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CompletedNCT03909542Updated Apr 10, 2019

Malnutrition Associated With Complications After Ileostomy Reversal

An observational study in Inflammatory Bowel Diseases and Ileostomy, sponsored by Icahn School of Medicine at Mount Sinai. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2019-04-10.

Sponsored by Icahn School of Medicine at Mount Sinai · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
359
Sex
All
01

Study 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.

Read the 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.

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Conditions studied

  • Inflammatory Bowel Diseases
  • Ileostomy

Keywords

  • inflammatory bowel disease
  • ileostomy
  • ileostomy reversal
  • stoma reversal
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In context

Intestinal Diseases

963 studies on the registry are indexed under Intestinal Diseases; 174 are open to participants now.

This study's enrollment of 359 is above the median of 140 across 377 observational studies indexed under Intestinal Diseases.

Browse Intestinal Diseases studies →

Lead sponsor

Icahn School of Medicine at Mount Sinai is the lead sponsor of 764 studies on the registry; 181 are open to participants now.

Of its 121 completed or terminated interventional studies of FDA-regulated products, 82 (68%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Patients who have had an ileostomy closure procedure

Inclusion criteria

  • ileostomy closure procedure

Exclusion criteria

Exclusion Criteria:

  • none
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
359 participants (actual)
Patient registry
No

Groups and cohorts

  • Ileostomy Closure

    Patients who have undergone an ileostomy closure procedure.

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What researchers measure

Primary outcomes

  1. Number of Complications

    Number of any post operative complication

    Time frame: up to 5 years

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Study locations

1 site
  • Icahn School of Medicine at Mount Sinai
    New York, New York 10029, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 10, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03909542
Lead sponsor
Icahn School of Medicine at Mount Sinai
Responsible party
Joel Bauer (Dr. Joel J Bauer MD, Professor of Surgery, Icahn School of Medicine at Mount Sinai) — Principal investigator
First posted
Apr 10, 2019
Start date
Mar 2015
Primary completion
Mar 5, 2018
Completion
Mar 5, 2018
Last update
Apr 10, 2019

Study contacts

Joel J Bauer, MD
principal investigator · Icahn School of Medicine at Mount Sinai

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

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