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

NCT04964297 | Terminated Results FDA Device

• 1 other identifier: 20-10022823
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

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)

Outcome Measures

Primary Outcomes (2)

• Methane (CH4) Gas

  Methane (CH4) gas measured in ppm or mg/L (parts per million or milligrams per liter (mg/L) at 8-time points

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

• Hydrogen (H2) Gas

  Hydrogen (H2) gas measured in ppm or mg/L (parts per million or milligrams per liter (mg/L) at 8-time points

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

Secondary Outcomes (1)

• Response Time of the Perf-AlertTM Device.

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

Study Arms (2)

Cohort 1: Predetermined points measurement

OTHER

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

Device: Obtaining bowel gas samples

Cohort 2: Continuous monitoring

OTHER

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.

Device: Obtaining bowel gas samples

Interventions

Obtaining bowel gas samples 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 1: Predetermined points measurement; Cohort 2: Continuous monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female ≥ 18 years of age.
• Documentation of a required elective right laparoscopic hemicolectomy with intracorporeal anastomosis
• Subject signed inform consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• Sentire Medical Systems: collaborator

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Crohn Disease; Colonic Neoplasms

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Colonic Diseases

Limitations and Caveats

This study was terminated leading to small numbers of subjects enrolled and analyzed.

Results Point of Contact

• Title: Dr. Mehraneh Jafari
• Organization: Weill Cornell Medical Center

mdj9003@med.cornell.edu

+1 646 962 2270

Study Officials

• Mehraneh Jafari, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 7, 2021
• First Posted: July 16, 2021
• Study Start: August 9, 2021
• Primary Completion: April 15, 2024
• Study Completion: September 16, 2024
• Last Updated: June 6, 2025
• Results First Posted: June 6, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)