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Completed

NCT Number: NCT02679118

Evaluation of the Ability to Detect Bowel Gas During Laparoscopic Surgery

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University

Stanford, California, 94305, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Receiving care in the Stanford Hospital General Surgery Bariatric Surgery Clinic under the care of Dr. Dan Azagury
  • The patient is scheduled for laparoscopic roux en y gastric bypass surgery, with Dr. Azagury.
  • Willing and cognitively able to sign informed consent.

Exclusion criteria

  • Lack of or inability to provide informed consent.
  • Less than 18 years of age or greater than 60 years of age
  • Planned deviation from the standard laparoscopic gastric bypass operation
  • Conversion intra-operatively from a laparoscopic gastric bypass to an alternative laparoscopic surgical operation or to an open gastric bypass operation.
  • Enrollment in another device or drug study that may confound results.

Treatment and study plan

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.

Primary outcomes

  1. Methane levels released in the abdominal cavity from small bowel

    Time frame: Intra-operative measurement only

    Ability to detect and measure the level of methane released in the abdominal cavity by open small bowel

  2. Hydrogen levels released in the abdominal cavity from small bowel

    Time frame: Intra-operative measurement only

    Ability to detect and measure the level of hydrogen released in the abdominal cavity by open small bowel

Sponsors and collaborators

Lead sponsor

Dan E. Azagury

Other

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Feb 10, 2016
Registry last updated
Aug 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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