Novel device to detect enterotomies in real time during laparoscopy: first in human trial during Roux-en-y gastric bypass
Undetected bowel perforations occur in 0.3–1% of laparoscopic surgical procedures with an associated mortality rate of 5.3%.
The purpose of the study was to evaluate the clinical feasibility of a novel medical device to accurately detect bowel gas, specifically hydrogen (H2) and methane (CH4), from a sample of gas from the abdominal cavity during laparoscopic surgery when a known bowel wall perforation has occurred. Setting: University (Academic) Hospital.
A prospective single arm study was composed of 8 patients undergoing a standard laparoscopic roux-en-y gastric bypass. At seven time points during the operation intra-abdominal gas was pulled from the abdominal cavity and analyzed using the novel device for H2 and CH4. The time points included after insufflation (T1), after first jejunotomy (T2), after closure of jejunotomy (T3), after recycle of carbon dioxide gas (T4), after gastrostomy (T5), after jejunotomy (T6), at procedure end (T7).
Eight patients were enrolled in the study; in 7 (87.5%) patients data from all 7 time points were obtained. After the first opening of the small bowel (T2) mean hydrogen levels were significantly increased compared to baseline hydrogen levels (T1, T4, T7) (p < 0.001). At all time points, there was no significant detection of methane. There were no intra-operative or post-operative complications during the study.
Hydrogen gas is released into the intra-abdominal cavity when bowel is opened and can be detected in real time using a novel device during laparoscopic surgery. The presence or absence of hydrogen directly correlates to whether the bowel is open (perforated) or intact. This device could be used in the future to detect unintended bowel perforations during laparoscopic surgery, prior to the conclusion of the operation. This technology could also potentially lead to novel mechanism for detecting postoperative leaks using gas detection technology.
KeywordsLaparoscopy Bowel injury Bariatric Bowel perforation Bowel gas Injury
The company made the device available at no cost and provided support for its use. No funding was received for this trial.
Compliance with Ethical Standards
Dr. Elisabeth Wynne and Dr. Dan Azagury have no conflicts of interest or financial ties to disclose.
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