075 | France |
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| HoLEP patients with MOSES(TM) 2.0 effect (open label) | Procedure | HoLEP surgery for the treatment of Benign Prostate Hyperthrophy, with the use of MOSES technology |
|
| baseline |
| quantity of energy used during the intervention per patient | baseline |
| Intraoperative transfusion rate | baseline |
| Duration of post-operative sounding (hours) | baseline |
| Readmission rate within 48 hours of discharge from hospital | baseline |
| Mean change in IPSS before surgery and 3 months after surgery | 3 months after surgery |
| Mean change in QoL before surgery and 3 months after surgery | 3 months after surgery |
| Mean change in IIEF-5 before surgery and 3 months after surgery | 3 months after surgery |
| Mean change in ICIQ-short form score before surgery and 3 months after surgery | 3 months after surgery |
| Mean change in USP before surgery and 3 months after surgery | 3 months after surgery |
| Mean evolution of Qmax and post-void residual (RPM) before the intervention and at 3 months post-operative | 3 months after surgery |
| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| D018761 | Multiple Endocrine Neoplasia Type 1 |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D009377 | Multiple Endocrine Neoplasia |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009378 | Neoplasms, Multiple Primary |
| D009386 | Neoplastic Syndromes, Hereditary |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D004700 | Endocrine System Diseases |
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