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Prostate Single Port & Laser Enucleation Comparison Trial

NCT06224218 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 116

Last updated 2024-05-16

No results posted yet for this study

Summary

Surgical treatments for benign prostatic hyperplasia (BPH) are necessary when non-procedural approaches fail to alleviate lower urinary tract symptoms (LUTS) or bladder outlet obstruction (BOO). Open simple prostatectomy and laser enucleation are recommended for prostatic adenoma size greater than 80 ml. Minimally invasive approaches, such as robotic-assisted simple prostatectomy, have gained popularity due to their comparable outcomes with lower morbidity. The introduction of the da Vinci single-port (SP) robotic platform offers potential advantages, but its outcomes have not been thoroughly investigated.

This randomized controlled trial aims to compare the outcomes of SP simple prostatectomy performed using the da Vinci robotic platform versus thulium laser enucleation of the prostate for the treatment of BPH and BOO.

Conditions

  • Prostate Hyperplasia

Interventions

PROCEDURE

Single Port Robotic Surgery

Single port Robotic surgery will remove the whole prostate

PROCEDURE

Laser Surgery

Laser enucleation will remove chips of the prostate but keeping intact the prostate capsule.

Sponsors & Collaborators

  • University of Illinois at Chicago

    lead OTHER

Principal Investigators

  • Simone Crivellaro, MD · University of Illinois at Chicago, Department of Urology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
88 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-15
Primary Completion
2027-01-15
Completion
2027-08-15

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06224218 on ClinicalTrials.gov