Stoma Tube Decompression and Postoperative Ileus After Major Colorectal Surgery

Cedars-Sinai Medical Center

Status: Terminated

Conditions: Ileus; Bowel Obstruction

Treatments: Device: Stoma Tube

Study type: Interventional

Funder types: Other

Identifiers

NCT01911793

Stoma Tube Study

Details and patient eligibility

About

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.

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

6 participants in 2 patient groups

Stoma tube

Experimental group

Description:

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

Treatment:

Device: Stoma Tube

Standard Stoma

No Intervention group

Description:

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.