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PI retired and no recruitment occurred
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"Fast-track" or "enhanced recovery" programs, which are the new standardized accelerated clinical pathways for post-operative care for colorectal surgeries, have three goals: to 1) quicken the return of bowel function (as evidenced by passage of flatus and stool), 2) decrease the length of hospital stays, and 3) decrease the rate of overall complications. Aside from several components, or interventions that can vary from institution to institution, these programs share three common modalities: early oral feeding, protocol pain management regimens less dependent on opioid use, and early mobilization (i.e. ambulation). Evidence-based practice has shown that the modalities individually contribute significantly to the program goals except for post-operative ambulation, which has not been shown to increase bowel function although it contributes to decreased pulmonary complications and early discharge of patients. Still, surgeons continue to advocate for early ambulation to aid in the return of bowel function despite the lack of clear evidence supporting this notion.
The investigators propose a randomized, prospective clinical trial exploring the impact that post-operative ambulation has on the outcome of colorectal surgeries, particularly on the return of bowel function and the length of hospital stay. With the use of pedometers to measure physical activity, the investigators will subject patients to either the current traditional post-operative care or one with an aggressive ambulation regimen. Through the use of radiopaque markers, the investigators hope to correlate increased ambulation with increased gastrointestinal motility function to prove the impact of early ambulation on post-operative care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Traditional Ambulation regimen | Placebo Comparator | All patients will receive pedometers to record the total amount of ambulation. These patients will ambulate without limitations or goals. Most surgeons request that post-operative patients ambulate at least 2 to 3 times a day. |
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| Walkers | Active Comparator | All patients will receive pedometers to record the total amount of ambulation. Patients in the experimental group will have assigned nursing staff assisting in ambulation in these patients at least three times a day. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ambulation regimen | Procedure | Assistance and encouragement for at least ambulation 3 times a day |
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| Measure | Description | Time Frame |
|---|---|---|
| Return of bowel function | To demonstrate that increased ambulation as an independent post-operative variable leads to a quicker return of bowel function | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Shorter Length of hospitalization | To demonstrate that increased ambulation as an independent post-operative variable leads to a shorter length of hospitalization | 1 week |
| Post-operative complications |
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Inclusion Criteria:
Subject patients are those who will undergo colorectal surgeries at NMCP. Colorectal surgery is defined as any surgery involving the gastrointestinal tract from the ileocecal valve to the dentate line and includes all laparoscopic approaches. This surgery includes, but is not limited to:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ellie Mentler, MD | United States Naval Medical Center, Portsmouth | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Naval Medical Center Portsmouth | Portsmouth | Virginia | 23708 | United States |
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| Sitz-Markers | Drug | radiopaque markers to subjectively follow the return of bowel function |
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| Daily abdominal x-rays | Radiation | daily abdominal x-rays for 7 days - to follow the radiopaque markers |
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| pedometers | Device | to record the amount of ambulation |
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To demonstrate that increased ambulation as an independent post-operative variable leads to a decrease in the number of overall complications as recorded over a 30-day period post-operatively
| 30 days |
| Return of normal activities | To demonstrate that increased ambulation as an independent post-operative variable leads to a quicker return of normal activities within a 30-day post-operative period. | 30 days |