Clinical trial NCT04964297: Evaluation of Ability to Detect Bowel Gas During Laparoscopic Right Colectomy With Intracorporeal Anastomosis
Official title: Evaluation of Ability to Detect Bowel Gas During Laparoscopic Right Colectomy With Intracorporeal Anastomosis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Crohn's Disease of Large Intestine
Malignant Neoplasm of Colon
Keywords: Colon cancer, Crohn's disease, Perf-AlertTM device, Hydrogen gas(H2), gas Methane (CH4)
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: Sentire Medical Systems
First posted: 2021-07-16
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Prospective pilot, single-center, single-arm, open-label, phase 1 investigator-initiated study to determine device ability to detect bowel gas during laparoscopic right colectomy with intracorporeal anastomosis using Perf-AlertTM gas detection system on 20 subjects into 2 Cohorts.

Cohort 1: 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

Cohort 2: 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.
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed 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.

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

Primary outcomes:
measure: Methane (CH4) Gas
timeFrame: during surgery(from start of laparoscopy to the end of surgical procedure)
measure: Hydrogen (H2) Gas
timeFrame: during surgery(from start of laparoscopy to the end of surgical procedure)
Secondary outcomes:
measure: Response Time of the Perf-AlertTM Device.
timeFrame: during surgery(from start of laparoscopy to the end of surgical procedure)
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Mehraneh Jafari, MD
role: PRINCIPAL_INVESTIGATOR
References: