Detecting bowel gas during laparoscopic surgery
Evaluation of Ability to Detect Bowel Gas During Laparoscopic Right Colectomy With Intracorporeal Anastomosis
This study is testing a new device that helps surgeons spot gas leaks from the bowel during laparoscopic surgery to prevent serious complications.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Weill Medical College of Cornell University Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT04964297 on ClinicalTrials.gov |
What this trial studies
This study evaluates a novel device designed to detect bowel gas leakage during laparoscopic right colectomy with intracorporeal anastomosis. The device, Perf-AlertTM, is attached to a standard trocar and periodically samples gas from the abdominal cavity to identify any gas indicative of bowel perforation. By analyzing the gas composition, the device aims to alert the surgeon in real-time to prevent severe complications from undetected bowel injuries. The study will first confirm the device's ability to accurately detect bowel gas in an insufflated abdomen.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older scheduled for elective right laparoscopic hemicolectomy with intracorporeal anastomosis.
Not a fit: Patients undergoing emergency laparotomy for perforated right colon or trauma, or those with specific abdominal conditions, may not benefit from this study.
Why it matters
Potential benefit: If successful, this device could significantly reduce the risk of severe complications from undetected bowel perforations during laparoscopic surgeries.
How similar studies have performed: While the approach of using gas detection in surgery is innovative, similar studies have not been widely reported, making this a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male or female ≥ 18 years of age. * Documentation of a required elective right laparoscopic hemicolectomy with intracorporeal anastomosis * Subject signed inform consent Exclusion Criteria: * Less than 18 years old * Pregnant or breastfeeding patients * Patients undergoing emergency laparotomy for perforated right colon or trauma * Patients with Intraabdominal abscess, peritonitis, or enteric fistula * Patients who are on peritoneal dialysis * Subjects do not speak English
Where this trial is running
New York, New York
- Weill Cornell Medicine — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Alessio Pigazzi, MD,PhD — Weill Medical College of Cornell University
- Study coordinator: Rohit Rasane
- Email: rkr4004@med.cornell.edu
- Phone: 646-962-2789
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.