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Evaluation of the Ability to Detect Bowel Gas During Laparoscopic Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE February 4, 2016
First Posted Date  ICMJE February 10, 2016
Last Update Posted Date August 18, 2017
Study Start Date  ICMJE February 2016
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 5, 2016)
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of the Ability to Detect Bowel Gas During Laparoscopic Surgery
Official Title  ICMJE Evaluation of the Ability to Detect Bowel Gas During Laparoscopic Surgery
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Condition  ICMJE Intestinal Perforation
Intervention  ICMJE 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.
Study Arms  ICMJE 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.
Intervention: Device: Sentire
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 9, 2017)
8
Original Estimated Enrollment  ICMJE
 (submitted: February 5, 2016)
10
Actual Study Completion Date  ICMJE June 2016
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02679118
Other Study ID Numbers  ICMJE IRB-35295
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Dan E. Azagury, Stanford University
Study Sponsor  ICMJE Dan E. Azagury
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dan Azagury, MD Assistant Professor of Surgery
PRS Account Stanford University
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP