Evaluation of the Ability to Detect Bowel Gas During Laparoscopic Surgery



Status:Completed
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:3/11/2017
Start Date:February 2016
End Date:June 2016

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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.

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.

Inclusion Criteria:

1. Age 18 - 60 years old with the diagnosis of morbid obesity, who qualifies for
laparoscopic gastric bypass surgical therapy, and has elected to undergo laparoscopic
gastric bypass surgery.

2. Receiving care in the Stanford Hospital General Surgery Bariatric Surgery Clinic
under the care of Dr. Dan Azagury

3. The patient is scheduled for laparoscopic roux en y gastric bypass surgery, with Dr.
Azagury.

4. Willing and cognitively able to sign informed consent.

Exclusion Criteria:

1. Lack of or inability to provide informed consent.

2. Less than 18 years of age or greater than 60 years of age

3. Planned deviation from the standard laparoscopic gastric bypass operation

4. Conversion intra-operatively from a laparoscopic gastric bypass to an alternative
laparoscopic surgical operation or to an open gastric bypass operation.

5. Enrollment in another device or drug study that may confound results.
We found this trial at
1
site
450 Serra Mall
Stanford, California 94305
(650) 723-2300
Phone: 650-736-9800
Stanford University Stanford University, located between San Francisco and San Jose in the heart of...
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from
Stanford, CA
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