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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
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Benign Prostatic Hyperplasia Procedure: transurethral resection of the prostate

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.


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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Intervention Details:
  • Procedure: transurethral resection of the prostate
    Surgical removal of benign prostatic tissue
    Other Name: TUR P


Primary Outcome Measures :
  1. Proportion of patients able to be discharged the day of surgery [ Time Frame: One day ]
  2. Proportion of patients readmitted to hospital the first day of surgery [ Time Frame: One day ]

Secondary Outcome Measures :
  1. Change in IPSS score [ Time Frame: 6 months ]
    International prostate symptom score, range 0-35

  2. Number of patients with cancer in surgical specimen [ Time Frame: 6 months ]
    Pathological confirmed prostate cancer, all Gleasson Grades (6-10)

  3. Readmission rates within 30 days of surgery [ Time Frame: 30 days ]
  4. Complications [ Time Frame: 30 days ]
    Clavien Dindo Classification

  5. Proportion catheter free [ Time Frame: 6 months ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This is a feasibility cohort study. All patients planned for TUR P are eligible. Patients in the ambulatory group have prostate size less than 50 cc and ASA score less less than 4 and ser under 80 years of age. This is clinical routine at the study site.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • No consent to participate

Information from the National Library of Medicine

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


Locations
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Sweden
Östersunds hospital Recruiting
Östersund, Jämtland, Sweden, 83133
Contact: Karl-Johan Lundström, M.D, Ph.D    004663153000    karl-johan.lundstrom@regionjh.se   
Contact: Karl-Johan Lundström       karl_johan@hotmail.com   
Sub-Investigator: Simon Bygdell, M.D         
Sponsors and Collaborators
Umeå University

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Responsible Party: Umeå University
ClinicalTrials.gov Identifier: NCT03959917     History of Changes
Other Study ID Numbers: EPN 201801-12
First Posted: May 22, 2019    Key Record Dates
Last Update Posted: May 24, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Umeå University:
prostate
resection
incontinence
erectile dysfunction

Additional relevant MeSH terms:
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Hyperplasia
Prostatic Hyperplasia
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male