NCT02178228

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

Prospective Assessment of Anastomotic Leak

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,077 (actual)
• Sponsor: Icahn School of Medicine at Mount Sinai · Academic / Other
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The objective of this study is to identify peri-operative factors that contribute to leaks after a portion of the bowel has been cut and reconnected. Most specifically, the role of staplers in this reconnection of the bowels will be evaluated. The research will take place at Icahn School of Medicine where there is an extremely high volume of operations involving small bowel and large bowel being cut and reconnected. Patients will be recruited based on inclusion and exclusion criteria and 500 subjects are expected to be enrolled in the study. The surgery will be performed in a standard fashion as indicated by diagnosis, location of disease, patient condition, and surgeon preference. No changes to the surgical procedure will be mandated by the research protocol. This is purely an observational study with no changes to the standard of care. The patients will be followed throughout the course of the their hospital stay for the scheduled surgery up to one week and one month after the procedure to gather laboratory data and any complications incurred due to the surgery. No patient specimen will be stored. The staplers used in the procedure will be collected, stored in sterile plastic container, information about the staplers will be recorded, and then discarded after 30 days in the usual manner that the operating room staff employs to discard the staplers. Subjects lost to follow-up after the procedure will be withdrawn from the study.

Conditions

• Anastomotic Leaks

Timeline

• Start date: 2013-10-01
• Primary completion: 2018-01-31
• Completion: 2018-01-31
• First posted: 2014-06-30
• Last updated: 2018-02-05

Locations

1 site across 1 country: United States