Malnutrition Associated With Complications After Ileostomy Reversal

Postoperative Complications in Patients With Inflammatory Bowel Disease: A Retrospective Cohort Study

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.

Study Overview

• Status: Completed
• Conditions: 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 Type: Observational
• Enrollment (Actual): 359

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who have had an ileostomy closure procedure

Description

Inclusion Criteria:

• ileostomy closure procedure

Exclusion Criteria:

• none

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Ileostomy Closure; Patients who have undergone an ileostomy closure procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Complications	Number of any post operative complication	up to 5 years

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Investigators: Principal Investigator: Joel J Bauer, MD, Icahn School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2015
• Primary Completion (Actual): March 5, 2018
• Study Completion (Actual): March 5, 2018

Study Registration Dates

• First Submitted: April 8, 2019
• First Submitted That Met QC Criteria: April 8, 2019
• First Posted (Actual): April 10, 2019

Study Record Updates

• Last Update Posted (Actual): April 10, 2019
• Last Update Submitted That Met QC Criteria: April 8, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: ileostomy; inflammatory bowel disease; stoma reversal; ileostomy reversal
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Intestinal Diseases
• Other Study ID Numbers: GCO 16-0139

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No