View Clinical Trial (Medical Research Study)
The Influence of Ambulation on the Return of Bowel Function After Colorectal Surgery: Traditional Care Versus Early Mobilization Protocol
| City: |
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Portsmouth |
| State: |
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Virginia |
| Zip Code: |
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23708 |
| Conditions: |
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Return of Bowel Function After Colon Surgery |
| Purpose: |
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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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| Study Summary: |
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| Criteria: |
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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:
- Ileocecetomy
- Partial colectomy (including right, left, and sigmoid colectomies)
- Hartmann procedure
- Total abdominal colectomy
- Proctocolectomy
- Colostomy formation or takedown
- Low anterior resection
- Abdominoperineal resection
Exclusion Criteria:
- Reasons for subject exclusion are non-ambulatory conditions are conditions whereby a
subject cannot walk or move from place to place. Examples of non-ambulatory
conditions include but are not limited to: severe vasculopathy with limiting
claudication (leg pain when ambulating due to poor blood flow) of less than 100
meters, all wheelchair bound conditions (anatomically missing both legs without
adequate prosthesis, severely limiting pulmonary disease, neurologic disorders -
Amyotrophic Lateral Sclerosis, severe multiple sclerosis, paraplegia), fractured leg
bones requiring temporary and/or permanent use of a walking aid or any congenital
disorders limiting ambulation (osteogenesis imperfecta, muscular dystrophy, cerebral
palsy). Any patient who takes Alvimopan (Entereg ®) will be excluded or terminated
from the study. Alvimopan is an FDA-approved drug that accelerates bowel motility
and is used to prevent and/or treat post-operative ileus. In addition, patients with
underlying gastrointestinal motility issues, gastroparesis, chronic constipation, etc
or who may have complications who may not be able to ambulate during the hospital
course (i.e. prolonged intubated postoperatively) will be excluded as well. Pregnant
women will also be excluded from the study.
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| NCT ID: |
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NCT01241123 |
| Primary Contact: |
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Principal Investigator
Ellie Mentler, MD
Naval Medical Center Portsmouth
Ellie Mentler, MD
Phone: 757-953-2454
Email: ellie.mentler@med.navy.mil
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| Backup Contact: |
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Email: charles.morgan@med.navy.mil
Charles Morgan, PhD
Phone: 757-953-5939
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| Location Contact: |
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Portsmouth, Virginia 23708
United States
Ellie Mentler, MD
Phone: 757-953-2454
Email: ellie.mentler@med.navy.mil
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 25, 2013 |
| Modifications to this listing: |
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