Endoscopic COlorectal Mucosal Evaluation of Oxygen Tension

NCT07467980 | Not Yet Recruiting FDA Device

• 2 other identifiers: 250787VUMC131557
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Anastomotic Leak Rectum; Anastomotic Leak Large Intestine

Keywords

anastomotic leak; colorectal; endoscopic; oxygen tension; oxygen saturation; mucosal; colon; rectum

Outcome Measures

Primary Outcomes (1)

• Anastomotic complications

  leaks and strictures

  30 days

Secondary Outcomes (3)

• Surgical complications

  30 days

• Surgical site infections

  30 days

• Respiratory infections

  30 days

Interventions

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

Eligibility Criteria

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

Study Population

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

You may qualify if:

• Adult patients (≥18 years).
• Undergoing a colo-rectal anastomosis.
• Patients who consent to study participation

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• FujiFilm HealthCare Americas Corporation: collaborator

MeSH Terms

Conditions

Anastomotic Leak

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Aimal Khan

CONTACT

+1 (615)343-4612; aimal.khan@vumc.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Surgery

Study Record Dates

• First Submitted: March 8, 2026
• First Posted: March 12, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2028
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share