Assessing Infectious Risk and Visceral Closure in Natural Orifice Translumenal Endoscopic Surgery (NOTES)

Completed

Conditions studied: Colonic Diseases, Rectal Diseases

In brief

The purpose of this study is to determine: 1. What quantity of bacteria is spilled into the abdomen during a colon resection 2. If there is a correlation between the quantity and post-operative infection 3. What intralumenal pressure is generated when testing the colonic anastomosis for air leak

Key facts

Study ID

NCT01102725

Run by

University Hospitals Cleveland Medical Center

People needed

12

Starts

2010-04-01

Expected to finish

2011-06-01

Last updated by the study team

2014-12-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Male and Female patients ≥18 years of age
• Subjects have a known preexisting condition that has been deemed treatable by totally laparoscopic or hand-assisted laparoscopic colorectal resection
• Any colon or rectal resection where ileocolonic, ileorectal, colocolonic, or colorectal anastomoses is created in the pelvis requiring a leak test. Air-leak test can be performed by an instrument of the surgeons discretion, such as a colonoscope, sigmoidoscope (rigid or flexible), or bulb syringe.

You may not qualify if…

• Surgical resection performed in an emergency setting
• Patients undergoing resection in a known contaminated field (i.e. entero-/colo-cutaneous fistula or acute diverticulitis) as this will bias the bacterial cultures collected intraoperatively

Where it is running

• University Hospitals Case Medical Center — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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