TURP; Complications and Outpatient Care

• Conditions: Benign Prostatic Hyperplasia

• Registration Number: NCT03959917
• Lead Sponsor: Umeå University

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.

Study Timeline

• Status Verified: 2019-05
• Study Start: 2019-05-15
• Study First Submitted: 2019-05-21
• Study First Submitted QC: 2019-05-21
• Study First Posted: 2019-05-22
• Last Update Submitted: 2019-05-23
• Last Update Posted: 2019-05-24
• Primary Completion: 2020-02-15
• Study Completion: 2020-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 50

Inclusion Criteria

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

Exclusion Criteria

• No consent to participate

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients able to be discharged the day of surgery	One day
Proportion of patients readmitted to hospital the first day of surgery	One day

Secondary Outcome Measures

Name	Time	Method
Readmission rates within 30 days of surgery	30 days
Proportion catheter free	6 months
Change in IPSS score	6 months	International prostate symptom score, range 0-35
Number of patients with cancer in surgical specimen	6 months	Pathological confirmed prostate cancer, all Gleasson Grades (6-10)
Complications	30 days	Clavien Dindo Classification

Trial Locations

Locations (1)

Östersunds hospital; 🇸🇪 Östersund, Jämtland, Sweden