- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03959917
TURP; Complications and Outpatient Care
Bipolar Transurethral Resection of the Prostate; Complications and Possibility to do as Outpatient Procedure
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
Jämtland
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Östersund, Jämtland, Sweden, 83133
- Recruiting
- Östersunds hospital
-
Contact:
- Karl-Johan Lundström, M.D, Ph.D
- Phone Number: 004663153000
- Email: karl-johan.lundstrom@regionjh.se
-
Contact:
- Karl-Johan Lundström
- Email: karl_johan@hotmail.com
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Sub-Investigator:
- Simon Bygdell, M.D
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Planned for transurethral resection of the prostate (TUR P)
Exclusion Criteria:
- No consent to participate
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Proportion of patients able to be discharged the day of surgery
Time Frame: One day
|
One day
|
Proportion of patients readmitted to hospital the first day of surgery
Time Frame: One day
|
One day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in IPSS score
Time Frame: 6 months
|
International prostate symptom score, range 0-35
|
6 months
|
Number of patients with cancer in surgical specimen
Time Frame: 6 months
|
Pathological confirmed prostate cancer, all Gleasson Grades (6-10)
|
6 months
|
Readmission rates within 30 days of surgery
Time Frame: 30 days
|
30 days
|
|
Complications
Time Frame: 30 days
|
Clavien Dindo Classification
|
30 days
|
Proportion catheter free
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EPN 201801-12
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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