Stoma Tube Decompression and Postoperative Ileus After Major Colorectal Surgery

This study has been terminated.
(Not enough staff resource to complete study.)
Sponsor:
Information provided by (Responsible Party):
Phillip Fleshner MD, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier:
NCT01911793
First received: July 26, 2013
Last updated: July 21, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Ileus
Bowel Obstruction
Device: Stoma Tube

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Stoma Tube Decompression and Postoperative Ileus After Major Colorectal Surgery

Resource links provided by NLM:


Further study details as provided by Cedars-Sinai Medical Center:

Primary Outcome Measures:
  • Tolerating low residue diet [ Time Frame: by postoperative day 3( 3rd day after surgery) ] [ Designated as safety issue: No ]
    % of patients tolerating a low residue diet on postoperative day 3 will be assessed


Secondary Outcome Measures:
  • Time to flatus (passing gas into stoma bag) [ Time Frame: during 30 day postoperative period ] [ Designated as safety issue: No ]
    # of hours after surgery at which point first passage of flatus (gas) into stoma bag

  • time to passage of stool [ Time Frame: during 30 day postoperative period ] [ Designated as safety issue: No ]
    # of hours after surgery until the patient passes stool into stoma bag

  • hospital discharge [ Time Frame: 30 day postoperative period ] [ Designated as safety issue: No ]
    postoperative day after surgery which patient was discharged home

  • time to discharge based on GI function [ Time Frame: 30 day postoperative period ] [ Designated as safety issue: No ]
    postoperative day which patient is considered ready for discharge based solely on Gastrointestinal function

  • major and minor medical and surgical complications [ Time Frame: 30 day postoperative period ] [ Designated as safety issue: Yes ]
    any major or minor medical and surgical complications after surgery will be recorded

  • any insertion of nasogastric tube [ Time Frame: 30 day postoperative period ] [ Designated as safety issue: No ]
    insertion of nasogastric tube after surgery will be recorded

  • episodes of vomiting [ Time Frame: during postoperative hospital admission (30 day period) ] [ Designated as safety issue: No ]
    any episodes of vomiting will be recorded

  • diagnosis of postoperative ileus [ Time Frame: 30 day postoperative period ] [ Designated as safety issue: No ]
    diagnosis of postoperative ileus or bowel obstruction made by attending surgeon based on clinical data including abdominal distention, nausea/vomiting, decreased stom output and radiologic factors


Enrollment: 6
Study Start Date: July 2013
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stoma tube
Stoma tube (18 French) red robinson catheter inserted into stoma at the time of surgery
Device: Stoma Tube
Stoma tube will be inserted into stoma at the time of surgery for patients assigned to Stoma Tube group.
Other Name: Red robinson catheter
No Intervention: Standard Stoma
Patients will have standard stoma created without insertion of stoma tube. Stoma tube will only be inserted postopertively if the patient is felt to have postopeprative ileus, nausea, vomiting, and decreased stoma output as per standard protocol.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Able to freely give written informed consent to participate in the study and have signed the Informed Consent Form;
  2. Males or females, 18> years of age and older inclusive at the time of study screening;
  3. American Society of Anesthesiologists (ASA) Class I-III (Appendix III);
  4. Due to undergo ileostomy or colostomy creation via laparotomy or laparoscopy;

Exclusion Criteria:

  1. Mentally incompetent or unable or unwilling to provide informed consent or comply with study procedures;
  2. American Society of Anesthesiologists (ASA) Class IV or V;
  3. Children <18 years
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01911793

Locations
United States, California
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
Sponsors and Collaborators
Cedars-Sinai Medical Center
Investigators
Principal Investigator: Phillip Fleshner, MD Cedars-Sinai Medical Center
  More Information

Publications:
Responsible Party: Phillip Fleshner MD, Director of Colorectal Surgery Residency, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT01911793     History of Changes
Other Study ID Numbers: Stoma Tube Study
Study First Received: July 26, 2013
Last Updated: July 21, 2014
Health Authority: USA: Cedars Sinai Institutional Review Board

Keywords provided by Cedars-Sinai Medical Center:
stoma
ileus
postoperative
stoma tube

Additional relevant MeSH terms:
Intestinal Obstruction
Ileus
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on July 23, 2014