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.

Study Overview

• Status: Withdrawn
• Conditions: Return of Bowel Function After Colon Surgery
• Intervention / Treatment: Drug: Sitz-Markers; Radiation: Daily abdominal x-rays; Device: pedometers; Procedure: Ambulation regimen

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Portsmouth, Virginia, United States, 23708
      • Naval Medical Center Portsmouth

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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; Procedure: Ambulation regimen; Assistance and encouragement for at least ambulation 3 times a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Return of bowel function	To demonstrate that increased ambulation as an independent post-operative variable leads to a quicker return of bowel function	1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Shorter Length of hospitalization	To demonstrate that increased ambulation as an independent post-operative variable leads to a shorter length of hospitalization	1 week
Post-operative complications	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	30 days
Return of normal activities	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.	30 days

Collaborators and Investigators

• Sponsor: United States Naval Medical Center, Portsmouth
• Investigators: Principal Investigator: Ellie Mentler, MD, United States Naval Medical Center, Portsmouth

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2010
• Primary Completion (Actual): September 10, 2014
• Study Completion (Actual): September 10, 2014

Study Registration Dates

• First Submitted: November 15, 2010
• First Submitted That Met QC Criteria: November 15, 2010
• First Posted (Estimated): November 16, 2010

Study Record Updates

• Last Update Posted (Actual): July 29, 2025
• Last Update Submitted That Met QC Criteria: July 24, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: return of bowel function, post-operative, colon surgery
• Other Study ID Numbers: CIP# 10-0061