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TURP; Complications and Outpatient Care
| 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 |
| 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 |
- 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 ]
| 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 |
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| Original Primary Outcome Measures | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures |
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| Original Secondary Outcome Measures |
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| 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. |
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| Study Type | Observational | ||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| 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
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| 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. |
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| Recruitment Information | |||||
| Recruitment Status | Unknown status | ||||
| Estimated Enrollment |
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:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | Child, Adult, Older Adult | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| 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 |
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| 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 | ||||
