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

NCT01241123 | Withdrawn DMC

• 1 other identifier: CIP# 10-0061
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Keywords

return of bowel function, post-operative, colon surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Shorter Length of hospitalization

  1 week

• Post-operative complications

  30 days

• Return of normal activities

  30 days

Study Arms (2)

Traditional Ambulation regimen

PLACEBO COMPARATOR

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; Radiation: Daily abdominal x-rays; Device: pedometers

Walkers

ACTIVE COMPARATOR

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; Drug: Sitz-Markers; Radiation: Daily abdominal x-rays; Device: pedometers

Interventions

Ambulation regimen PROCEDURE

Assistance and encouragement for at least ambulation 3 times a day

Walkers

Sitz-Markers DRUG

radiopaque markers to subjectively follow the return of bowel function

Traditional Ambulation regimen; Walkers

Daily abdominal x-rays RADIATION

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

Traditional Ambulation regimen; Walkers

pedometers DEVICE

to record the amount of ambulation

Traditional Ambulation regimen; Walkers

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• United States Naval Medical Center, Portsmouth: lead

Study Sites (1)

Naval Medical Center Portsmouth

Portsmouth, Virginia, 23708, United States

Location

Study Officials

• Ellie Mentler, MD

  United States Naval Medical Center, Portsmouth

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2010
• First Posted: November 16, 2010
• Study Start: March 31, 2010
• Primary Completion: September 10, 2014
• Study Completion: September 10, 2014
• Last Updated: July 29, 2025

Record last verified: 2025-07

Locations

US (1)