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Stoma Tube Decompression and Postoperative Ileus After Major Colorectal Surgery

NCT01911793 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2018-03-07

Study results available
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Summary

Postoperative ileus is common after colorectal surgery, occurring in up to 20% of patients. Stomas are frequently created in conjunction with major colorectal surgery. Obstruction at the level of the stoma is a common cause of bowel obstruction or ileus. This is often manifested by decrease or delay in stoma output and is often attributed to edema at the level of the stoma. Thus, a temporary tube (red robinson catheter) is placed into the stoma at bedside, which often relieves the obstruction until the edema at the level of the stoma resolves and stoma function occurs around the temporary tube. At this time, the tube is removed and the stoma continues to function normally.

The purpose of this study is to evaluate whether a stoma tube (red-robinson catheter) placed at the time of stoma creation would reduce the incidence of postoperative ileus in patients undergoing major colorectal surgery with creation of a stoma.

Conditions

  • Ileus
  • Bowel Obstruction

Interventions

DEVICE

Stoma Tube

Stoma tube will be inserted into stoma at the time of surgery for patients assigned to Stoma Tube group.

Sponsors & Collaborators

  • Cedars-Sinai Medical Center

    lead OTHER

Principal Investigators

  • Phillip Fleshner, MD · Cedars-Sinai Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2014-07-31
Completion
2014-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01911793 on ClinicalTrials.gov