Colon Cancer Clinical Trial

Evaluation of Ability to Detect Bowel Gas During Laparoscopic Right Colectomy With Intracorporeal Anastomosis

Summary

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.

View Full Description

Full Description

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 gases present in the insufflated abdomen during surgery. During laparoscopic surgery, CO2 is inserted into the abdominal cavity in order to perform the operation. This is a dynamic process as insufflation is constant during the entire procedure to maintain constant pressure and compensate for any small leaks due to the insertion and retrieval of instruments.

This study will determine the ability of a novel device to be attached to a standard 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 the investigators must ensure that it can accurately detect bowel gas in an insufflated abdomen.

The Investigational device, Perf-AlertTM, consists of a 15" x 13" x 7" unit containing gas sensors and valves, a small box containing a one way, ultra-low pressure pump, user controls (buttons), and software algorithms, which control the operation of the device ( Image1). It is used in conjunction with a single-use, disposable kit consisting of sterile tubing and filters used for sample collection and transport (Image 2). The sensing unit will be connected via a sterile tube/filter set to any trocar port in use during the procedure. At specific time points during the procedure, a one-way valve will be opened and the unit's pump turned on pulling small aliquots of gas from the abdominal cavity to the sensing unit. The system's architecture is configured such that sample collection, transport, analysis, and feedback occur in a single step such that sample collection and sensor feedback occur in real-time. A standard laptop running an analytical software program is connected to the unit to record and log sensor readings. No changes to the device are anticipated during the course of the study.

View Eligibility Criteria

Eligibility 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

Study is for people with:

Colon Cancer

Estimated Enrollment:

20

Study ID:

NCT04964297

Recruitment Status:

Recruiting

Sponsor:

Weill Medical College of Cornell University

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There is 1 Location for this study

See Locations Near You

Weill Cornell Medicine
New York New York, 10065, United States More Info
Jujhar Singh
Contact
646-962-2789
[email protected]
Julianna Brouwer
Contact
646 9622394
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Colon Cancer

Estimated Enrollment:

20

Study ID:

NCT04964297

Recruitment Status:

Recruiting

Sponsor:


Weill Medical College of Cornell University

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.