Clinical trial NCT02679118: Evaluation of the Ability to Detect Bowel Gas During Laparoscopic Surgery
Official title: Evaluation of the Ability to Detect Bowel Gas During Laparoscopic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intestinal Perforation
Keywords: intestinal perforation
bariatric surgery
gastric bypass
gastric perforation
colonic perforation
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2016-02-10
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Methane levels released in the abdominal cavity from small bowel
timeFrame: Intra-operative measurement only
measure: Hydrogen levels released in the abdominal cavity from small bowel
timeFrame: Intra-operative measurement only
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Assistant Professor of Surgery
name: Dan Azagury, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Deffieux X, Ballester M, Collinet P, Fauconnier A, Pierre F; French National College of Gynaecologists and Obstetricians. Risks associated with laparoscopic entry: guidelines for clinical practice from the French College of Gynaecologists and Obstetricians. Eur J Obstet Gynecol Reprod Biol. 2011 Oct;158(2):159-66. doi: 10.1016/j.ejogrb.2011.04.047. Epub 2011 May 31.
citation: Sahakian AB, Jee SR, Pimentel M. Methane and the gastrointestinal tract. Dig Dis Sci. 2010 Aug;55(8):2135-43. doi: 10.1007/s10620-009-1012-0. Epub 2009 Oct 15.
citation: van der Voort M, Heijnsdijk EA, Gouma DJ. Bowel injury as a complication of laparoscopy. Br J Surg. 2004 Oct;91(10):1253-8. doi: 10.1002/bjs.4716.