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 Overview

• Status: Terminated
• Conditions: Ileus; Bowel Obstruction
• Intervention / Treatment: Device: Stoma Tube

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Cedars Sinai Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Red robinson catheter
No Intervention: Standard Stoma; 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?

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

Collaborators and Investigators

• Sponsor: Cedars-Sinai Medical Center

Publications and helpful links

General Publications

• Iyer S, Saunders WB, Stemkowski S. Economic burden of postoperative ileus associated with colectomy in the United States. J Manag Care Pharm. 2009 Jul-Aug;15(6):485-94. doi: 10.18553/jmcp.2009.15.6.485.
• Akesson O, Syk I, Lindmark G, Buchwald P. Morbidity related to defunctioning loop ileostomy in low anterior resection. Int J Colorectal Dis. 2012 Dec;27(12):1619-23. doi: 10.1007/s00384-012-1490-y. Epub 2012 May 11.
• Le Q, Liou DZ, Murrell Z, Fleshner P. Does a history of postoperative ileus predispose to recurrent ileus after multistage ileal pouch-anal anastomosis? Tech Coloproctol. 2013 Aug;17(4):383-8. doi: 10.1007/s10151-012-0942-2. Epub 2012 Nov 27.

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: July 26, 2013
• First Submitted That Met QC Criteria: July 29, 2013
• First Posted (Estimate): July 30, 2013

Study Record Updates

• Last Update Posted (Actual): March 7, 2018
• Last Update Submitted That Met QC Criteria: February 6, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: postoperative; ileus; stoma; stoma tube
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Ileus; Intestinal Obstruction
• Other Study ID Numbers: Stoma Tube Study