In this study the investigators will include adult patients who are not part of a vulnerable
patient population. Inclusion criteria include patients who will be undergoing resection of
part of their colon that will require dividing the IMA. The investigators will use the
resected surgical specimens for our project. The investigators will use the EnSeal on all
major vessels in our procedure. The investigators will use the EnSeal 5 mm round head model.
Due to the nature of the project, we will apply for IRB approval prior to beginning our
research. The investigators plan to include 60 total patients in the study, 30 at the
University of Illinois and 30 at Lutheran General Hospital.
Prior to resection, the investigators will use a sterile caliper to take an in-vivo
measurement of the IMA and IMV. Immediately after resection, the investigators will remove
the sealed proximal end of the IMA and the 3 cm distal to it from the surgical specimen. The
investigators will similarly prepare the IMV. The investigators will inspect our vessels for
any iatrogenic traumatic tears. If the vessels are suitable, the investigators will then
gentle apply manual traction to remove any blood or clots within the lumen. The investigators
will measure the outer diameter of the vessels using a digital caliper. If there are small
branches, the investigators will tie them off with suture. The unsealed end will then be
attached to the burst pressure tester with suture and it will be tested for the bursting
pressure. The device measures pressure continuously as it infuses the segment with normal
saline at a steady rate (50 ml/hr). A leak will be determined by a decrease in intra-luminal
pressure of 100 mm Hg or a visible leak. A failure to seal the vessels will be determined by
a bursting pressure of less than 100 mm Hg. It should be noted that each section would only
be pressure-tested once. All of our data will be collected on the enclosed data sheet we have
created for use in this protocol. The investigators will then place the vessels with the
original surgical specimen where it will be submitted for routine pathological examination of
surgical specimens. Twenty five specimens at each site will undergo the testing, whereas 5
specimens will be sent to pathology without testing.
Our pathologist will analyze the submitted specimen for extent of seal, disruption of vessel
smooth muscle, gas bubbles, and will stain for elastin to analyze the disruption in the
vessel wall. In addition, the seal will be measured and we will obtain digital images. The
specimens submitted for pathology will be 5 burst specimens as well as 5 un-burst specimens
taken from the pool of 25 patients at UIC.
For our human component, the investigators have estimated the standard deviation and width of
the confidence interval to be 100 mm Hg each. With a 95% confidence level, the investigators
expect to require 16 measurements for human specimens from 16 patients although the
investigators will use 50 patients to allow for errors in obtaining pressures.
Our timeline for the completion of the projects is 6 months. The investigators plan on being
able to complete the human burst pressure testing within 6 months.