TERMINATED

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-08-09
Study Completion:2024-09-16
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:TERMINATED

Study ID

NCT04964297

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male or female ≥ 18 years of age.
  2. * Documentation of a required elective right laparoscopic hemicolectomy with intracorporeal anastomosis
  3. * Subject signed inform consent
  1. * Less than 18 years old
  2. * Pregnant or breastfeeding patients
  3. * Patients undergoing emergency laparotomy for perforated right colon or trauma
  4. * Patients with Intraabdominal abscess, peritonitis, or enteric fistula
  5. * Patients who are on peritoneal dialysis
  6. * Subjects do not speak English

Contacts and Locations

Principal Investigator

Mehraneh Jafari, MD
PRINCIPAL_INVESTIGATOR
Weill Medical College of Cornell University

Study Locations (Sites)

Weill Cornell Medicine
New York, New York, 10065
United States

Collaborators and Investigators

Sponsor: Weill Medical College of Cornell University

  • Mehraneh Jafari, MD, PRINCIPAL_INVESTIGATOR, Weill Medical College of Cornell University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-08-09
Study Completion Date2024-09-16

Study Record Updates

Study Start Date2021-08-09
Study Completion Date2024-09-16

Terms related to this study

Keywords Provided by Researchers

  • Colon cancer, Crohn's disease, Perf-AlertTM device, Hydrogen gas(H2), gas Methane (CH4)

Additional Relevant MeSH Terms

  • Crohn's Disease of Large Intestine
  • Malignant Neoplasm of Colon