Stoma Tube Decompression and Postoperative Ileus After Major Colorectal Surgery

N/ATerminatedNCT01911793

Cedars-Sinai Medical Center6 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Ileus Bowel Obstruction

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Tolerating Low Residue Diet

% of patients tolerating a low residue diet on postoperative day 3 will be assessed

Time frame: by postoperative day 3( 3rd day after surgery)

Secondary Outcomes

Time to Flatus (Passing Gas Into Stoma Bag)

\# of hours after surgery at which point first passage of flatus (gas) into stoma bag

Time frame: during 30 day postoperative period

Time to Passage of Stool

\# of hours after surgery until the patient passes stool into stoma bag

Time frame: during 30 day postoperative period

Hospital Discharge

postoperative day after surgery which patient was discharged home