MedPath

Stoma Tube Decompression and Postoperative Ileus After Major Colorectal Surgery

Not Applicable
Terminated
Conditions
Ileus
Bowel Obstruction
Interventions
Device: Stoma Tube
Registration Number
NCT01911793
Lead Sponsor
Cedars-Sinai Medical Center
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
6
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Stoma tubeStoma TubeStoma tube (18 French) red robinson catheter inserted into stoma at the time of surgery
Primary Outcome Measures
NameTimeMethod
Tolerating Low Residue Dietby postoperative day 3( 3rd day after surgery)

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

Secondary Outcome Measures
NameTimeMethod
Time to Flatus (Passing Gas Into Stoma Bag)during 30 day postoperative period

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

Time to Passage of Stoolduring 30 day postoperative period

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

Hospital Discharge30 day postoperative period

postoperative day after surgery which patient was discharged home

Time to Discharge Based on GI Function30 day postoperative period

postoperative day which patient is considered ready for discharge based solely on Gastrointestinal function

Major and Minor Medical and Surgical Complications30 day postoperative period

any major or minor medical and surgical complications after surgery will be recorded

Any Insertion of Nasogastric Tube30 day postoperative period

insertion of nasogastric tube after surgery will be recorded

Episodes of Vomitingduring postoperative hospital admission (30 day period)

any episodes of vomiting will be recorded

Diagnosis of Postoperative Ileus30 day postoperative period

diagnosis of postoperative ileus or bowel obstruction made by attending surgeon based on clinical data including abdominal distention, nausea/vomiting, decreased stom output and radiologic factors

Trial Locations

Locations (1)

Cedars Sinai Medical Center

🇺🇸

Los Angeles, California, United States

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