Stoma Tube Decompression and Postoperative Ileus After Major Colorectal Surgery
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|ClinicalTrials.gov Identifier: NCT01911793|
Recruitment Status : Terminated (Not enough staff resource to complete study.)
First Posted : July 30, 2013
Results First Posted : June 28, 2017
Last Update Posted : March 7, 2018
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 or disease||Intervention/treatment|
|Ileus Bowel Obstruction||Device: Stoma Tube|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Stoma Tube Decompression and Postoperative Ileus After Major Colorectal Surgery|
|Study Start Date :||July 2013|
|Primary Completion Date :||July 2014|
|Study Completion Date :||July 2014|
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 postoperative if the patient is felt to have postoperative ileus, nausea, vomiting, and decreased stoma output as per standard protocol.
- Tolerating Low Residue Diet [ Time Frame: by postoperative day 3( 3rd day after surgery) ]% of patients tolerating a low residue diet on postoperative day 3 will be assessed
- Time to Flatus (Passing Gas Into Stoma Bag) [ Time Frame: during 30 day postoperative period ]# 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 ]# of hours after surgery until the patient passes stool into stoma bag
- Hospital Discharge [ Time Frame: 30 day postoperative period ]postoperative day after surgery which patient was discharged home
- Time to Discharge Based on GI Function [ Time Frame: 30 day postoperative period ]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 ]any major or minor medical and surgical complications after surgery will be recorded
- Any Insertion of Nasogastric Tube [ Time Frame: 30 day postoperative period ]insertion of nasogastric tube after surgery will be recorded
- Episodes of Vomiting [ Time Frame: during postoperative hospital admission (30 day period) ]any episodes of vomiting will be recorded
- Diagnosis of Postoperative Ileus [ Time Frame: 30 day postoperative period ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01911793
|United States, California|
|Cedars Sinai Medical Center|
|Los Angeles, California, United States, 90048|
|Principal Investigator:||Phillip Fleshner, MD||Cedars-Sinai Medical Center|