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Perfusion Evaluation by Real-time Fluorescence-based Enhanced Reality of Anastomosis

NCT02626091 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2021-02-12

No results posted yet for this study

Summary

The aim of this study is to evaluate the ability of a ICG-fluorescence guidance complemented with enhanced reality to correctly document intestinal pre-anastomotic perfusion and to validate the accuracy of this technique with metabolic intestinal cells changes.

Conditions

  • Sigmoid Diverticulosis
  • Sigmoid Diverticulitis
  • Colorectal Malignancy

Interventions

PROCEDURE

Left-sided colonic resection

During interventions, anastomosis perfusion will be estimated (outcomes: visual appreciation of the surgeon, ICG fluorescence-based enhanced reality and series of peri-operative samplings) in order to validate the accuracy of ICG fluorescence-based enhanced reality technique. In any case, the resection will be performed according to the surgeon's appreciation.

Sponsors & Collaborators

  • IHU Strasbourg

    lead OTHER

Principal Investigators

  • Didier Mutter, MD, PhD · Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil de Strasbourg

  • Michele Diana, MD · IHU Strasbourg

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-14
Primary Completion
2018-09-14
Completion
2018-09-14

Countries

  • France

Study Locations

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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 NCT02626091 on ClinicalTrials.gov