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TURP; Complications and Outpatient Care

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date May 21, 2019
First Posted Date May 22, 2019
Last Update Posted Date May 24, 2019
Estimated Study Start Date May 15, 2019
Estimated Primary Completion Date February 15, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 21, 2019)
  • 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 ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03959917 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: May 23, 2019)
  • 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 ]
Original Secondary Outcome Measures
 (submitted: May 21, 2019)
  • IPSS [ Time Frame: 6 months ]
    Internation prostate symptom score
  • Cancer in surgical specimen [ Time Frame: 6 months ]
  • Readmissions within 30 days of surgery [ Time Frame: 30 days ]
  • Complications [ Time Frame: 30 days ]
    Clavien Dindo Classification
  • Proportion catheter free [ Time Frame: 6 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title TURP; Complications and Outpatient Care
Official Title Bipolar Transurethral Resection of the Prostate; Complications and Possibility to do as Outpatient Procedure
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Benign Prostatic Hyperplasia
Intervention Procedure: transurethral resection of the prostate
Surgical removal of benign prostatic tissue
Other Name: TUR P
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 21, 2019)
50
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 30, 2020
Estimated Primary Completion Date February 15, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • No consent to participate
Sex/Gender
Sexes Eligible for Study: Male
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Listed Location Countries Sweden
Removed Location Countries  
 
Administrative Information
NCT Number NCT03959917
Other Study ID Numbers EPN 201801-12
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Umeå University
Study Sponsor Umeå University
Collaborators Not Provided
Investigators Not Provided
PRS Account Umeå University
Verification Date May 2019