Transforaminal Lumbar Interbody Fusion
Conditions
Brief summary
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).
Detailed description
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.
Interventions
DEVICEFoley Catheter
The patient is catheterized during surgery.
Sponsors
Rush University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* Patients undergoing a primary single-level MIS TLIF (Diagnosis: radiculopathy, stenosis, herniated nucleus pulposus, degenerative disc disease, spondylosis, osteophytic complexes, spondylolysis, spondylolisthesis) * Patients able to provide informed consent
Exclusion criteria
* Patients with baseline urinary dysfunction requiring manual bladder emptying via intermittent straight catheterization, suprapubic catheters, or other indwelling catheters. -Allergies or other contraindications to medicines in the post- operative urinary retention protocol * Lack of consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Length of Hospital Stay | Date of surgery until the date of hospital discharge, up to 1 month | How long was the patients post-operative stay? |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Indwelling Foley Indwelling Foley placed during surgery
Foley Catheter: The patient is catheterized during surgery. | 3 |
| 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. | 2 |
| No Catheter Patient is not catheterized | 2 |
| Total | 7 |
Baseline characteristics
| Characteristic | Straight Catheter | No Catheter | Indwelling Foley | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 1 Participants | 2 Participants | 5 Participants |
| Age, Continuous | 57 years | 58 years | 55 years | 57 years |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants |
| Region of Enrollment United States | 2 participants | 2 participants | 3 participants | 7 participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 2 Participants | 4 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 1 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 2 | 0 / 2 |
| other Total, other adverse events | 0 / 3 | 0 / 2 | 0 / 2 |
| serious Total, serious adverse events | 0 / 3 | 0 / 2 | 0 / 2 |
Outcome results
Primary
Length of Hospital Stay
How long was the patients post-operative stay?
Time frame: Date of surgery until the date of hospital discharge, up to 1 month
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Indwelling Foley | Length of Hospital Stay | 3 days |
| Straight Catheter | Length of Hospital Stay | 2 days |
| No Catheter | Length of Hospital Stay | 2 days |