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

NCT01241123 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2025-07-29

No results posted yet for this study

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

  • Return of Bowel Function After Colon Surgery

Interventions

PROCEDURE

Ambulation regimen

Assistance and encouragement for at least ambulation 3 times a day

DRUG

Sitz-Markers

radiopaque markers to subjectively follow the return of bowel function

RADIATION

Daily abdominal x-rays

daily abdominal x-rays for 7 days - to follow the radiopaque markers

DEVICE

pedometers

to record the amount of ambulation

Sponsors & Collaborators

  • United States Naval Medical Center, Portsmouth

    lead FED

Principal Investigators

  • Ellie Mentler, MD · United States Naval Medical Center, Portsmouth

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2014-09-10
Completion
2014-09-10

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01241123 on ClinicalTrials.gov