Clinical Trials Directory

Trials / Completed

CompletedNCT05941260

Standardization of Prostatic Resection by Virtual Computational Reconstruction and Computational Flow Dynamics

Standardization of Prostatic Resection Operative Techniques by Virtual Computational Reconstruction and Computational Flow Dynamics

Status
Completed
Phase
Study type
Observational
Enrollment
15 (actual)
Sponsor
Ain Shams University · Academic / Other
Sex
Male
Age
50 Years
Healthy volunteers
Not accepted

Summary

The enlargement of the prostate is responsible for voiding dysfunction in men, and especially elderly men. The primary surgical treatment for symptomatic benign prostatic hypertrophy (BPH) was transurethral resection of the prostate (TURP). However, current resection techniques are predominantly experience-based and judgment-based, with little evidence to support the most effective portion of the prostate to be respected. So, the investigators plan through the study to construct a flow diagram to evaluate the amount of tissue needed to be resected to improve voiding flow dynamics.

Detailed description

Benign prostatic hyperplasia (BPH) is an enlargement of the prostate gland that develops in men and is a common cause of voiding dysfunction in elderly patients. It is a major public health concern, causing high morbidity and substantial worsening of men's quality of life. (QOL) Transurethral resection of the prostate (TURP) is the standard surgical therapy for obstructive prostatic hypertrophy. Various techniques have been suggested for the systematic removal of the adenomatous tissue, all based on the principle that the resection should be done stepwise as bleeding is the surgeon's major problem, leading to loss of visual field and disorientation, it is imperative that resection and hemostasis should both be completed in one area of the prostatic fossa before the next area is tackled. With the development of new techniques for prostate resection that decreases perioperative morbidity, larger sizes of the prostate are being resected, and a new category of patients is considered eligible for such an intervention with a large prostate size of more than 80 gm. However, current resection techniques are predominantly experience-based and judgment-based, with little evidence to support the most effective portion of the prostate to be resected to give us the best voiding outcome postoperative. So, the investigators plan through this study to construct a flow diagram to evaluate the amount of tissue needed to be resected to improve voiding flow dynamics.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTComputational fluid dynamics (CFD)\- Video recording starts in an antegrade manner starting from the bladder neck through the prostatic urethra and ends after the verumontanum at the external sphincter. Videos were taken with a very slow movement of the endoscope to ensure the sharpness of the data and to prevent complications in post-processing. The focal length and zoom of the endoscope camera were set at the beginning and maintained throughout the capturing, while the angle of the lens changes to capture the widest field possible for each targeted area. * Computational fluid dynamics (CFD) can then be used to numerically model the behavior of the flow inside the urethra by solving the governing equations of the flow using the finite volume method. * Through which we can develop a urodynamic computer model to simulate the bladder-urethral passage and predict the success of the resection undertaken by the surgeon. No extra intervention will be provided to our patients apart from their routine surgery.

Timeline

Start date
2023-07-15
Primary completion
2023-07-30
Completion
2023-08-15
First posted
2023-07-12
Last updated
2024-05-08

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT05941260. Inclusion in this directory is not an endorsement.