Stoma Tube Decompression and Postoperative Ileus After Major Colorectal Surgery
Primary Purpose
Ileus, Bowel Obstruction
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stoma Tube
Sponsored by
About this trial
This is an interventional prevention trial for Ileus focused on measuring stoma, ileus, postoperative, stoma tube
Eligibility Criteria
Inclusion Criteria:
- Able to freely give written informed consent to participate in the study and have signed the Informed Consent Form;
- Males or females, 18> years of age and older inclusive at the time of study screening;
- American Society of Anesthesiologists (ASA) Class I-III (Appendix III);
- Due to undergo ileostomy or colostomy creation via laparotomy or laparoscopy;
Exclusion Criteria:
- Mentally incompetent or unable or unwilling to provide informed consent or comply with study procedures;
- American Society of Anesthesiologists (ASA) Class IV or V;
- Children <18 years
Sites / Locations
- Cedars Sinai Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Stoma tube
Standard Stoma
Arm Description
Stoma tube (18 French) red robinson catheter inserted into stoma at the time of surgery
Patients will have standard stoma created without insertion of stoma tube. Stoma tube will only be inserted postoperative if the patient is felt to have postoperative ileus, nausea, vomiting, and decreased stoma output as per standard protocol.
Outcomes
Primary Outcome Measures
Tolerating Low Residue Diet
% 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)
# of hours after surgery at which point first passage of flatus (gas) into stoma bag
Time to Passage of Stool
# of hours after surgery until the patient passes stool into stoma bag
Hospital Discharge
postoperative day after surgery which patient was discharged home
Time to Discharge Based on GI Function
postoperative day which patient is considered ready for discharge based solely on Gastrointestinal function
Major and Minor Medical and Surgical Complications
any major or minor medical and surgical complications after surgery will be recorded
Any Insertion of Nasogastric Tube
insertion of nasogastric tube after surgery will be recorded
Episodes of Vomiting
any episodes of vomiting will be recorded
Diagnosis of Postoperative Ileus
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
Full Information
NCT ID
NCT01911793
First Posted
July 26, 2013
Last Updated
February 6, 2018
Sponsor
Cedars-Sinai Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01911793
Brief Title
Stoma Tube Decompression and Postoperative Ileus After Major Colorectal Surgery
Official Title
Stoma Tube Decompression and Postoperative Ileus After Major Colorectal Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Terminated
Why Stopped
Not enough staff resource to complete study.
Study Start Date
July 2013 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cedars-Sinai Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ileus, Bowel Obstruction
Keywords
stoma, ileus, postoperative, stoma tube
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Stoma tube
Arm Type
Experimental
Arm Description
Stoma tube (18 French) red robinson catheter inserted into stoma at the time of surgery
Arm Title
Standard Stoma
Arm Type
No Intervention
Arm Description
Patients will have standard stoma created without insertion of stoma tube. Stoma tube will only be inserted postoperative if the patient is felt to have postoperative ileus, nausea, vomiting, and decreased stoma output as per standard protocol.
Intervention Type
Device
Intervention Name(s)
Stoma Tube
Other Intervention Name(s)
Red robinson catheter
Intervention Description
Stoma tube will be inserted into stoma at the time of surgery for patients assigned to Stoma Tube group.
Primary Outcome Measure Information:
Title
Tolerating Low Residue Diet
Description
% of patients tolerating a low residue diet on postoperative day 3 will be assessed
Time Frame
by postoperative day 3( 3rd day after surgery)
Secondary Outcome Measure Information:
Title
Time to Flatus (Passing Gas Into Stoma Bag)
Description
# of hours after surgery at which point first passage of flatus (gas) into stoma bag
Time Frame
during 30 day postoperative period
Title
Time to Passage of Stool
Description
# of hours after surgery until the patient passes stool into stoma bag
Time Frame
during 30 day postoperative period
Title
Hospital Discharge
Description
postoperative day after surgery which patient was discharged home
Time Frame
30 day postoperative period
Title
Time to Discharge Based on GI Function
Description
postoperative day which patient is considered ready for discharge based solely on Gastrointestinal function
Time Frame
30 day postoperative period
Title
Major and Minor Medical and Surgical Complications
Description
any major or minor medical and surgical complications after surgery will be recorded
Time Frame
30 day postoperative period
Title
Any Insertion of Nasogastric Tube
Description
insertion of nasogastric tube after surgery will be recorded
Time Frame
30 day postoperative period
Title
Episodes of Vomiting
Description
any episodes of vomiting will be recorded
Time Frame
during postoperative hospital admission (30 day period)
Title
Diagnosis of Postoperative Ileus
Description
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
Time Frame
30 day postoperative period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Able to freely give written informed consent to participate in the study and have signed the Informed Consent Form;
Males or females, 18> years of age and older inclusive at the time of study screening;
American Society of Anesthesiologists (ASA) Class I-III (Appendix III);
Due to undergo ileostomy or colostomy creation via laparotomy or laparoscopy;
Exclusion Criteria:
Mentally incompetent or unable or unwilling to provide informed consent or comply with study procedures;
American Society of Anesthesiologists (ASA) Class IV or V;
Children <18 years
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Phillip Fleshner, MD
Organizational Affiliation
Cedars-Sinai Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedars Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
19610681
Citation
Iyer S, Saunders WB, Stemkowski S. Economic burden of postoperative ileus associated with colectomy in the United States. J Manag Care Pharm. 2009 Jul-Aug;15(6):485-94. doi: 10.18553/jmcp.2009.15.6.485.
Results Reference
background
PubMed Identifier
22576906
Citation
Akesson O, Syk I, Lindmark G, Buchwald P. Morbidity related to defunctioning loop ileostomy in low anterior resection. Int J Colorectal Dis. 2012 Dec;27(12):1619-23. doi: 10.1007/s00384-012-1490-y. Epub 2012 May 11.
Results Reference
background
PubMed Identifier
23183687
Citation
Le Q, Liou DZ, Murrell Z, Fleshner P. Does a history of postoperative ileus predispose to recurrent ileus after multistage ileal pouch-anal anastomosis? Tech Coloproctol. 2013 Aug;17(4):383-8. doi: 10.1007/s10151-012-0942-2. Epub 2012 Nov 27.
Results Reference
background
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Stoma Tube Decompression and Postoperative Ileus After Major Colorectal Surgery
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