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

Anastomotic Leaks Clinical Trial

Official title:

Prospective Assessment of Anastomotic Leak

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02178228
• Other study ID #: GCO 09-2235
• Status: Completed
• Phase: N/A
• First received: June 26, 2014
• Last updated: February 2, 2018
• Start date: October 2013
• Est. completion date: January 31, 2018

Study information

• Verified date: February 2018
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 Subjects lost to follow-up after the procedure will be withdrawn from the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1077
• Est. completion date: January 31, 2018
• Est. primary completion date: January 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Anastomotic Leak
• Anastomotic Leaks

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	ECRI Institute, Medtronic - MITG

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All cause bowel leaks after surgery		one week post-operation
Primary	All cause bowel leaks after surgery		one month post-operation
Secondary	Reoperation		1 year post operation
Secondary	Sepsis		1 year post operation
Secondary	Length of hospital stay		1 year post operation
Secondary	Mortality		1 year post operation