Stoma Tube Decompression and Postoperative Ileus After Major Colorectal Surgery

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2014-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Ileus Bowel Obstruction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Stoma tube

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

Group Type EXPERIMENTAL

Stoma Tube

Intervention Type DEVICE

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

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Stoma Tube

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

Intervention Type DEVICE

Other Intervention Names

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Red robinson catheter

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No