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Patients no longer staying overnight in the hospital following this procedure type.
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To determine the effect of post-operative abdominal binder usage on total narcotic usage after undergoing surgery. To determine if abdominal binder usage results in decreased visual analog scale (VAS) pain scores and shorter time to first ambulation post operatively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control / No Binder | No Intervention | Patients randomized to routine care / no abdominal binder use will not use an abdominal binder during their post operative course. | |
| Abdominal binder | Experimental | Patients randomized abdominal binder use will have an abdominal binder placed on them in the operating room once their surgery has been completed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abdominal binder | Device | The abdominal binder is an elastic abdominal compression / support device that will be placed on the patient after surgery has been completed. |
|
| Measure | Description | Time Frame |
|---|---|---|
| To Assess Effect of Abdominal Binder on Total Post-operative Narcotic Use Within Seven Days Following Pelvic Surgery | Total narcotic usage, calculated in morphine equivalents, during the first seven days post operatively to be calculated and a difference in the amount used by non-abdominal binder patients and abdominal binder patients will be determined. Will review medical record to determine amount of medication used while inpatient, amount / type of narcotic medication prescribed for discharge home, and will call patients to determine how many narcotic pills they have remaining on post operative day seven and calculate the amount used which will then be converted to morphine equivalents. | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| To Assess Whether Post Operative Abdominal Binder Usage Shortens the Time to First Ambulation After Surgery. | Difference in the first time of ambulation after surgery during inpatient admission between non-abdominal binder patients and abdominal binder patients. | 1 day |
| To Compare Post Operative Pain Scores Using Visual Analog Scale (VAS) Scores in Post Operatives Patients Who Use and do Not Use an Abdominal Binder. |
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Inclusion Criteria:
Exclusion Criteria:
Based on female biological sex due to requirement of pelvic surgery.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals | Cleveland | Ohio | 44106 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control / No Binder | Patients randomized to routine care / no abdominal binder use will not use an abdominal binder during their post operative course. |
| FG001 | Abdominal Binder |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Aug 24, 2020 |
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Difference in VAS pain scores will be obtained only while the patient is admitted to the hospital post operatively between non-abdominal binder patients and abdominal binder patients. |
| 1 day |
Patients randomized abdominal binder use will have an abdominal binder placed on them in the operating room once their surgery has been completed.
Abdominal binder: The abdominal binder is an elastic abdominal compression / support device that will be placed on the patient after surgery has been completed.
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Control / No Binder | Patients randomized to routine care / no abdominal binder use will not use an abdominal binder during their post operative course. |
| BG001 | Abdominal Binder | Patients randomized abdominal binder use will have an abdominal binder placed on them in the operating room once their surgery has been completed. Abdominal binder: The abdominal binder is an elastic abdominal compression / support device that will be placed on the patient after surgery has been completed. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
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| 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 | To Assess Effect of Abdominal Binder on Total Post-operative Narcotic Use Within Seven Days Following Pelvic Surgery | Total narcotic usage, calculated in morphine equivalents, during the first seven days post operatively to be calculated and a difference in the amount used by non-abdominal binder patients and abdominal binder patients will be determined. Will review medical record to determine amount of medication used while inpatient, amount / type of narcotic medication prescribed for discharge home, and will call patients to determine how many narcotic pills they have remaining on post operative day seven and calculate the amount used which will then be converted to morphine equivalents. | Data not collected | Posted | 7 days |
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| ||||||||||||||||||||||
| Secondary | To Assess Whether Post Operative Abdominal Binder Usage Shortens the Time to First Ambulation After Surgery. | Difference in the first time of ambulation after surgery during inpatient admission between non-abdominal binder patients and abdominal binder patients. | Data not collected | Posted | 1 day |
|
| ||||||||||||||||||||||
| Secondary | To Compare Post Operative Pain Scores Using Visual Analog Scale (VAS) Scores in Post Operatives Patients Who Use and do Not Use an Abdominal Binder. | Difference in VAS pain scores will be obtained only while the patient is admitted to the hospital post operatively between non-abdominal binder patients and abdominal binder patients. | Data not collected | Posted | 1 day |
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Death, serious adverse events, and other were not assessed for this study
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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 | Control / No Binder | Patients randomized to routine care / no abdominal binder use will not use an abdominal binder during their post operative course. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG001 | Abdominal Binder | Patients randomized abdominal binder use will have an abdominal binder placed on them in the operating room once their surgery has been completed. Abdominal binder: The abdominal binder is an elastic abdominal compression / support device that will be placed on the patient after surgery has been completed. | 0 | 0 | 0 | 0 | 0 | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| University Hospitals | University Hospitals | 216-844-1000 | info@uhhospitals.org |
| Apr 13, 2022 |
| Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D056887 | Pelvic Organ Prolapse |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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