Intraoperative Use of Oxygen Saturation Imaging to Assess Intestinal Perfusion

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07587619

Enrollment

Registered

2026-05-14

Start date

2024-09-03

Completion date

2026-07-01

Last updated

2026-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer, Diverticulitis of Sigmoid

Keywords

perfusion, colorectal anastomosis, StO2, endoscopic perfusion monitoring

Brief summary

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.

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.

Interventions

DEVICEFujifilm monitoring

Monitoring with Fujifilm ELUXEO device endoscopically \& laparoscopically

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Anastomotic leak	30 days

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORSang Lee

University of Southern California

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 21, 2026