External Causes of Morbidity and Mortality
Conditions
Keywords
discharge criteria, gynecologic surgery, post-op ambulation
Brief summary
This study is a non-blinded randomized controlled trial. Consenting participants will be randomized to routine post-operative ambulation vs. goal-augmented post-operative care (they will be given a goal number of steps to take on each post-operative day) following in-patient gynecologic surgery.
Detailed description
This study is a non-blinded randomized controlled trial. Consenting participants will be randomized to routine post-operative ambulation vs. treadmill-augmented post-operative care (placement of non-motorized treadmill in their room) following in-patient gynecologic surgery. We will approach all women undergoing gynecologic procedures that are expected to ambulate within 12 hours of their operation and are anticipated to remain hospitalized at least 18 hours. Following confirmation of eligibility, we will enroll subjects either in the clinic when they are being consented for their gynecologic procedure or upon presentation to the hospital the day of their procedure. Randomization will occur at the completion of the gynecologic procedure when it has been confirmed by the primary surgeon that the patient is able to ambulate independently within 12 hours after completion of the procedure. At that time, participants will be randomized using opaque envelopes prepared by the study statistician in a 1:1 ratio to receive usual post-operative care or treadmill-augmented care. All patients will have a pedometer placed on their person in the post-anesthesia recovery unit (PACU) which will be removed the day of their discharge. The primary outcome assessed will be number of steps taken in the 24 hour period prior to discharge as assessed by the electronic pedometer readings. Pedometer will be placed on patients using a lanyard and pedometer clip in the recovery room. No participant will start ambulation without physician's clinical order. When the patient is ready for the first ambulation she will be accompanied by a nurse to sit up in a chair. Once the patient is able to ambulate herself she may ambulate in her room or in the hallway or if randomized to treadmill group she will be able to ambulate on the treadmill. She will be wearing her pedometer at all times until discharge from Loyola.
Interventions
BEHAVIORALgoal-augmented post-operative care
Patients in the goal-augmented post-operative care group will be given a goal number of steps to take on each post-operative day following in-patient gynecologic surgery.
Sponsors
Loyola University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Independent ambulation pre-operatively * Undergoing gynecologic procedure * Expected to ambulate within 12 hours of their procedure
Exclusion criteria
* Children under the age of 18 * Inability to ambulate independently prior to their surgery * Primary surgeon does not want patient to ambulate within 12 hours of procedure * English is not the primary language spoken by the patient
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Steps Taken in 24 Hours. | 1 day | The primary outcome assessed was the number of steps taken in the 24 hour period prior to discharge as assessed by the electronic pedometer readings. |
Countries
United States
Participant flow
Recruitment details
This randomized controlled trial enrolled patients who were going to undergo gynecologic surgery were enrolled from 1/11-6/11 at Loyola University Medical Center .We approached adult (\>18 years) English speaking women prior to undergoing major gynecologic surgery who were expected to have at least a 24-hour hospital stay post-operatively.
Pre-assignment details
All Enrolled patients were randomized to a group. Those patients who were enrolled but not included in statistical analysis had their data lost due to lost pedometer.
Participants by arm
| Arm | Count |
|---|---|
| Goal-augmented Post-operative Care. Patients in this group will be given a goal number of steps to take on each post-operative day. | 69 |
| Usual Care routine post-operative ambulation | 77 |
| Total | 146 |
Baseline characteristics
| Characteristic | Usual Care | Goal-augmented Post-operative Care. | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 16 Participants | 16 Participants | 32 Participants |
| Age, Categorical Between 18 and 65 years | 61 Participants | 53 Participants | 114 Participants |
| Age, Continuous | 53.9 years STANDARD_DEVIATION 13.27 | 56.1 years STANDARD_DEVIATION 11.1 | 54.98 years STANDARD_DEVIATION 12.3 |
| Region of Enrollment United States | 77 participants | 69 participants | 146 participants |
| Sex: Female, Male Female | 77 Participants | 69 Participants | 146 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 69 | 0 / 77 |
| serious Total, serious adverse events | 0 / 69 | 0 / 77 |
Outcome results
Primary
Number of Steps Taken in 24 Hours.
The primary outcome assessed was the number of steps taken in the 24 hour period prior to discharge as assessed by the electronic pedometer readings.
Time frame: 1 day
Population: The analysis is an intention to treat (ITT) analysis comprising all participants who were randomized.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Goal-augmented Post-operative Care. | Number of Steps Taken in 24 Hours. | 80 Steps |
| Usual Care | Number of Steps Taken in 24 Hours. | 87 Steps |
p-value: 0.7Wilcoxon (Mann-Whitney)