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

Study Results

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-09

Study Completion Date

2024-09-16

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Crohn's Disease of Large Intestine Malignant Neoplasm of Colon

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

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 Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Cohort 1: Predetermined points measurement

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

Group Type OTHER

Obtaining bowel gas samples

Intervention Type DEVICE

The Perf-AlertTM prototype 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. It is used in conjunction with a single-use, disposable kit of sterile tubing and filters used for sample collection. 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 surgery, a one-way valve will be opened, and the unit's pump turned on and withdrawing a small amount of gas from the abdominal cavity. The system is configured 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.

Cohort 2: Continuous monitoring

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 Type OTHER

Obtaining bowel gas samples

Intervention Type DEVICE

The Perf-AlertTM prototype 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. It is used in conjunction with a single-use, disposable kit of sterile tubing and filters used for sample collection. 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 surgery, a one-way valve will be opened, and the unit's pump turned on and withdrawing a small amount of gas from the abdominal cavity. The system is configured 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.

Interventions

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Obtaining bowel gas samples

The Perf-AlertTM prototype 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. It is used in conjunction with a single-use, disposable kit of sterile tubing and filters used for sample collection. 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 surgery, a one-way valve will be opened, and the unit's pump turned on and withdrawing a small amount of gas from the abdominal cavity. The system is configured 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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No