Intraoperative Use of Oxygen Saturation Imaging to Assess Intestinal Perfusion

This will be a prospective, observational study of patients undergoing laparoscopic colorectal resection with anastomosis. After anastomosis creation and at the time of routine intraoperative flexible sigmoidoscopy, 4 mucosal StO2 measurements will be taken endoscopically and 4 corresponding serosal StO2 measurements will be taken laparoscopically. Measurements will be recorded in a prospectively maintained database along with operative findings and clinical outcomes. Longitudinal data will be obtained via chart review to track longer-term outcomes.

Study Overview

• Status: Active, not recruiting
• Conditions: Colorectal Cancer; Diverticulitis of Sigmoid
• Intervention / Treatment: Device: Fujifilm monitoring

Detailed Description

This will be a prospective, observational study of sequential patients undergoing laparoscopic colorectal resection with intestinal anastomosis. After anastomosis creation and at the time of routine intraoperative flexible sigmoidoscopy, 4 mucosal StO2 measurements will be taken endoscopically using the Endoscope EC-740T/L: (1) proximal to the staple/suture line, (2) proximal edge of the staple/suture line, (3) distal edge of the staple/suture line, (4) distal to the staple/suture line. Concurrently, 4 corresponding serosal StO2 measurements will be taken laparoscopically using the Video Laparoscope EL-R740M or EL-R740M30. Measurements will be recorded in a prospectively maintained database along with operative findings and clinical outcomes. Longitudinal data will be obtained via chart review to track longer-term outcomes.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • University of Southern California

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients 18 years or older who can understand and provide informed consent
• Patients undergoing laparoscopic colorectal resection and intestinal anastomosis

Exclusion Criteria:

• Patients younger than 18 years old
• Patients who do not understand the study, are unable to provide consent, or refuse to provide consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fujifilm monitoring	Device: Fujifilm monitoring; Monitoring with Fujifilm ELUXEO device endoscopically & laparoscopically

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Anastomotic leak	30 days

Collaborators and Investigators

• Sponsor: University of Southern California
• Collaborators: Fujifilm
• Investigators: Principal Investigator: Sang Lee, University of Southern California

Study record dates

Study Major Dates

• Study Start (Actual): September 3, 2024
• Primary Completion (Actual): September 17, 2025
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: May 7, 2026
• First Submitted That Met QC Criteria: May 7, 2026
• First Posted (Actual): May 14, 2026

Study Record Updates

• Last Update Posted (Actual): May 20, 2026
• Last Update Submitted That Met QC Criteria: May 18, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: colorectal anastomosis; perfusion; StO2; endoscopic perfusion monitoring
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 23-02233

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No