Readmission Following Prostatic Surgery

October 20, 2023 updated by: Mansoura University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

4000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Mansoura, Egypt, 35516
        • Recruiting
        • Urology and nephrology center
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

They will be the subdivided into four groups:

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Transurethral incision of the prostate (TUIP)
Patients who underwent TUIP using electrocautery or Laser.
Procedure: TUIP
Patient who underwent transurethral incision of the prostate (TUIP) using electrical current or laser beam.
Transurethral resection of the prostate (TURP)
Patients who underwent TURP using monopolar or bipolar electrocautery.
Procedure: 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).
Procedure: Prostate Vaporization
Patient who underwent vaporization of the prostate using plasma or laser energy (GreenLight PVP and Thulium vaporization of the prostate).
Anatomical endoscopic enucleation of the prostate (AEEP)
Patient who underwent anatomical endoscopic enucleation of the prostate (AEEP) using Holmium, Thulium or GreenLight laser or bipolar current.
Procedure: AEEP
Patient who underwent anatomical endoscopic enucleation of the prostate (AEEP) using Holmium, Thulium or GreenLight laser or bipolar current.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The need for post discharge hospital readmission.
Time Frame: 90 days
The need for post discharge hospital readmission after surgery.
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differences of readmission rates
Time Frame: 90 days
Difference of readmission rates for different modalities of transuretheral prostatic surgery.
90 days
Change in the causes of readmission over time.
Time Frame: 20 years
Change in the causes of readmission over time.
20 years
Causes and predictors of readmission.
Time Frame: 90 days
Causes and predictors of readmission.
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Investigators

  • Principal Investigator: Ahmed R EL-Nahas, MD, Urology and nephrology center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2005

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

February 1, 2025

Study Registration Dates

First Submitted

October 20, 2023

First Submitted That Met QC Criteria

October 20, 2023

First Posted (Actual)

October 26, 2023

Study Record Updates

Last Update Posted (Actual)

October 26, 2023

Last Update Submitted That Met QC Criteria

October 20, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2436

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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