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Objective Perfusion Rate Assessment by Near-infrared Fluorescence in Ileal Pouch Formation and Ileal-pouch-anal Anastomosis

NCT04695964 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2021-01-15

No results posted yet for this study

Summary

In this prospective, non-randomized cohort study, real-time intraoperative visualization using near-infrared-fluorescence by indocyanine green injection (ICG-NIRF) is performed at three time points during ileal pouch reconstruction. Postoperatively, a detailed software-based assessment of each pouch recording is performed to determine the objective ICG-NIRF perfusion rate, which is then correlated with the 30 day postoperative clinical outcome including occurrence of anastomotic leak of the pouch.

Conditions

Interventions

DIAGNOSTIC_TEST

ICG-NIRF Imaging plus ingress and egress analysis

intraoperative NIRF Imaging using the fluorescence agent ICG (indocyanine-green) at regions of interest before (T1) + after pouch construction (T2) + after ileoanal anastomosis (T3) Additional ingress and egress analysis (inflow and outflow analysis) of specificities regions of interest at regions of interest before (T1) + after pouch construction (T2) + after ileoanal anastomosis (T3)

Sponsors & Collaborators

  • Charite University, Berlin, Germany

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-01
Primary Completion
2021-01-31
Completion
2021-01-31

Countries

  • Germany

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04695964 on ClinicalTrials.gov