Stoma Tube Decompression and Postoperative Ileus After Major Colorectal Surgery

Ileus Clinical Trial

Official title:

Stoma Tube Decompression and Postoperative Ileus After Major Colorectal Surgery

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01911793
• Other study ID #: Stoma Tube Study
• Status: Terminated
• Phase: N/A
• First received: July 26, 2013
• Last updated: February 6, 2018
• Start date: July 2013
• Est. completion date: July 2014

Study information

• Verified date: February 2018
• Source: Cedars-Sinai Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bowel Obstruction
• Ileus
• Intestinal Obstruction

Intervention

Device:
• Stoma Tube
Stoma tube will be inserted into stoma at the time of surgery for patients assigned to Stoma Tube group.

Locations

Country	Name	City	State
United States	Cedars Sinai Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (3)

Åkesson 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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Time to Passage of Stool	# of hours after surgery until the patient passes stool into stoma bag	during 30 day postoperative period
Secondary	Hospital Discharge	postoperative day after surgery which patient was discharged home	30 day postoperative period
Secondary	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
Secondary	Major and Minor Medical and Surgical Complications	any major or minor medical and surgical complications after surgery will be recorded	30 day postoperative period
Secondary	Any Insertion of Nasogastric Tube	insertion of nasogastric tube after surgery will be recorded	30 day postoperative period
Secondary	Episodes of Vomiting	any episodes of vomiting will be recorded	during postoperative hospital admission (30 day period)
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	30 day postoperative period