Evaluation of the Ability to Detect Bowel Gas During Laparoscopic Surgery
|ClinicalTrials.gov Identifier: NCT02679118|
Recruitment Status : Completed
First Posted : February 10, 2016
Last Update Posted : August 18, 2017
|Condition or disease||Intervention/treatment||Phase|
|Intestinal Perforation||Device: Sentire||Not Applicable|
Undetected bowel perforation is a rare but dangerous complication of laparoscopic surgery. If the injury is not detected and treated at the time of the surgical procedure, the patient can suffer sever complications including septic shock and eventually death. Our goal is to test a novel device that can detect bowel gas leakage from a perforation and alert the surgeon during the operation by evaluating the gases present in the insufflated abdomen during surgery. During laparoscopic surgery, carbon dioxide in inserted in the abdominal cavity in order to perform the operation. This is dynamic process as insufflation is a constant during the entire procedure to maintain a constant pressure and compensate small leaks due to the insertion and retrieval of instruments.
This study will determine the ability of device to be attached to a standard Veress needle or trocar during the operation and periodically draw a small amount of gas from the abdomen to evaluate the gas and accurately detect gaseous content from the bowel. Before the device can be used to detect bowel perforations, first we must ensure that it can accurately detect bowel gas in an insufflated abdomen.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Device Feasibility|
|Official Title:||Evaluation of the Ability to Detect Bowel Gas During Laparoscopic Surgery|
|Study Start Date :||February 2016|
|Actual Primary Completion Date :||June 2016|
|Actual Study Completion Date :||June 2016|
The patients will undergo their laparoscopic gastric bypass, during the operative period at pre-defined time points, a small amount of gas from the abdomen will be withdrawn and analyzed for the device. The laparoscopic gastric bypass will proceed without interference or effect from the device.
The device, at predetermined time points, will draw a small amount of gas from the abdomen. Upon obtaining the samples, the machine will analyze the sample for evidence of bowel gas. After each sample, the device will be purged prior to the acquisition of the next gas sample. The results of the analysis of the gas samples will be recorded for future analysis.
- Methane levels released in the abdominal cavity from small bowel [ Time Frame: Intra-operative measurement only ]Ability to detect and measure the level of methane released in the abdominal cavity by open small bowel
- Hydrogen levels released in the abdominal cavity from small bowel [ Time Frame: Intra-operative measurement only ]Ability to detect and measure the level of hydrogen released in the abdominal cavity by open small bowel
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02679118
|United States, California|
|Stanford, California, United States, 94305|
|Principal Investigator:||Dan Azagury, MD||Assistant Professor of Surgery|