Clinical Trials Directory

Trials / Withdrawn

WithdrawnNCT01241123

The Influence of Ambulation on the Return of Bowel Function After Colorectal Surgery

The Influence of Ambulation on the Return of Bowel Function After Colorectal Surgery: Traditional Care Versus Early Mobilization Protocol

Status
Withdrawn
Phase
N/A
Study type
Interventional
Enrollment
0 (actual)
Sponsor
United States Naval Medical Center, Portsmouth · Federal
Sex
All
Age
17 Years
Healthy volunteers
Not accepted

Summary

"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.

Conditions

Interventions

TypeNameDescription
PROCEDUREAmbulation regimenAssistance and encouragement for at least ambulation 3 times a day
DRUGSitz-Markersradiopaque markers to subjectively follow the return of bowel function
RADIATIONDaily abdominal x-raysdaily abdominal x-rays for 7 days - to follow the radiopaque markers
DEVICEpedometersto record the amount of ambulation

Timeline

Start date
2010-03-31
Primary completion
2014-09-10
Completion
2014-09-10
First posted
2010-11-16
Last updated
2025-07-29

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01241123. Inclusion in this directory is not an endorsement.