IleusNCT01911793

Stoma Tube Decompression and Postoperative Ileus After Major Colorectal Surgery

A study testing Stoma Tube in people with Ileus and Bowel Obstruction, run by Cedars-Sinai Medical Center at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Ileus, Bowel Obstruction
What is being tested?: Stoma Tube
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 6 participants
Where: 1 siteUnited States
Study dates: Jul 2013to Jul 2014
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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;

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Cedars Sinai Medical Center
Los Angeles, California, 90048

Other trials in United States

About this study

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
Being tested: Stoma Tube
Keywords: stoma, ileus, postoperative, stoma tube
Medical subject headings: Ileus, Intestinal Obstruction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Stoma TubeDevice
Also called Red robinson catheter
Stoma tube will be inserted into stoma at the time of surgery for patients assigned to Stoma Tube group.

Study groups in NCT01911793
Study group	Role	What they receive
Stoma tube	Experimental	Stoma tube (18 French) red robinson catheter inserted into stoma at the time of surgery Receives: 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

Tolerating Low Residue Diet
% of patients tolerating a low residue diet on postoperative day 3 will be assessed
Measured: by postoperative day 3( 3rd day after surgery)

Secondary outcomes (8)

Time to Flatus (Passing Gas Into Stoma Bag)
# of hours after surgery at which point first passage of flatus (gas) into stoma bag
Measured: during 30 day postoperative period
Time to Passage of Stool
# of hours after surgery until the patient passes stool into stoma bag
Measured: during 30 day postoperative period
Hospital Discharge
postoperative day after surgery which patient was discharged home
Measured: 30 day postoperative period
Time to Discharge Based on GI Function
postoperative day which patient is considered ready for discharge based solely on Gastrointestinal function
Measured: 30 day postoperative period
Major and Minor Medical and Surgical Complications
any major or minor medical and surgical complications after surgery will be recorded
Measured: 30 day postoperative period
Any Insertion of Nasogastric Tube
insertion of nasogastric tube after surgery will be recorded
Measured: 30 day postoperative period
Episodes of Vomiting
any episodes of vomiting will be recorded
Measured: during postoperative hospital admission (30 day period)
Diagnosis of Postoperative Ileus
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
Measured: 30 day postoperative period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2013Jul 2014

First posted30 Jul 2013 (estimated)
Study startJul 2013
Primary completionJul 2014
Study completionJul 2014

Why it stopped: Not enough staff resource to complete study.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for IleusStudies of the same condition, open and under way.
More trials run by Cedars-Sinai Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 6 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01911793
Sponsor's protocol ID: Stoma Tube Study
Status last verified: Feb 2018
First submitted: 26 Jul 2013
Last updated: 7 Mar 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 19610681
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.
PubMed 22576906
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.
PubMed 23183687

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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The Effect of Ostomy Care Education Applied With the Teach-Back Method to Ostomy-Opened Individuals on Self-Care Power, Ostomy Adjustment, and Anxiety
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All Ileus trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Stoma Tube Decompression and Postoperative Ileus After Major Colorectal Surgery
ClinicalTrials.gov ID: NCT01911793
Acronym / sponsor ID: Stoma Tube Study
Conditions: Ileus, Bowel Obstruction
Keywords: stoma, ileus, postoperative, stoma tube
Study type: Interventional
Recruitment status: TerminatedReason stopped: Not enough staff resource to complete study.
Enrolment: 6 participants (actual)
Lead sponsor: Cedars-Sinai Medical CenterUniversity, hospital or other
Study start: Jul 2013
Primary completion: Jul 2014 (actual)
Study completion: Jul 2014 (actual)
First posted: 30 Jul 2013 (estimated)
Results: Posted 28 Jun 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Stoma tube	Experimental	Device: Stoma TubeStoma tube (18 French) red robinson catheter inserted into stoma at the time of surgery
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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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;

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Stoma TubeAlso: Red robinson catheterStoma tube will be inserted into stoma at the time of surgery for patients assigned to Stoma Tube group.	Device	Stoma tube

Primary outcome

Tolerating Low Residue Diet
Time frame: by postoperative day 3( 3rd day after surgery)
% of patients tolerating a low residue diet on postoperative day 3 will be assessed

8 secondary outcomes

Time to Flatus (Passing Gas Into Stoma Bag)
Time frame: during 30 day postoperative period
Time to Passage of Stool
Time frame: during 30 day postoperative period
Hospital Discharge
Time frame: 30 day postoperative period
Time to Discharge Based on GI Function
Time frame: 30 day postoperative period
Major and Minor Medical and Surgical Complications
Time frame: 30 day postoperative period
Any Insertion of Nasogastric Tube
Time frame: 30 day postoperative period
Episodes of Vomiting
Time frame: during postoperative hospital admission (30 day period)
Diagnosis of Postoperative Ileus
Time frame: 30 day postoperative period

Results and safety

Results posted to the registry on 28 Jun 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Stoma Tube	1	0
Standard Stoma	5	0

Primary outcome: Tolerating Low Residue Diet

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

Population analysed: Data were not collected and no data was analyzed study was terminated due to issues with study enrollment and study administrative coverage.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Data were not collected and no data was analyzed study was terminated due to issues with study enrollment and study administrative coverage. Total Number of Participants at Risk (e.g., "All-Cause Mortality, Serious, and Other [Not Including Serious] Adverse Events were not monitored/assessed for this study.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Stoma Tube	0 of 0	0 of 0	Not reported
Standard Stoma	0 of 0	0 of 0	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 19610681Iyer 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.
Background: PubMed 22576906Akesson 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.
Background: PubMed 23183687Le 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.

Related trials for Ileus

Recruiting
Rectus Sheath Catheters Following Midline Laparotomy
Acute Abdomen, Ileus
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingObservational study
At-Home Bowel Stimulation
Post-Operative Ileus (POI)
Recruiting
The Food Network Effect
Post Operative Patients
RecruitingObservational study
The Effect of Ostomy Care Education Applied With the Teach-Back Method to Ostomy-Opened Individuals on Self-Care Power, Ostomy Adjustment, and Anxiety
Ostomy - Ileostomy or Colostomy, Canser

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Phillip Fleshner, MD principal investigator

Cedars-Sinai Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Stoma Tube in people with Ileus and Bowel Obstruction, run by Cedars-Sinai Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 7 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tolerating Low Residue Diet (time frame: by postoperative day 3( 3rd day after surgery)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01911793, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2018.