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PI initiated closure due to limited clinical resources and lack of participation.
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To determine if indwelling Foley placement at the onset of the procedure, straight catherization at the conclusion of the procedure, or no catheterization produces the lowest rates of postoperative urinary retention after transforaminal lumbar interbody fusions (TLIFs).
Post-operative urinary retention (POUR) is one the most common post-operative complications after elective spine surgeries. Common causes of postoperative urinary retention (POUR) include bladder stenosis, distension, trauma due to catheterizations, age, and prostate hyperplasia. The incidence of POUR increases with age, gender, types of surgery conducted, any comorbidities such as cerebral palsy or multiple sclerosis, use of drugs such as anticholinergic agents, beta blockers, or sympathomimetics, and use of IV fluids.
This condition has been associated with the development of UTIs and sepsis, increased post-operative length of stay (LOS), and 90-day readmission after surgery. In the field of spine surgery, the reported incidence of POUR is highly variable, and there is no consensus on effective methods of prevention. We set out to assess POUR from patients catheterized compared to non-catheterized following a transforaminal lumbar interbody fusion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Indwelling Foley | Experimental | Indwelling Foley placed during surgery |
|
| Straight Catheter | Active Comparator | straight catheterization (in-and-out straight catheterization) will take place at the end of the surgery |
|
| No Catheter | No Intervention | Patient is not catheterized |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Foley Catheter | Device | The patient is catheterized during surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Length of Hospital Stay | How long was the patients post-operative stay? | Date of surgery until the date of hospital discharge, up to 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Indwelling Foley | Indwelling Foley placed during surgery Foley Catheter: The patient is catheterized during surgery. |
| FG001 | Straight Catheter | straight catheterization (in-and-out straight catheterization) will take place at the end of the surgery Foley Catheter: The patient is catheterized during surgery. |
| FG002 | No Catheter | Patient is not catheterized |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Indwelling Foley | Indwelling Foley placed during surgery Foley Catheter: The patient is catheterized during surgery. |
| BG001 | Straight Catheter | straight catheterization (in-and-out straight catheterization) will take place at the end of the surgery Foley Catheter: The patient is catheterized during surgery. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Length of Hospital Stay | How long was the patients post-operative stay? | Posted | Mean | 95% Confidence Interval | days | Date of surgery until the date of hospital discharge, up to 1 month |
|
From the date of surgery to 6 months post-surgical
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Indwelling Foley | Indwelling Foley placed during surgery Foley Catheter: The patient is catheterized during surgery. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kern Singh, MD | Rush University Medical Center | (312) 432-2435 | kern.singh@rushortho.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 12, 2021 | Oct 13, 2021 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 12, 2021 | Oct 13, 2021 | ICF_002.pdf |
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| BG002 | No Catheter | Patient is not catheterized |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Patient is not catheterized |
|
|
| 0 |
| 3 |
| 0 |
| 3 |
| 0 |
| 3 |
| EG001 | Straight Catheter | straight catheterization (in-and-out straight catheterization) will take place at the end of the surgery Foley Catheter: The patient is catheterized during surgery. | 0 | 2 | 0 | 2 | 0 | 2 |
| EG002 | No Catheter | Patient is not catheterized | 0 | 2 | 0 | 2 | 0 | 2 |
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| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|