Intestinal PerforationNCT02679118
Evaluation of the Ability to Detect Bowel Gas During Laparoscopic Surgery
A study testing Sentire in people with Intestinal Perforation, run by Dan E. Azagury at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intestinal Perforation
- What is being tested?
- Sentire
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Intestinal Perforation
- Being tested
- Sentire
- Keywords
- intestinal perforation, bariatric surgery, gastric bypass, gastric perforation, colonic perforation
- Medical subject headings
- Intestinal Perforation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SentireDevice
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 group | Role | What they receive |
|---|---|---|
| Sentire | Experimental | 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. Receives: Device: Sentire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Methane levels released in the abdominal cavity from small bowel
Ability to detect and measure the level of methane released in the abdominal cavity by open small bowel
Measured: Intra-operative measurement only
Hydrogen levels released in the abdominal cavity from small bowel
Ability to detect and measure the level of hydrogen released in the abdominal cavity by open small bowel
Measured: Intra-operative measurement only
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Intestinal PerforationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dan E. Azagury
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dan E. Azagury, Stanford University
- Investigators
- Dan Azagury, MD, Principal investigator, Assistant Professor of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02679118
- Sponsor's protocol ID
- IRB-35295
- Status last verified
- Aug 2017
- First submitted
- 4 Feb 2016
- Last updated
- 18 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Deffieux X, Ballester M, Collinet P, Fauconnier A, Pierre F; French National College of Gynaecologists and Obstetricians. Risks associated with laparoscopic entry: guidelines for clinical practice from the French College of Gynaecologists and Obstetricians. Eur J Obstet Gynecol Reprod Biol. 2011 Oct;158(2):159-66. doi: 10.1016/j.ejogrb.2011.04.047. Epub 2011 May 31.
PubMed 21621318Sahakian AB, Jee SR, Pimentel M. Methane and the gastrointestinal tract. Dig Dis Sci. 2010 Aug;55(8):2135-43. doi: 10.1007/s10620-009-1012-0. Epub 2009 Oct 15.
PubMed 19830557van der Voort M, Heijnsdijk EA, Gouma DJ. Bowel injury as a complication of laparoscopy. Br J Surg. 2004 Oct;91(10):1253-8. doi: 10.1002/bjs.4716.
PubMed 15376204
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Ability to Detect Bowel Gas During Laparoscopic Surgery
- ClinicalTrials.gov ID
- NCT02679118
- Acronym / sponsor ID
- IRB-35295
- Conditions
- Intestinal Perforation
- Keywords
- intestinal perforation, bariatric surgery, gastric bypass, gastric perforation, colonic perforation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Dan E. AzaguryUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 10 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sentire | Experimental | Device: SentireThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SentireThe 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. | Device | Sentire |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2017.
- Background: PubMed 21621318Deffieux X, Ballester M, Collinet P, Fauconnier A, Pierre F; French National College of Gynaecologists and Obstetricians. Risks associated with laparoscopic entry: guidelines for clinical practice from the French College of Gynaecologists and Obstetricians. Eur J Obstet Gynecol Reprod Biol. 2011 Oct;158(2):159-66. doi: 10.1016/j.ejogrb.2011.04.047. Epub 2011 May 31.
- Background: PubMed 19830557Sahakian AB, Jee SR, Pimentel M. Methane and the gastrointestinal tract. Dig Dis Sci. 2010 Aug;55(8):2135-43. doi: 10.1007/s10620-009-1012-0. Epub 2009 Oct 15.
- Background: PubMed 15376204van der Voort M, Heijnsdijk EA, Gouma DJ. Bowel injury as a complication of laparoscopy. Br J Surg. 2004 Oct;91(10):1253-8. doi: 10.1002/bjs.4716.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dan Azagury, MD principal investigator
Assistant Professor of Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sentire in people with Intestinal Perforation, run by Dan E. Azagury at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Methane levels released in the abdominal cavity from small bowel (time frame: Intra-operative measurement only). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02679118, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2017.