Clinical trial NCT01911793: Stoma Tube Decompression and Postoperative Ileus After Major Colorectal Surgery
Official title: Stoma Tube Decompression and Postoperative Ileus After Major Colorectal Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Ileus
Bowel Obstruction
Keywords: stoma
ileus
postoperative
stoma tube
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2013-07-30
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Tolerating Low Residue Diet
timeFrame: by postoperative day 3( 3rd day after surgery)
Secondary outcomes:
measure: Time to Flatus (Passing Gas Into Stoma Bag)
timeFrame: during 30 day postoperative period
measure: Time to Passage of Stool
timeFrame: during 30 day postoperative period
measure: Hospital Discharge
timeFrame: 30 day postoperative period
measure: Time to Discharge Based on GI Function
timeFrame: 30 day postoperative period
measure: Major and Minor Medical and Surgical Complications
timeFrame: 30 day postoperative period
measure: Any Insertion of Nasogastric Tube
timeFrame: 30 day postoperative period
measure: Episodes of Vomiting
timeFrame: during postoperative hospital admission (30 day period)
measure: Diagnosis of Postoperative Ileus
timeFrame: 30 day postoperative period
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Phillip Fleshner, MD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.18553/jmcp.2009.15.6.485.
citation: 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.
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.