Stoma Tube Decompression and Postoperative Ileus After Major Colorectal Surgery
- Conditions
- IleusBowel Obstruction
- Interventions
- Device: Stoma Tube
- Registration Number
- NCT01911793
- Lead Sponsor
- Cedars-Sinai Medical Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 6
- 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;
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Stoma tube Stoma Tube Stoma tube (18 French) red robinson catheter inserted into stoma at the time of surgery
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Cedars Sinai Medical Center
🇺🇸Los Angeles, California, United States