Clinical Trials Logo

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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02679118
Study type Interventional
Source Stanford University
Contact
Status Completed
Phase N/A
Start date February 2016
Completion date June 2016

See also
  Status Clinical Trial Phase
Completed NCT04180735 - Intestinal Perforation in Patients Receiving an Orthtopic Liver Transplantation in the Montpellier University Hospital
Completed NCT03997721 - Pathophysiology of Perioperative Fluid Management in Emergency Laparotomy
Completed NCT01223261 - Observational Study of Surgical Treatment of Necrotizing Enterocolotis
Completed NCT04020939 - The Role of Indocyanine Green Angiography Fluorescence on Intestinal Resections in Pediatric Surgery. N/A
Recruiting NCT05293353 - Neokare Safety and Tolerability Assessment in Neonates With GI Problems
Completed NCT01029353 - Laparotomy vs. Drainage for Infants With Necrotizing Enterocolitis N/A
Completed NCT01958320 - Early Treatment Versus Delayed Conservative Treatment of the Patent Ductus Arteriosus Phase 2
Terminated NCT01110382 - A Safety and Tolerability Study of Doripenem Compared With Meropenem in Children Hospitalized With Complicated Intra-abdominal Infections Phase 3
Recruiting NCT05208489 - Direct Peritoneal Resuscitation for Intra-abdominal Catastrophes
Recruiting NCT05562102 - TyVECO: Surveillance Protocol
Not yet recruiting NCT05734118 - Safety and Feasibility of Indocyanine Green Fluorescence for Intraoperative Assessment of Intestinal Perfusion in Young Infants and Neonates N/A
Recruiting NCT01530828 - IRT in Infants With Intestinal Perforation N/A