NCT07587619

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P50-P75 for phase_1 colorectal-cancer

Timeline
1mo left

Started Sep 2024

Shorter than P25 for phase_1 colorectal-cancer

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress94%
Sep 2024Jul 2026

Study Start

First participant enrolled

September 3, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 17, 2025

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 7, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 14, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Expected
Last Updated

May 20, 2026

Status Verified

March 1, 2026

Enrollment Period

1 year

First QC Date

May 7, 2026

Last Update Submit

May 18, 2026

Conditions

Colorectal CancerDiverticulitis of Sigmoid

Keywords

perfusioncolorectal anastomosisStO2endoscopic perfusion monitoring

Outcome Measures

Primary Outcomes (1)

  • Anastomotic leak

    30 days

Study Arms (1)

Fujifilm monitoring

EXPERIMENTAL

Fujifilm monitoring

Device: Fujifilm monitoring

Interventions

Fujifilm monitoringDEVICE

Monitoring with Fujifilm ELUXEO device endoscopically \& laparoscopically

Fujifilm monitoring

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Southern California

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Sang Lee

    University of Southern California

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Colon and Rectal Surgery and Costello Clinical Professor at Keck Medicine of USC

Study Record Dates

First Submitted

May 7, 2026

First Posted

May 14, 2026

Study Start

September 3, 2024

Primary Completion

September 17, 2025

Study Completion (Estimated)

July 1, 2026

Last Updated

May 20, 2026

Record last verified: 2026-03

Locations

US(1)