Stoma Tube Decompression and Postoperative Ileus After Major Colorectal Surgery

NCT01911793 | Terminated Results

• 1 other identifier: Stoma Tube Study
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Ileus; Bowel Obstruction

Keywords

stoma; ileus; postoperative; stoma tube

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Time to Flatus (Passing Gas Into Stoma Bag)

  during 30 day postoperative period

• Time to Passage of Stool

  during 30 day postoperative period

• Hospital Discharge

  30 day postoperative period

• Time to Discharge Based on GI Function

  30 day postoperative period

• Major and Minor Medical and Surgical Complications

  30 day postoperative period

Study Arms (2)

Stoma tube

EXPERIMENTAL

Stoma tube (18 French) red robinson catheter inserted into stoma at the time of surgery

Device: Stoma Tube

Standard Stoma

NO INTERVENTION

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.

Interventions

Stoma Tube DEVICE

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

Also known as: Red robinson catheter

Stoma tube

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Related Publications (3)

• 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.

  PMID: 19610681 BACKGROUND

• 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.

  PMID: 22576906 BACKGROUND

• 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.

  PMID: 23183687 BACKGROUND

MeSH Terms

Conditions

Ileus; Intestinal Obstruction

Condition Hierarchy (Ancestors)

Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Limitations and Caveats

Study only accrued 6 patients. Due to poor enrollment and issues with administrative coverage for study it was decided to terminate the study. NO data analysis has been done and will not be done in the future. This study was closed with the IRB.

Results Point of Contact

• Title: Phillip Fleshner, MD
• Organization: Cedars Sinai Medical Center

pfleshner@aol.com

310-289-9224

Study Officials

• Phillip Fleshner, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Colorectal Surgery Residency

Study Record Dates

• First Submitted: July 26, 2013
• First Posted: July 30, 2013
• Study Start: July 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: March 7, 2018
• Results First Posted: June 28, 2017

Record last verified: 2018-02

Locations

US (1)