Evaluation of the Ability to Detect Bowel Gas During Laparoscopic Surgery

Intestinal Perforation Clinical Trial

Official title:

Evaluation of the Ability to Detect Bowel Gas During Laparoscopic Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02679118
• Other study ID #: IRB-35295
• Status: Completed
• Phase: N/A
• First received: February 4, 2016
• Last updated: August 15, 2017
• Start date: February 2016
• Est. completion date: June 2016

Study information

• Verified date: August 2017
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Intestinal Perforation

Intervention

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.

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Dan E. Azagury

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. Review. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Methane levels released in the abdominal cavity from small bowel	Ability to detect and measure the level of methane released in the abdominal cavity by open small bowel	Intra-operative measurement only
Primary	Hydrogen levels released in the abdominal cavity from small bowel	Ability to detect and measure the level of hydrogen released in the abdominal cavity by open small bowel	Intra-operative measurement only