Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06546865
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-30
Brief Title:
Slim Sheath 22F Holmium Laser Enucleation of the Prostate HoLEP vs 26 F Sheath HoLEP for BPH RCT
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Slim Sheath 22F Holmium Laser Enucleation of the Prostate HoLEP Technique vs 26 F Sheath HoLEP for Treatment of Benign Prostatic Hyperplasia BPH A Randomized Prospective Comparative Study
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Holmium laser enucleation of the prostate HoLEP is routinely performed with 24F 26F and 28F laser scopes Proponents of larger caliber scopes suggest that the larger scope size allows for improved visualization hemostasis and operative efficiencies Proponents of a smaller scope diameter suggest that by eliminating the need for pre-HoLEP urethral dilation to accommodate a larger scope It has also been proposed that a smaller caliber scope is less traumatic to the urethra resulting in lower rates of bladder neck contracture and urethral stricture disease Currently to our knowledge there are no level one evaluation examining scope size 22F versus 26F sheath in laser enucleation outcomes The aim of our study is to determine if a smaller diameter scope is associated with improved laser enucleation time post-operative recovery rates of same-day discharge or increasing intra-operative or postoperative complication rates
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None