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
  Purpose

"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.


Condition Intervention
Return of Bowel Function After Colon Surgery
Procedure: Ambulation regimen
Drug: Sitz-Markers
Radiation: Daily abdominal x-rays
Device: pedometers

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: The Influence of Ambulation on the Return of Bowel Function After Colorectal Surgery: Traditional Care Versus Early Mobilization Protocol

Resource links provided by NLM:


Further study details as provided by United States Naval Medical Center, Portsmouth:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 98
Study Start Date: November 2010
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
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.
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

  Eligibility

Ages Eligible for Study:   17 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01241123

Contacts
Contact: Ellie Mentler, MD 757-953-2454 ellie.mentler@med.navy.mil
Contact: Charles Morgan, PhD 757-953-5939 charles.morgan@med.navy.mil

Locations
United States, Virginia
Naval Medical Center Portsmouth Recruiting
Portsmouth, Virginia, United States, 23708
Contact: Ellie Mentler, MD    757-953-2454    ellie.mentler@med.navy.mil   
Contact: Charles Morgan, PhD    757-953-5939    charles.morgan@med.navy.mil   
Principal Investigator: Ellie Mentler, MD         
Sub-Investigator: Cade Cinnamond, DO         
Sub-Investigator: Ralph Butler, MD         
Sub-Investigator: Christian Corwin, MD         
Sub-Investigator: Beth Jaklic, MD         
Sub-Investigator: Paul Lucha, DO         
Sponsors and Collaborators
United States Naval Medical Center, Portsmouth
Investigators
Principal Investigator: Ellie Mentler, MD United States Naval Medical Center, Portsmouth
  More Information

No publications provided

Responsible Party: LT Ellie Mentler, Naval Medical Centerl Porsmouth
ClinicalTrials.gov Identifier: NCT01241123     History of Changes
Other Study ID Numbers: CIP# 10-0061
Study First Received: November 15, 2010
Last Updated: November 15, 2010
Health Authority: United States: Federal Government

Keywords provided by United States Naval Medical Center, Portsmouth:
return of bowel function, post-operative, colon surgery

ClinicalTrials.gov processed this record on September 18, 2014