An interventional study of goal-augmented post-operative care in External Causes of Morbidity and Mortality, sponsored by Loyola University. Completed at 2 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-07-08.
Sponsored by Loyola University · Not applicable, Interventional, and Prevention
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.
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.
Loyola University is the lead sponsor of 134 studies on the registry; 15 are open to participants now.
Of its 26 completed or terminated interventional studies of FDA-regulated products, 23 (88%) have results posted.
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Patients in this group will be given a goal number of steps to take on each post-operative day.
Behavioral: goal-augmented post-operative care
routine post-operative ambulation
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.
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
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.
| Milestone | Goal-augmented Post-operative Care. | Usual Care |
|---|---|---|
| Started | 69 | 77 |
| Completed | 61 | 68 |
| Not completed | 8 | 9 |
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.
| Steps | Goal-augmented Post-operative Care. | Usual Care |
|---|---|---|
| Number of Steps Taken in 24 Hours. | 80 (0 to 2353) | 87 (0 to 3576) |
Collected over During Hospitalization.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Goal-augmented Post-operative Care. | — | 0/69 (0%) | 0/69 (0%) |
| Usual Care | — | 0/77 (0%) | 0/77 (0%) |
| Age, Categorical(Participants) | Goal-augmented Post-operative Care. | Usual Care | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 53 | 61 | 114 |
| >=65 years | 16 | 16 | 32 |
| Age, Continuous(years) | Goal-augmented Post-operative Care. | Usual Care | Total |
|---|---|---|---|
| Mean | 56.1 ± 11.1 | 53.9 ± 13.27 | 54.98 ± 12.3 |
| Sex: Female, Male(Participants) | Goal-augmented Post-operative Care. | Usual Care | Total |
|---|---|---|---|
| Female | 69 | 77 | 146 |
| Male | 0 | 0 | 0 |
| Region of Enrollment(participants) | Goal-augmented Post-operative Care. | Usual Care | Total |
|---|---|---|---|
| United States | 69 | 77 | 146 |
The record gives a start of Oct 2010, a primary completion of Jun 2011 and a completion of Jun 2011. It does not say whether these dates are actual or estimated.
Results were first posted in Jul 2015, 4 years 1 month after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.
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