An interventional study of Stoma Tube in Ileus and Bowel Obstruction, sponsored by Cedars-Sinai Medical Center. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-03-07.
Sponsored by Cedars-Sinai Medical Center · Not applicable, Interventional, and Prevention
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.
124 studies on the registry are indexed under Ileus; 12 are open to participants now.
This study's enrollment of 6 is below the median of 97 across 106 interventional studies indexed under Ileus.
Browse Ileus studies →Cedars-Sinai Medical Center is the lead sponsor of 442 studies on the registry; 109 are open to participants now.
Of its 62 completed or terminated interventional studies of FDA-regulated products, 47 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Stoma tube (18 French) red robinson catheter inserted into stoma at the time of surgery
Device: Stoma Tube
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.
Stoma tube will be inserted into stoma at the time of surgery for patients assigned to Stoma Tube group.
Also known as: Red robinson catheter
Tolerating Low Residue Diet
% of patients tolerating a low residue diet on postoperative day 3 will be assessed
Time frame: by postoperative day 3( 3rd day after surgery)
Time to Flatus (Passing Gas Into Stoma Bag)
# of hours after surgery at which point first passage of flatus (gas) into stoma bag
Time frame: during 30 day postoperative period
Time to Passage of Stool
# of hours after surgery until the patient passes stool into stoma bag
Time frame: during 30 day postoperative period
Hospital Discharge
postoperative day after surgery which patient was discharged home
Time frame: 30 day postoperative period
Time to Discharge Based on GI Function
postoperative day which patient is considered ready for discharge based solely on Gastrointestinal function
Time frame: 30 day postoperative period
Major and Minor Medical and Surgical Complications
any major or minor medical and surgical complications after surgery will be recorded
Time frame: 30 day postoperative period
Any Insertion of Nasogastric Tube
insertion of nasogastric tube after surgery will be recorded
Time frame: 30 day postoperative period
Episodes of Vomiting
any episodes of vomiting will be recorded
Time frame: during postoperative hospital admission (30 day period)
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
Time frame: 30 day postoperative period
| Milestone | Stoma Tube | Standard Stoma |
|---|---|---|
| Started | 1 | 5 |
| Completed | 0 | 0 |
| Not completed | 1 | 5 |
| Withdrew: Physician decision | 1 | 5 |
% of patients tolerating a low residue diet on postoperative day 3 will be assessed
No measurements were reported for this outcome.
# of hours after surgery at which point first passage of flatus (gas) into stoma bag
No measurements were reported for this outcome.
# of hours after surgery until the patient passes stool into stoma bag
No measurements were reported for this outcome.
postoperative day after surgery which patient was discharged home
No measurements were reported for this outcome.
postoperative day which patient is considered ready for discharge based solely on Gastrointestinal function
No measurements were reported for this outcome.
any major or minor medical and surgical complications after surgery will be recorded
No measurements were reported for this outcome.
insertion of nasogastric tube after surgery will be recorded
No measurements were reported for this outcome.
any episodes of vomiting will be recorded
No measurements were reported for this outcome.
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
No measurements were reported for this outcome.
Collected over Data were not collected and no data was analyzed study was terminated due to issues with study enrollment and study administrative coverage. Total Number of Participants at Risk (e.g., "All-Cause Mortality, Serious, and Other [Not Including Serious] Adverse Events were not monitored/assessed for this study.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Stoma Tube | — | — | — |
| Standard Stoma | — | — | — |
Data were not collected and no data was analyzed study was terminated due to issues with study enrollment and study administrative coverage.
| Age, Categorical | Stoma Tube | Standard Stoma | Total |
|---|---|---|---|
| <=18 years | — | — | — |
| Between 18 and 65 years | — | — | — |
| >=65 years | — | — | — |
| Age, Continuous | Stoma Tube | Standard Stoma | Total |
|---|
| Sex: Female, Male | Stoma Tube | Standard Stoma | Total |
|---|---|---|---|
| Female | — | — | — |
| Male | — | — | — |
| Region of Enrollment(participants) | Stoma Tube | Standard Stoma | Total |
|---|
This study is terminated, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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Cedars-Sinai Medical Center