Bowel Obstruction, Ileus
Conditions
Keywords
stoma, ileus, postoperative, stoma tube
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.
Interventions
DEVICEStoma Tube
Stoma tube will be inserted into stoma at the time of surgery for patients assigned to Stoma Tube group.
Sponsors
Cedars-Sinai Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Able to freely give written informed consent to participate in the study and have signed the Informed Consent Form; 2. Males or females, 18\> years of age and older inclusive at the time of study screening; 3. American Society of Anesthesiologists (ASA) Class I-III (Appendix III); 4. Due to undergo ileostomy or colostomy creation via laparotomy or laparoscopy;
Exclusion criteria
1. Mentally incompetent or unable or unwilling to provide informed consent or comply with study procedures; 2. American Society of Anesthesiologists (ASA) Class IV or V; 3. Children \<18 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tolerating Low Residue Diet | by postoperative day 3( 3rd day after surgery) | % of patients tolerating a low residue diet on postoperative day 3 will be assessed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Flatus (Passing Gas Into Stoma Bag) | 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 | during 30 day postoperative period | \# of hours after surgery until the patient passes stool into stoma bag |
| Hospital Discharge | 30 day postoperative period | postoperative day after surgery which patient was discharged home |
| Time to Discharge Based on GI Function | 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 | 30 day postoperative period | any major or minor medical and surgical complications after surgery will be recorded |
| Any Insertion of Nasogastric Tube | 30 day postoperative period | insertion of nasogastric tube after surgery will be recorded |
| Episodes of Vomiting | during postoperative hospital admission (30 day period) | any episodes of vomiting will be recorded |
| Diagnosis of Postoperative Ileus | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 0 |
| 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 |
| Total | 0 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 1 | 5 |
Baseline characteristics
| Characteristic | — |
|---|---|
| Region of Enrollment United States | — participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
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)
Population: Data were not collected and no data was analyzed study was terminated due to issues with study enrollment and study administrative coverage.
Secondary
Any Insertion of Nasogastric Tube
insertion of nasogastric tube after surgery will be recorded
Time frame: 30 day postoperative period
Population: Data were not collected and no data was analyzed study was terminated due to issues with study enrollment and study administrative coverage.
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
Time frame: 30 day postoperative period
Population: Data were not collected and no data was analyzed study was terminated due to issues with study enrollment and study administrative coverage.
Secondary
Episodes of Vomiting
any episodes of vomiting will be recorded
Time frame: during postoperative hospital admission (30 day period)
Population: Data were not collected and no data was analyzed study was terminated due to issues with study enrollment and study administrative coverage.
Secondary
Hospital Discharge
postoperative day after surgery which patient was discharged home
Time frame: 30 day postoperative period
Population: Data were not collected and no data was analyzed study was terminated due to issues with study enrollment and study administrative coverage.
Secondary
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
Population: Data were not collected and no data was analyzed study was terminated due to issues with study enrollment and study administrative coverage.
Secondary
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
Population: Data were not collected and no data was analyzed study was terminated due to issues with study enrollment and study administrative coverage.
Secondary
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
Population: Data were not collected and no data was analyzed study was terminated due to issues with study enrollment and study administrative coverage.
Secondary
Time to Passage of Stool
\# of hours after surgery until the patient passes stool into stoma bag
Time frame: during 30 day postoperative period
Population: Data were not collected and no data was analyzed study was terminated due to issues with study enrollment and study administrative coverage.