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Evaluation of the Ability to Detect Bowel Gas During Laparoscopic Surgery

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ClinicalTrials.gov Identifier: NCT02679118
Recruitment Status : Completed
First Posted : February 10, 2016
Last Update Posted : August 18, 2017
Sponsor:
Information provided by (Responsible Party):
Dan E. Azagury, Stanford University

Brief 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.

Condition or disease Intervention/treatment Phase
Intestinal Perforation Device: Sentire Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Evaluation of the Ability to Detect Bowel Gas During Laparoscopic Surgery
Study Start Date : February 2016
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Arm Intervention/treatment
Experimental: Sentire
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.
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.




Primary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02679118


Locations
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United States, California
Stanford University
Stanford, California, United States, 94305
Sponsors and Collaborators
Dan E. Azagury
Investigators
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Principal Investigator: Dan Azagury, MD Assistant Professor of Surgery
Publications:
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Responsible Party: Dan E. Azagury, Assistant Professor of Surgery, Stanford University
ClinicalTrials.gov Identifier: NCT02679118    
Other Study ID Numbers: IRB-35295
First Posted: February 10, 2016    Key Record Dates
Last Update Posted: August 18, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Dan E. Azagury, Stanford University:
intestinal perforation
bariatric surgery
gastric bypass
gastric perforation
colonic perforation
Additional relevant MeSH terms:
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Intestinal Perforation
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases