Endoscopic COlorectal Mucosal Evaluation of Oxygen Tension

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorVanderbilt University Medical Center

About this trial

Anastomosis refers to the surgical connection between two segments of the bowel, typically performed during colon and rectal surgeries to restore the continuity of the digestive tract after a section has been removed. It is necessary that the ends of the tissue at the anastomotic site are healthy (and capable of healing properly) as this will prevent dreaded complications like anastomotic leaks or strictures which can occur in almost a fifth of patients leading to increased hospital length of stay, costs, and mortality.

Currently, the most widely used method for assessing tissue viability during anastomosis is indocyanine green fluorescence angiography (ICG-FA). This technique involves injecting a fluorescent dye (indocyanine green) into the bloodstream, which highlights blood flow and tissue perfusion under a special camera. However, ICG-FA has limitations due to allergies and reliability due to the dye's rapid disappearance from the bloodstream. Additionally, the dye cannot be administered repeatedly. This study explores a new method of measuring tissue oxygenation by evaluating mucosal oxygen saturation (StO2) as an alternative to ICG-FA. By evaluating StO2 levels, the research aims to provide a more reliable and repeatable way to assess tissue viability without the drawbacks of using fluorescent dyes. Secondly, any blood supply interruption to the bowel will first lead to mucosal ischemia, which can potentially be reliably captured by measuring mucosal StO2 levels only.

In this single-center prospective single-arm study, we will evaluate whether mucosal StO2 levels are associated with or can predict anastomotic complications. This study will not involve any intervention that would affect the standard of care.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patients (≥18 years).

Undergoing a colo-rectal anastomosis.

Patients who consent to study participation

Disqualifiers

Patients undergoing a revision surgery.

Participants with missing data.

Patients who do not undergo intraoperative ICG-FA and StO2 endoscopic imaging promptly after the formation of a viable anastomosis.

Trial population

Patients meeting the eligibility criteria will be enrolled from the institution's colorectal surgery clinic in Nashville, TN

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • A novel endoscopic imaging system that displays real-time oxygen saturation levels

    Device

    The imaging system in this study maps mucosal oxygen tension, where tissue first shows signs of hypoxia, rather than serosal oxygen tension, which has been the focus of previous studies

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Anastomotic complications

leaks and strictures

Time frame
30 days

Secondary outcomes

1

Surgical complications

Surgical complications will be defined as any complication considered at least Grade I using the Clavien-Dindo classification system

Time frame
30 days
2

Surgical site infections

Surgical site infections will be determined according to The Centers for Disease Control Surgical Site Infection Criteria and will include incision site and local infections at sites of organ manipulation.

Time frame
30 days
3

Respiratory infections

A respiratory infection will be defined by a new or progressive infiltrate on chest radiography along with ≥2 of the following: WBC count \>1.1 x 103/mm3 or \< 4.5 x 103/mm3, purulent sputum, fever of \>38°C or any new-onset signs of inflammation on auscultation.

Time frame
30 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Vanderbilt University Medical Center

Lead sponsor

FujiFilm HealthCare Americas Corporation

Collaborator