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

NCT ID: NCT01241123

Last Updated: 2025-07-29

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2014-09-10

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: PLACEBO_COMPARATOR

Sitz-Markers

Intervention Type: DRUG

radiopaque markers to subjectively follow the return of bowel function

Daily abdominal x-rays

Intervention Type: RADIATION

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

pedometers

Intervention Type: DEVICE

to record the amount of ambulation

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.

Group Type: ACTIVE_COMPARATOR

Ambulation regimen

Intervention Type: PROCEDURE

Assistance and encouragement for at least ambulation 3 times a day

Sitz-Markers

Intervention Type: DRUG

radiopaque markers to subjectively follow the return of bowel function

Daily abdominal x-rays

Intervention Type: RADIATION

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

pedometers

Intervention Type: DEVICE

to record the amount of ambulation

Interventions

Ambulation regimen

Assistance and encouragement for at least ambulation 3 times a day

Intervention Type: PROCEDURE

Sitz-Markers

radiopaque markers to subjectively follow the return of bowel function

Intervention Type: DRUG

Daily abdominal x-rays

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

Intervention Type: RADIATION

pedometers

to record the amount of ambulation

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

United States Naval Medical Center, Portsmouth

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ellie Mentler, MD

Role: PRINCIPAL_INVESTIGATOR

United States Naval Medical Center, Portsmouth

Locations

Naval Medical Center Portsmouth

Portsmouth, Virginia, United States

Countries

United States

Other Identifiers

CIP# 10-0061

Identifier Type: -

Identifier Source: org_study_id