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Rectal Diseases clinical trials

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NCT ID: NCT01312246 Withdrawn - Clinical trials for Colon and Rectal Diseases

EnSeal Efficacy and Bursting Pressure in Human Vessels

Start date: April 2011
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT01102725 Completed - Colonic Diseases Clinical Trials

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

NOTES
Start date: April 2010
Phase: N/A
Study type: Observational

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

NCT ID: NCT01037049 Active, not recruiting - Neoplasms Clinical Trials

Optimum Timing for Surgery After Pre-operative Radiotherapy 6 vs 12 Weeks

Start date: October 16, 2009
Phase: Phase 2
Study type: Interventional

The aim of this study is to determine whether greater rectal cancer downstaging and regression occurs when surgery is delayed to 12 weeks after completion of radiotherapy/chemotherapy compared to 6 weeks. Hypothesis: Greater downstaging and tumour regression is observed when surgery is delayed to 12 weeks after completion of CRT compared to 6 weeks.

NCT ID: NCT00487409 Completed - Colonic Diseases Clinical Trials

Random Comparison of LigaSure and Disposable Staples for Laparoscopic Surgery

Start date: December 2006
Phase: N/A
Study type: Interventional

The purpose of this research is to compare two different standard of care surgical methods for the following large bowel (colon) procedures: laparoscopic right colectomy, total colectomy, and left colectomy. The study will compare electrocautery, used with surgical clips and/or surgical staplers, and the Ligasure vessel sealer. The investigators will be looking at which procedure is faster and more cost efficient and the investigators will calculate hospital expenses for the two groups to make comparisons.