Recruiting

Mucosal StO2

Sponsor:

Vanderbilt University Medical Center

Code:

NCT07467980

Conditions

Anastomotic Leak Rectum

Anastomotic Leak Large Intestine

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

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

Study Details

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

Study ID

NCT07467980

Start date

Mar 16, 2026

Status verified date

Jun, 2026

Completion date

Apr, 2028

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Study Design

Enrollment

80 participants

Anticipated

Interventions and Outcome Measures

Interventions

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

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

Primary outcome measure

  • Anastomotic complications [ Time Frame: 30 days ]

Central Contacts and Locations

Central contacts

Locations

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37212

Contacts

Vanderbilt Colon and Rectal Surgery

(615) 322-2063aimal.khan@vumc.org

More Information

Sponsor

Vanderbilt University Medical Center

Last update posted

Jun 11, 2026

Last verified

Jun, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vanderbilt University Medical Center on 2026-06-11.