Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2025-12-26 @ 12:34 AM
Study NCT ID:
NCT01911793
Status:
TERMINATED
Last Update Posted:
2018-03-07
First Post:
2013-07-26
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Stoma Tube Decompression and Postoperative Ileus After Major Colorectal Surgery
Sponsor:
Cedars-Sinai Medical Center
Organization:
Study Overview
Official Title:
Stoma Tube Decompression and Postoperative Ileus After Major Colorectal Surgery
Status:
TERMINATED
Status Verified Date:
2018-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not enough staff resource to complete study.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: