NCT02679118

Evaluation of the Ability to Detect Bowel Gas During Laparoscopic Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Dan E. Azagury · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will determine the ability of the device to draw a small amount of gas from an insufflated abdomen during laparoscopic surgery and accurately detect if gaseous content from the bowel is present.

Detailed description

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.

Conditions

• Intestinal Perforation

Interventions

Type	Name	Description
DEVICE	Sentire	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.

Timeline

• Start date: 2016-02-01
• Primary completion: 2016-06-01
• Completion: 2016-06-01
• First posted: 2016-02-10
• Last updated: 2017-08-18

Locations

1 site across 1 country: United States