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Not enough staff resource to complete study.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stoma tube | Experimental | Stoma tube (18 French) red robinson catheter inserted into stoma at the time of surgery |
|
| Standard Stoma | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stoma Tube | Device | Stoma tube will be inserted into stoma at the time of surgery for patients assigned to Stoma Tube group. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tolerating Low Residue Diet | % of patients tolerating a low residue diet on postoperative day 3 will be assessed | by postoperative day 3( 3rd day after surgery) |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Flatus (Passing Gas Into Stoma Bag) | # of hours after surgery at which point first passage of flatus (gas) into stoma bag | during 30 day postoperative period |
| Time to Passage of Stool |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Phillip Fleshner, MD | Cedars-Sinai Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars Sinai Medical Center | Los Angeles | California | 90048 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19610681 | Background | 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. | |
| 22576906 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Stoma Tube | Stoma tube (18 French) red robinson catheter inserted into stoma at the time of surgery Stoma Tube: Stoma tube will be inserted into stoma at the time of surgery for patients assigned to Stoma Tube group. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Data were not collected and no data was analyzed study was terminated due to issues with study enrollment and study administrative coverage.
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| ID | Title | Description |
|---|---|---|
| BG000 | Stoma Tube | Stoma tube (18 French) red robinson catheter inserted into stoma at the time of surgery Stoma Tube: Stoma tube will be inserted into stoma at the time of surgery for patients assigned to Stoma Tube group. |
| BG001 | Standard Stoma |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Tolerating Low Residue Diet | % of patients tolerating a low residue diet on postoperative day 3 will be assessed | Data were not collected and no data was analyzed study was terminated due to issues with study enrollment and study administrative coverage. | Posted | by postoperative day 3( 3rd day after surgery) |
|
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.
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Stoma Tube | Stoma tube (18 French) red robinson catheter inserted into stoma at the time of surgery Stoma Tube: Stoma tube will be inserted into stoma at the time of surgery for patients assigned to Stoma Tube group. |
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Study only accrued 6 patients. Due to poor enrollment and issues with administrative coverage for study it was decided to terminate the study.
NO data analysis has been done and will not be done in the future. This study was closed with the IRB.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Phillip Fleshner, MD | Cedars Sinai Medical Center | 310-289-9224 | pfleshner@aol.com |
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| ID | Term |
|---|---|
| D045823 | Ileus |
| D007415 | Intestinal Obstruction |
| ID | Term |
|---|---|
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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# of hours after surgery until the patient passes stool into stoma bag
| during 30 day postoperative period |
| Hospital Discharge | postoperative day after surgery which patient was discharged home | 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 | 30 day postoperative period |
| Major and Minor Medical and Surgical Complications | any major or minor medical and surgical complications after surgery will be recorded | 30 day postoperative period |
| Any Insertion of Nasogastric Tube | insertion of nasogastric tube after surgery will be recorded | 30 day postoperative period |
| Episodes of Vomiting | any episodes of vomiting will be recorded | 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 | 30 day postoperative period |
| 23183687 | Background | 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. |
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. |
| BG002 | Total | Total of all reporting groups |
|
| Age, Continuous |
| Sex: Female, Male |
|
| Region of Enrollment | participants |
|
|
| Secondary | Time to Flatus (Passing Gas Into Stoma Bag) | # of hours after surgery at which point first passage of flatus (gas) into stoma bag | Data were not collected and no data was analyzed study was terminated due to issues with study enrollment and study administrative coverage. | Posted | during 30 day postoperative period |
|
|
| Secondary | Time to Passage of Stool | # of hours after surgery until the patient passes stool into stoma bag | Data were not collected and no data was analyzed study was terminated due to issues with study enrollment and study administrative coverage. | Posted | during 30 day postoperative period |
|
|
| Secondary | Hospital Discharge | postoperative day after surgery which patient was discharged home | Data were not collected and no data was analyzed study was terminated due to issues with study enrollment and study administrative coverage. | Posted | 30 day postoperative period |
|
|
| Secondary | Time to Discharge Based on GI Function | postoperative day which patient is considered ready for discharge based solely on Gastrointestinal function | Data were not collected and no data was analyzed study was terminated due to issues with study enrollment and study administrative coverage. | Posted | 30 day postoperative period |
|
|
| Secondary | Major and Minor Medical and Surgical Complications | any major or minor medical and surgical complications after surgery will be recorded | Data were not collected and no data was analyzed study was terminated due to issues with study enrollment and study administrative coverage. | Posted | 30 day postoperative period |
|
|
| Secondary | Any Insertion of Nasogastric Tube | insertion of nasogastric tube after surgery will be recorded | Data were not collected and no data was analyzed study was terminated due to issues with study enrollment and study administrative coverage. | Posted | 30 day postoperative period |
|
|
| Secondary | Episodes of Vomiting | any episodes of vomiting will be recorded | Data were not collected and no data was analyzed study was terminated due to issues with study enrollment and study administrative coverage. | Posted | during postoperative hospital admission (30 day period) |
|
|
| Secondary | 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 | Data were not collected and no data was analyzed study was terminated due to issues with study enrollment and study administrative coverage. | Posted | 30 day postoperative period |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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. | 0 | 0 | 0 | 0 |
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