Bowel Gas Detection Device for Laparoscopic Colectomy Procedures

Overseen By Ananya Sen

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Weill Medical College of Cornell University

Disqualifiers: Pregnant, Peritoneal dialysis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device, the Bowel Gas Detection Device (Perf-AlertTM), which helps surgeons detect bowel perforations (tears in the bowel) during laparoscopic surgery. Early detection of these perforations is crucial because missed cases can lead to serious health issues. The device checks the gases in the abdomen during surgery to identify signs of a perforation. Individuals needing an elective right laparoscopic hemicolectomy (a planned surgery to remove part of the colon) might be suitable for this trial. As an unphased trial, this study allows patients to contribute to innovative surgical advancements and improve future outcomes.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this bowel gas detection device is safe for laparoscopic colectomy procedures?

Research shows that the Bowel Gas Detection Device is undergoing tests to determine its ability to identify gas leaks in the bowel during surgery. This device alerts surgeons to leaks, potentially preventing serious complications.

Currently, specific safety information for this device is unavailable. It remains in an early testing phase, focusing on functionality rather than safety details. More comprehensive safety information typically emerges in later testing phases.

Prospective trial participants should understand that while the device aims to detect issues during surgery, its safety is still under study. This is standard for new medical devices, and understanding the potential risks and benefits is crucial when deciding whether to participate. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Bowel Gas Detection Device because it offers a novel approach to laparoscopic colectomy procedures. Unlike traditional methods that rely heavily on visual cues and surgeon experience, this device aims to provide real-time data on bowel gas levels. This could enhance surgical precision and potentially reduce complications by allowing for better management of bowel distension. The trial is exploring two distinct methods: predetermined points measurement and continuous monitoring, each contributing unique insights into the dynamics of bowel gases during surgery. By potentially improving surgical outcomes and patient safety, this technology represents a significant advancement in laparoscopic techniques.

What evidence suggests that this device is effective for detecting bowel gas during laparoscopic colectomy procedures?

Research shows that the Bowel Gas Detection Device, Perf-AlertTM, could help detect bowel gas leaks during laparoscopic colectomy surgeries. This trial will evaluate the device's effectiveness in two separate cohorts. Cohort 1 will measure bowel gas at 8 predetermined time points during surgery, while Cohort 2 will continuously monitor bowel gases throughout the procedure. Initial results suggest that the device accurately detects gases like hydrogen and methane released from the bowel. Quickly finding bowel tears is crucial to prevent serious issues like septic shock. Although more research is needed to fully confirm its effectiveness, the device's potential to improve surgery outcomes is promising. ^{1 2 3 6 7}

Who Is on the Research Team?

Mehraneh Jafari, MD

Principal Investigator

Weill Medical College of Cornell University

Are You a Good Fit for This Trial?

This trial is for adults over 18 who need elective laparoscopic right colectomy with intracorporeal anastomosis and can give informed consent. It's not for non-English speakers, emergency cases, peritoneal dialysis patients, those with abdominal infections or fistulas, or pregnant/breastfeeding individuals.

Inclusion Criteria

Subject signed inform consent

I am scheduled for a specific surgery on the right side of my colon.

Exclusion Criteria

I am currently undergoing peritoneal dialysis.

I am having emergency surgery for a ruptured right colon or injury.

I am under 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgical Procedure

Participants undergo laparoscopic right colectomy with intracorporeal anastomosis while the novel device is tested for detecting bowel gas leakage.

During surgery

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the surgical procedure.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Bowel Gas Detection Device

Trial Overview The study tests a new device designed to detect bowel gas from perforations during laparoscopic surgery by sampling gases in the abdomen. The goal is to ensure it accurately identifies bowel gas without interrupting the procedure.

How Is the Trial Designed?

Group I: Cohort 2: Continuous monitoring Experimental Treatment 1 Intervention

Cohort 2: Continuous monitoring: 10 subjects with continuous monitoring of bowel gases through the surgery. The level of H2 and CH4 gases will be noted at the 8 predetermined time points during the continuous monitoring as well.

Group II: Cohort 1: Predetermined points measurement Experimental Treatment 1 Intervention

Cohort 1: Predetermined points measurement: 10 subjects with measurement of bowel gas at 8 predetermined time points during right laparoscopic colectomy as follow: 1. Initiation of surgery/laparoscopy start Insufflation 2. Abdominal exploration 3. Completion of colon mobilization 4. Colon transection 5. At Colotomy 6. At Enterotomy 7. Anastomosis completion 8. End of surgery- after re-insufflation before closure

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

Sentire Medical Systems

Collaborator

Trials

1

Recruited

20+

Published Research Related to This Trial

A new stool analysis method using headspace gas chromatography and a metal oxide sensor can differentiate between inflammatory bowel disease (IBD) and irritable bowel syndrome (IBS) with a sensitivity of 76% and specificity of 88%.

This non-invasive testing approach shows promise for accurately diagnosing these two distinct gastrointestinal diseases, achieving an overall predictive accuracy of 76% based on patient samples.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of a gas chromatograph coupled to a metal oxide sensor for rapid assessment of stool samples from irritable bowel syndrome and inflammatory bowel disease patients. Shepherd, SF., McGuire, ND., de Lacy Costello, BP., et al.[2023]

In a study of 50 patients who underwent low anterior resections for rectal cancer, those who experienced constipation and required laxatives had significantly higher colon gas volumes in the left colon compared to those who did not use laxatives.

Patients reporting feelings of incomplete evacuation also showed higher left colon gas scores, suggesting that increased gas volume in this area may be linked to postoperative bowel disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gas volume analysis and postoperative bowel functional disorders in patients who received anterior resection for rectal cancer. Seike, K., Koda, K., Takiguchi, N., et al.[2019]

In a study of 40 rectosigmoid cancer patients post-surgery, colon gas volume analysis was found to be a useful method for evaluating colonic transit time, with specific transit times recorded for the right and left colon.

The study revealed a significant correlation between the ratio of left colon transit time to right colon transit time and the ratio of left colon gas volume to right colon gas volume, suggesting that gas volume analysis can provide insights into bowel function after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relevance of abdominal gas analysis and transit study after colorectal cancer surgery. Seike, K., Koda, K., Oda, K., et al.[2019]

A novel real-time bowel sound monitoring system was evaluated in 14 patients undergoing gastric surgery, showing a significant increase in bowel sounds postoperatively (2.5 counts per minute) compared to preoperative levels (1.4 counts per minute).

The study found a significant negative correlation between postoperative bowel sound count and operation time, suggesting that shorter surgical durations may enhance recovery of bowel function, supporting the benefits of minimally invasive surgical techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-time bowel sound analysis using newly developed device in patients undergoing gastric surgery for gastric tumor. Namikawa, T., Yamaguchi, S., Fujisawa, K., et al.[2022]

The study developed an electronic bowel sound recording system that effectively differentiates between bowel sounds in patients with appendicitis, mechanical ileus, and diffuse peritonitis, using a sample of 67 subjects.

Significant differences in the number of bowel sounds were found among the groups, with mechanical ileus and diffuse peritonitis showing notably fewer sounds compared to controls, indicating that specific bowel sound patterns could aid in diagnosing these acute abdominal conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recording and Analysis of Bowel Sounds. Zaborski, D., Halczak, M., Grzesiak, W., et al.[2022]

In a study involving 30 IBS patients and 30 normal controls, the quantity of bowel gas was significantly higher in IBS patients, suggesting a potential link between bowel gas volume and IBS diagnosis.

The study introduced a gas volume score (GVS) as a reliable and objective measure for diagnosing IBS, showing consistent results across repeated radiographs, although no direct correlation was found between bowel gas volume and colonic transit time or IBS symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quantitative analysis of bowel gas using plain abdominal radiograph in patients with irritable bowel syndrome. Koide, A., Yamaguchi, T., Odaka, T., et al.[2016]

The AGIS biosensor effectively distinguishes between healthy individuals and patients with postoperative ileus (POI), achieving 100% sensitivity and 97% specificity in identifying POI cases among 40 subjects, including 8 healthy controls and 25 with POI.

Patients who were able to tolerate feeding showed significantly higher intestinal acoustic event rates compared to those with POI, suggesting that AGIS could help guide postoperative feeding decisions and improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of an acoustic gastrointestinal surveillance biosensor for postoperative ileus. Spiegel, BM., Kaneshiro, M., Russell, MM., et al.[2021]

Citations

1. withpower.com withpower.com/trial/phase-neoplasms-7-2021-68610

Bowel Gas Detection Device for Laparoscopic Colectomy ... What data supports the effectiveness of the Bowel Gas Detection Device, Perf-AlertTM, for laparoscopic colectomy procedures? The research suggests that ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04964297

NCT04964297 | Evaluation of Ability to Detect Bowel Gas ... The goal of this study is to test a novel device that can detect bowel gas leakage from perforation and alert the surgeon during the operation by evaluating the ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02679118

Evaluation of the Ability to Detect Bowel Gas During ... 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 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10416696/

Intraoperative bowel perfusion assessment methods and ... Outcomes. The primary outcome was the incidence of anastomotic leak within 30 days of major colorectal surgery involving intraoperative use of ...

5. nature.com nature.com/articles/s41598-022-04822-x

Non-invasive laparoscopic detection of small tumors of the ... A new instrument adapted to minimally-invasive surgery, and manipulated solely by the operating surgeon which has the potential to locate precisely tumors of ...

6. researchgate.net researchgate.net/publication/330711921_Novel_device_to_detect_enterotomies_in_real_time_during_laparoscopy_first_in_human_trial_during_Roux-en-y_gastric_bypass

Novel device to detect enterotomies in real time during ... Background Undetected bowel perforations occur in 0.3–1% of laparoscopic surgical procedures with an associated mortality rate of 5.3%.

7. mdpi.com mdpi.com/2072-6694/16/13/2303

Wearable Devices in Colorectal Surgery: A Scoping Review This research explores how wearable devices can be used to monitor patients undergoing colorectal surgery.