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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sentire | Experimental | The patients will undergo their laparoscopic gastric bypass, during the operative period at pre-defined time points, a small amount of gas from the abdomen will be withdrawn and analyzed for the device. The laparoscopic gastric bypass will proceed without interference or effect from the device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sentire | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dan Azagury, MD | Assistant Professor of Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Stanford | California | 94305 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21621318 | Background | 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. | |
| 19830557 |
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| ID | Term |
|---|---|
| D007416 | Intestinal Perforation |
| ID | Term |
|---|---|
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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|
| 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. |
| 15376204 | Background | 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. |