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

20 Participants Needed

Trial Summary

What is the purpose of this trial?

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 severe complications, including septic shock and eventually death. The investigator's goal is to test a novel device that can detect bowel gas leakage from perforation and alert the surgeon during the operation by evaluating the gases present in the insufflated abdomen during surgery. This study will determine the ability of the device to be attached to a standard trocar during the operation and periodically draw small samples or aliquots 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, the investigators must first ensure that it can accurately detect bowel gas in an insufflated abdomen.

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 data supports the effectiveness of the Bowel Gas Detection Device, Perf-AlertTM, for laparoscopic colectomy procedures?

The research suggests that analyzing gas in the colon using imaging techniques is a reliable way to assess bowel function after surgery, which may support the use of the Bowel Gas Detection Device in similar contexts. ^{1 2 3 4 5}

How does the Bowel Gas Detection Device treatment differ from other treatments for bowel conditions?

The Bowel Gas Detection Device is unique because it focuses on detecting and analyzing bowel gas during laparoscopic colectomy procedures, which can help assess and manage functional bowel disorders. Unlike other treatments that may focus on symptoms or surgical interventions, this device provides real-time information about gas distribution, potentially improving surgical outcomes and postoperative recovery. ^{1 3 5 6 7}

Research Team

Alessio Pigazzi, MD,PhD

Principal Investigator

Weill Medical College of Cornell University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Relevance of abdominal gas analysis and transit study after colorectal cancer surgery. [2019]

2. Australia pubmed.ncbi.nlm.nih.gov

Real-time bowel sound analysis using newly developed device in patients undergoing gastric surgery for gastric tumor. [2022]

3. England 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. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Validation of an acoustic gastrointestinal surveillance biosensor for postoperative ileus. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Gas volume analysis and postoperative bowel functional disorders in patients who received anterior resection for rectal cancer. [2019]

6. India pubmed.ncbi.nlm.nih.gov

Recording and Analysis of Bowel Sounds. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Quantitative analysis of bowel gas using plain abdominal radiograph in patients with irritable bowel syndrome. [2016]