Observational Analysis of the Cause of Leaks When Bowel is Cut and Reconnected

Completed

Conditions studied: Anastomotic Leaks

In brief

The purpose of this study is to identify the cause of leaks that sometimes occur after a section of the bowel is removed and reconnected. Certain staplers from the operating room will be collected and sent to a third party (ECRI Institute) to be examined for defects. The patient's charts will be analyzed for medical issues that may contribute to leaks after surgery.

Key facts

Study ID

NCT02178228

Run by

Icahn School of Medicine at Mount Sinai

People needed

1077

Starts

2013-10-01

Expected to finish

2018-01-31

Last updated by the study team

2018-02-05

Who can join

Age: 15 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject must be scheduled for non-emergent small or large bowel surgery and reconnection of bowel at Icahn School of Medicine at Mount Sinai
• Subjects must be able and willing to provide informed consent
• Subjects must be 18 years or above OR 15-17 with permission of one parent
• English and Spanish speaking patients will be included in this study

You may not qualify if…

• Subject who are less than 15 years of age
• Subject who are scheduled for emergent surgery, precluding the capacity to give informed consent
• Subjects who are diagnosed with obstructed or perforated colon cancer

Where it is running

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

Full record on ClinicalTrials.gov

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