Assessing Infectious Risk and Visceral Closure in Natural Orifice Translumenal Endoscopic Surgery (NOTES) (NOTES)
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|ClinicalTrials.gov Identifier: NCT01102725|
Recruitment Status : Completed
First Posted : April 13, 2010
Last Update Posted : December 16, 2014
The purpose of this study is to determine:
- What quantity of bacteria is spilled into the abdomen during a colon resection
- If there is a correlation between the quantity and post-operative infection
- What intralumenal pressure is generated when testing the colonic anastomosis for air leak
|Condition or disease|
|Colonic Diseases Rectal Diseases|
The acceptance and advancement of natural orifice translumenal endoscopic surgery (NOTES) has forced investigators to challenge many firmly accepted surgical practices. The most obvious one being: violating a remote hollow viscous that is uninvolved in the desired surgical intervention. This of course brings into question (1) "How much peritoneal contamination can be tolerated without raising infection risk?" and (2) "How will one repair this intended visceral injury?" This study is intended to bring to light what has been done in animal models, and further, how it will translate in to the now more important human arena.
In this study, patients who are undergoing an elective colectomy will be investigated to quantify what amount of peritoneal contamination is tolerated despite rare abscess formation occurring. Subject will undergo peritoneal washings before and after colonic resection to measure the bacterial load spilled. This data would be beneficial to support that patients who are undergoing a NOTES procedure can and will be able to tolerate a definite quantity of bacterial contaminate. Furthermore, by observing the exact values of peritoneal contamination present there may be a certain level to which infectious complication are more likely to occur. This may provide some insight in NOTES as to when patients may benefit post-operatively from a prophylactic course of antibiotic therapy in response to their higher than tolerable intra-peritoneal bacterial load.
The other component to this study will be to challenge how investigators are examining closure devices in the animal model. Many researchers, including authors of this protocol, have utilized bursting pressure as an objective test to assess the integrity of a completed closure. Current surgical practice uses the insufflation of an endoscope or even a bulb syringe to test for leak of a colonic anastomosis. We intend to measure the pressures that are achieved in a clinical setting to determine the bursting pressures that are required to assess NOTES closure and eliminate the likely unsupported value being placed on a higher bursting pressure commonly quoted in NOTES closure studies.
|Study Type :||Observational|
|Actual Enrollment :||12 participants|
|Official Title:||The Challenge of Assessing Infectious Risk and Visceral Closure in NOTES: A Prospective Study Examining Routine Colorectal Surgery as a Model in Humans|
|Study Start Date :||April 2010|
|Actual Primary Completion Date :||June 2011|
|Actual Study Completion Date :||June 2011|
Subject who are undergoing a colon or rectal resection
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01102725
|United States, Ohio|
|University Hospitals Case Medical Center|
|Cleveland, Ohio, United States, 44106|
|Principal Investigator:||Jeffrey M. Marks, MD||University Hospitals Cleveland Medical Center|