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Clinical Trials/NCT03959917
NCT03959917
Unknown
Not Applicable

Bipolar Transurethral Resection of the Prostate; Complications and Possibility to do as Outpatient Procedure

Umeå University1 site in 1 country50 target enrollmentMay 15, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Benign Prostatic Hyperplasia
Sponsor
Umeå University
Enrollment
50
Locations
1
Primary Endpoint
Proportion of patients readmitted to hospital the first day of surgery
Last Updated
6 years ago

Overview

Brief Summary

This study aims to investigate the impact of transurethral prostate resection in regard to complications. These are direct surgical complications, such as bleeding, infection and readmissions, as well as the long term complications as incontinence and impotence. Also, the study aims to investigate if selected cases of patients could be performed as outpatient surgery, thereby reducing cost.

Detailed Description

Transuretral prostate resection (TUR P) is a common procedure to relieve voiding problems in men. After the introduction of bipolar resection with saline, the serious complication of transurethral resection syndrome (i.e. acute hypo-natremia) has been eradicated. The post surgical care is generally a couple of days inhospital care. The reson for this, is the risk of clot formation and in rare cases post surgical infection. However, in selected cases, outpatient surgery has been performed with encouraging results. However, the technique has not been spread widely. The use of ambulatory surgery would reduce the direct cost of the procedure, thereby increasing it´s availability. Also, complications in contemporary TUR P in the modern era (outside of the selected patients of clinical trials) is lacking. The information of complications that can be expected is therefore an important for patient counseling. In some studies, the use of incontinence pads after TUR P is more than 15%, which is important to reliably ascertain if this is holds true.

Registry
clinicaltrials.gov
Start Date
May 15, 2019
End Date
September 30, 2020
Last Updated
6 years ago
Study Type
Observational
Sex
Male

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Planned for transurethral resection of the prostate (TUR P)

Exclusion Criteria

  • No consent to participate

Outcomes

Primary Outcomes

Proportion of patients readmitted to hospital the first day of surgery

Time Frame: One day

Proportion of patients able to be discharged the day of surgery

Time Frame: One day

Secondary Outcomes

  • Readmission rates within 30 days of surgery(30 days)
  • Proportion catheter free(6 months)
  • Change in IPSS score(6 months)
  • Number of patients with cancer in surgical specimen(6 months)
  • Complications(30 days)

Study Sites (1)

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