Stoma Tube Decompression and Postoperative Ileus After Major Colorectal Surgery

Study Overview
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Brief Summary
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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.

Official Title
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Stoma Tube Decompression and Postoperative Ileus After Major Colorectal Surgery

Conditions
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Bowel Obstruction, Ileus

Intervention / Treatment
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* Device: Stoma Tube


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able to freely give written informed consent to participate in the study and have signed the Informed Consent Form; Males or females, 18> years of age and older inclusive at the time of study screening; American Society of Anesthesiologists (ASA) Class I-III (Appendix III); Due to undergo ileostomy or colostomy creation via laparotomy or laparoscopy; Exclusion Criteria: Mentally incompetent or unable or unwilling to provide informed consent or comply with study procedures; American Society of Anesthesiologists (ASA) Class IV or V; Children <18 years

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stoma tube<br>Stoma tube (18 French) red robinson catheter inserted into stoma at the time of surgery | Device: Stoma Tube<br>* Stoma tube will be inserted into stoma at the time of surgery for patients assigned to Stoma Tube group.<br>* Other names: Red robinson catheter;|
| No Intervention: Standard Stoma<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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 | # 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stoma, ileus, postoperative, stoma tube