Stoma Tube Decompression and Postoperative Ileus After Major Colorectal Surgery
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Stoma Tube Decompression and Postoperative Ileus After Major Colorectal Surgery|
- Tolerating low residue diet [ Time Frame: by postoperative day 3( 3rd day after surgery) ] [ Designated as safety issue: No ]% 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 ] [ Designated as safety issue: No ]# 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 ] [ Designated as safety issue: No ]# of hours after surgery until the patient passes stool into stoma bag
- hospital discharge [ Time Frame: 30 day postoperative period ] [ Designated as safety issue: No ]postoperative day after surgery which patient was discharged home
- time to discharge based on GI function [ Time Frame: 30 day postoperative period ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: Yes ]any major or minor medical and surgical complications after surgery will be recorded
- any insertion of nasogastric tube [ Time Frame: 30 day postoperative period ] [ Designated as safety issue: No ]insertion of nasogastric tube after surgery will be recorded
- episodes of vomiting [ Time Frame: during postoperative hospital admission (30 day period) ] [ Designated as safety issue: No ]any episodes of vomiting will be recorded
- diagnosis of postoperative ileus [ Time Frame: 30 day postoperative period ] [ Designated as safety issue: No ]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
|Study Start Date:||July 2013|
|Study Completion Date:||July 2014|
|Primary Completion Date:||July 2014 (Final data collection date for primary outcome measure)|
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 postopertively if the patient is felt to have postopeprative ileus, nausea, vomiting, and decreased stoma output as per standard protocol.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01911793
|United States, California|
|Cedars Sinai Medical Center|
|Los Angeles, California, United States, 90048|
|Principal Investigator:||Phillip Fleshner, MD||Cedars-Sinai Medical Center|