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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Diverticulitis of Sigmoid Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of Southern California

Los Angeles, California, 90033, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fujifilm monitoring

Device

Monitoring with Fujifilm ELUXEO device endoscopically & laparoscopically

Primary outcomes

Anastomotic leak

Time frame: 30 days

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Collaborators

Fujifilm

Registry information

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2026
First posted: May 14, 2026
Registry last updated: May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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