TURP; Complications and Outpatient Care
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|ClinicalTrials.gov Identifier: NCT03959917|
Recruitment Status : Recruiting
First Posted : May 22, 2019
Last Update Posted : May 24, 2019
|Condition or disease||Intervention/treatment|
|Benign Prostatic Hyperplasia||Procedure: transurethral resection of the prostate|
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 Type :||Observational|
|Estimated Enrollment :||50 participants|
|Official Title:||Bipolar Transurethral Resection of the Prostate; Complications and Possibility to do as Outpatient Procedure|
|Estimated Study Start Date :||May 15, 2019|
|Estimated Primary Completion Date :||February 15, 2020|
|Estimated Study Completion Date :||September 30, 2020|
- Procedure: transurethral resection of the prostate
Surgical removal of benign prostatic tissueOther Name: TUR P
- Proportion of patients able to be discharged the day of surgery [ Time Frame: One day ]
- Proportion of patients readmitted to hospital the first day of surgery [ Time Frame: One day ]
- Change in IPSS score [ Time Frame: 6 months ]International prostate symptom score, range 0-35
- Number of patients with cancer in surgical specimen [ Time Frame: 6 months ]Pathological confirmed prostate cancer, all Gleasson Grades (6-10)
- Readmission rates within 30 days of surgery [ Time Frame: 30 days ]
- Complications [ Time Frame: 30 days ]Clavien Dindo Classification
- Proportion catheter free [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03959917
|Östersund, Jämtland, Sweden, 83133|
|Contact: Karl-Johan Lundström, M.D, Ph.D 004663153000 firstname.lastname@example.org|
|Contact: Karl-Johan Lundström email@example.com|
|Sub-Investigator: Simon Bygdell, M.D|