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

Last updated: May 7, 2024
Sponsor: United States Naval Medical Center, Portsmouth
Overall Status: Terminated

Phase

N/A

Condition

N/A

Treatment

Daily abdominal x-rays

Ambulation regimen

pedometers

Clinical Study ID

NCT01241123
CIP# 10-0061
  • Ages > 17
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subject patients are those who will undergo colorectal surgeries at NMCP. Colorectalsurgery is defined as any surgery involving the gastrointestinal tract from theileocecal valve to the dentate line and includes all laparoscopic approaches. Thissurgery 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

Exclusion Criteria:

  • Reasons for subject exclusion are non-ambulatory conditions are conditions whereby asubject cannot walk or move from place to place. Examples of non-ambulatory conditionsinclude but are not limited to: severe vasculopathy with limiting claudication (legpain when ambulating due to poor blood flow) of less than 100 meters, all wheelchairbound conditions (anatomically missing both legs without adequate prosthesis, severelylimiting pulmonary disease, neurologic disorders - Amyotrophic Lateral Sclerosis,severe multiple sclerosis, paraplegia), fractured leg bones requiring temporary and/orpermanent use of a walking aid or any congenital disorders limiting ambulation (osteogenesis imperfecta, muscular dystrophy, cerebral palsy). Any patient who takesAlvimopan (Entereg ®) will be excluded or terminated from the study. Alvimopan is anFDA-approved drug that accelerates bowel motility and is used to prevent and/or treatpost-operative ileus. In addition, patients with underlying gastrointestinal motilityissues, gastroparesis, chronic constipation, etc or who may have complications who maynot be able to ambulate during the hospital course (i.e. prolonged intubatedpostoperatively) will be excluded as well. Pregnant women will also be excluded fromthe study.

Study Design

Total Participants: 30
Treatment Group(s): 4
Primary Treatment: Daily abdominal x-rays
Phase:
Study Start date:
March 31, 2010
Estimated Completion Date:
September 10, 2014

Connect with a study center

  • Naval Medical Center Portsmouth

    Portsmouth, Virginia 23708
    United States

    Site Not Available

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