← Back to Search

Bowel Gas Detection Device for Laparoscopic Colectomy Procedures

N/A

Recruiting

Led By Alessio Pigazzi, MD,PhD

Research Sponsored by Weill Medical College of Cornell University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Documentation of a required elective right laparoscopic hemicolectomy with intracorporeal anastomosis

Be older than 18 years old

Must not have

Patients who are on peritoneal dialysis

Patients undergoing emergency laparotomy for perforated right colon or trauma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up during surgery(from start of laparoscopy to the end of surgical procedure)

Awards & highlights

No Placebo-Only Group

Summary

This trialwill evaluate a device that can detect bowel gas leakage during laparoscopic surgery, which can prevent severe complications and death caused by undetected perforation.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves testing a detection device rather than medication, traditional side effects are not expected. However, there may be minimal risks associated with attaching the device to surgical equipment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am currently undergoing peritoneal dialysis.

Select...

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

Select...

I do not speak English.

Select...

I am under 18 years old.

Select...

I have an abdominal infection, inflammation of the abdomen lining, or an abnormal connection in my intestine.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ during surgery(from start of laparoscopy to the end of surgical procedure)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~during surgery(from start of laparoscopy to the end of surgical procedure)

This trial's timeline: 3 weeks for screening, Varies for treatment, and during surgery(from start of laparoscopy to the end of surgical procedure) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Hydrogen (H2) gas

Methane (CH4) gas

Secondary study objectives

Response time of the Perf-AlertTM device.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Cohort 2: Continuous monitoringExperimental Treatment1 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 measurementExperimental Treatment1 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

0 / 6Eligibility criteria met