Clinical Trial: Evaluation of the Ability to Detect Bowel Gas During Laparoscopic Surgery

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Evaluation of the Ability to Detect Bowel Gas During Laparoscopic Surgery

Brief 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 Summary:

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.

Sponsor: Dan E. Azagury

Current Primary Outcome:

• 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

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Stanford University

Dates:
Date Received: February 4, 2016
Date Started: February 2016
Date Completion:
Last Updated: March 9, 2017
Last Verified: March 2017