Readmission Following Prostatic Surgery

BPH With Urinary Obstruction Clinical Trial

Official title:

Readmission Following Endourological Prostatic Surgery for Benign Prostatic Obstruction: Review of 20 Years of Experience

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06101576
• Other study ID #: 2436
• Status: Recruiting
• Start date: January 1, 2005
• Est. completion date: February 1, 2025

Study information

• Verified date: October 2023
• Source: Mansoura University
• Contact: Ahmed R EL-Nahas, MD
• Phone: +201221136899
• Email: ar_el_nahas[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study will be conducted to estimate readmission rate and reasons for readmission after all modalities of endoscopic transurethral surgeries for treatment of BOO secondary to BPH in the last 20 years.

Description:

Computerized patient information system (PIS) of Urology and Nephrology Center (UNC) and database of prostate unit of UNC will be reviewed for all preoperative, intraoperative and post discharge data. All follow up visits will be traced for outcome measurement. Patients with no hospital follow up visit will be contacted by phone and interrogated about their LUTS control state, ongoing medication and history of secondary procedures.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4000
• Est. completion date: February 1, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

Men who underwent transurethral prostatic surgery for BPH causing BOO at Urology and Nephrology Center, Mansoura University, Egypt from Jun. 2005 to Dec. 2024.

Exclusion Criteria:

1. Patients who underwent TUR tunnelling for prostatic adenocarcinoma.

2. LUTS secondary to neuropathic bladder.

3. Incidentally diagnosed prostate cancer after surgery

Related Conditions & MeSH terms

• BPH With Urinary Obstruction

Intervention

Procedure:
• TUIP
Patient who underwent transurethral incision of the prostate (TUIP) using electrical current or laser beam.
• TURP
Patient who underwent transurethral resection of the prostate (TURP) using momopolar or bipolar current.
• Prostate Vaporization
Patient who underwent vaporization of the prostate using plasma or laser energy (GreenLight PVP and Thulium vaporization of the prostate).
• AEEP
Patient who underwent anatomical endoscopic enucleation of the prostate (AEEP) using Holmium, Thulium or GreenLight laser or bipolar current.

Locations

Country	Name	City	State
Egypt	Urology and Nephrology Center	Mansoura

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The need for post discharge hospital readmission.	The need for post discharge hospital readmission after surgery.	90 days
Secondary	Differences of readmission rates	Difference of readmission rates for different modalities of transuretheral prostatic surgery.	90 days
Secondary	Change in the causes of readmission over time.	Change in the causes of readmission over time.	20 years
Secondary	Causes and predictors of readmission.	Causes and predictors of readmission.	90 days