TURP; Complications and Outpatient Care

Benign Prostatic Hyperplasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03959917
• Other study ID #: EPN 201801-12
• Status: Recruiting
• Start date: May 15, 2019
• Est. completion date: September 30, 2020

Study information

• Verified date: May 2019
• Source: Umeå University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 30, 2020
• Est. primary completion date: February 15, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• No consent to participate

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Prostatic Hyperplasia

Intervention

Procedure:
• transurethral resection of the prostate
Surgical removal of benign prostatic tissue

Locations

Country	Name	City	State
Sweden	Östersunds hospital	Östersund	Jämtland

Sponsors (1)

Lead Sponsor	Collaborator
Umeå University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients able to be discharged the day of surgery		One day
Primary	Proportion of patients readmitted to hospital the first day of surgery		One day
Secondary	Change in IPSS score	International prostate symptom score, range 0-35	6 months
Secondary	Number of patients with cancer in surgical specimen	Pathological confirmed prostate cancer, all Gleasson Grades (6-10)	6 months
Secondary	Readmission rates within 30 days of surgery		30 days
Secondary	Complications	Clavien Dindo Classification	30 days
Secondary	Proportion catheter free		6 months