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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by United States Naval Medical Center, Portsmouth.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
United States Naval Medical Center, Portsmouth
ClinicalTrials.gov Identifier:
NCT01241123
First received: November 15, 2010
Last updated: NA
Last verified: November 2010
History: No changes posted

November 15, 2010
November 15, 2010
November 2010
December 2012   (final data collection date for primary outcome measure)
Return of bowel function [ Time Frame: 1 week ] [ Designated as safety issue: No ]
To demonstrate that increased ambulation as an independent post-operative variable leads to a quicker return of bowel function
Same as current
No Changes Posted
  • Shorter Length of hospitalization [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    To demonstrate that increased ambulation as an independent post-operative variable leads to a shorter length of hospitalization
  • Post-operative complications [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    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
  • Return of normal activities [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    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.
Same as current
Not Provided
Not Provided
 
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

"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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Return of Bowel Function After Colon Surgery
  • 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
  • Placebo Comparator: Traditional Ambulation regimen
    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.
    Interventions:
    • Drug: Sitz-Markers
    • Radiation: Daily abdominal x-rays
    • Device: pedometers
  • Active Comparator: Walkers
    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.
    Interventions:
    • Procedure: Ambulation regimen
    • Drug: Sitz-Markers
    • Radiation: Daily abdominal x-rays
    • Device: pedometers
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
98
Not Provided
December 2012   (final data collection date for primary outcome measure)

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.
Both
17 Years and older
No
Contact: Ellie Mentler, MD 757-953-2454 ellie.mentler@med.navy.mil
Contact: Charles Morgan, PhD 757-953-5939 charles.morgan@med.navy.mil
United States
 
NCT01241123
CIP# 10-0061
Yes
LT Ellie Mentler, Naval Medical Centerl Porsmouth
United States Naval Medical Center, Portsmouth
Not Provided
Principal Investigator: Ellie Mentler, MD United States Naval Medical Center, Portsmouth
United States Naval Medical Center, Portsmouth
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP