Trial Outcomes & Findings for The Effect of Abdominal Binder Use on Postoperative Pain and Mobility in Patients Undergoing Pelvic Surgery (NCT NCT03684304)
NCT ID: NCT03684304
Last Updated: 2022-05-11
Results Overview
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.
TERMINATED
NA
36 participants
7 days
2022-05-11
Participant Flow
Participant milestones
| Measure |
Control / No Binder
Patients randomized to routine care / no abdominal binder use will not use an abdominal binder during their post operative course.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
17
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
19
|
17
|
Reasons for withdrawal
| Measure |
Control / No Binder
Patients randomized to routine care / no abdominal binder use will not use an abdominal binder during their post operative course.
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
19
|
17
|
Baseline Characteristics
The Effect of Abdominal Binder Use on Postoperative Pain and Mobility in Patients Undergoing Pelvic Surgery
Baseline characteristics by cohort
| Measure |
Control / No Binder
n=19 Participants
Patients randomized to routine care / no abdominal binder use will not use an abdominal binder during their post operative course.
|
Abdominal Binder
n=17 Participants
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.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51 years
n=5 Participants
|
51 years
n=7 Participants
|
51 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
19 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
19 participants
n=5 Participants
|
17 participants
n=7 Participants
|
36 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 7 daysPopulation: Data not collected
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 dayPopulation: Data not collected
Difference in the first time of ambulation after surgery during inpatient admission between non-abdominal binder patients and abdominal binder patients.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 dayPopulation: Data not collected
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.
Outcome measures
Outcome data not reported
Adverse Events
Control / No Binder
Abdominal Binder
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place