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Malnutrition Associated With Complications After Ileostomy Reversal

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03909542
Recruitment Status : Completed
First Posted : April 10, 2019
Last Update Posted : April 10, 2019
Sponsor:
Information provided by (Responsible Party):
Joel Bauer, Icahn School of Medicine at Mount Sinai

Study Description
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Brief Summary:
An ileostomy is a surgical opening established by bringing the end or a loop of the ileum to discharge directly outside the body. This is typically done when part or the entire colon is removed because of IBD, cancer, or familial adenomatous polyposis. Reversal of this procedure, an ileostomy closure, may be done if possible. Ileostomy closure involves reconnecting the ileum to the remaining colon, allowing normal bowel movements again. This study will look at the outcomes of these surgeries in patients who were seen and operated on by the investigators.

Condition or disease
Inflammatory Bowel Diseases Ileostomy

Detailed Description:
This study focused on outcomes and complications after ileostomy closure. An ileostomy is a surgical opening established by bringing the end or a loop of the ileum to discharge directly outside the body. This is typically done when part or the entire colon is removed because of IBD, cancer, or familial adenomatous polyposis. Reversal of this procedure, an ileostomy closure, may be done if possible to reconnect the ileum to the remaining colon and allow normal bowel movements again. This study looked at the outcomes for these surgeries in patients who were seen and operated on by the investigators. Patients were identified from the files and schedules of the investigators, and Epic was used to collect the information needed to determine perioperative clinical characteristics and post-operative outcomes. This data was kept in a secure electronic database, with identifiers removed as soon as all of the data was collected for a patient.
Study Design
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Study Type : Observational
Actual Enrollment : 359 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Postoperative Complications in Patients With Inflammatory Bowel Disease: A Retrospective Cohort Study
Actual Study Start Date : March 2015
Actual Primary Completion Date : March 5, 2018
Actual Study Completion Date : March 5, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: After Surgery

Groups and Cohorts
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Group/Cohort
Ileostomy Closure
Patients who have undergone an ileostomy closure procedure.


Outcome Measures
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Primary Outcome Measures :
  1. Number of Complications [ Time Frame: up to 5 years ]
    Number of any post operative complication


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients who have had an ileostomy closure procedure
Criteria

Inclusion Criteria:

  • ileostomy closure procedure

Exclusion Criteria:

  • none
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03909542


Locations
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United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Investigators
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Principal Investigator: Joel J Bauer, MD Icahn School of Medicine at Mount Sinai
More Information
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Responsible Party: Joel Bauer, Dr. Joel J Bauer MD, Professor of Surgery, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT03909542    
Other Study ID Numbers: GCO 16-0139
First Posted: April 10, 2019    Key Record Dates
Last Update Posted: April 10, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Joel Bauer, Icahn School of Medicine at Mount Sinai:
inflammatory bowel disease
ileostomy
ileostomy reversal
stoma reversal
Additional relevant MeSH terms:
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Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis