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

February 9, 2021 updated by: IHU Strasbourg
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Accurate intraoperative evaluation of peri-anastomotic gastrointestinal tract perfusion is essential to reduce the risk of anastomotic complications such as leakage or strictures. Anastomotic leakage is the most dreadful complication of colorectal resections.

Intestinal microcirculation and viability is usually estimated from the color of the serosal surface, presence of peristalsis, pulsation and bleeding from the marginal arteries. This is subjective and based on the experience of the surgeon.

Fluorescence videography integrates a near-infrared endoscope able to detect the signal emitted by a fluorescent dye, Indocyanine Green (ICG), which is administered by intravenous injection. Fluorescence intensity is proportional to the amount of fluorescent dye diffused in the tissue and it consequently is a surrogate marker of tissue perfusion.

The hypothesis is that ICG-fluorescence guidance coupled with enhanced reality would allow a precise and rapid localization of the future anastomotic site in terms of optimal perfusion in laparoscopic colorectal resections.

In patients undergoing elective left-sided colonic resection by laparoscopic approach, resection site and anastomosis perfusion will be evaluated by :

  • the visual appreciation of the surgeon
  • the fluorescence-based enhanced reality, after injection of ICG and digital process.

A series of peri-operative samplings will also be carried out. In any case, the resection will be performed according to the surgeon's appreciation.

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Strasbourg, France, 67091
        • Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient, male or female, from 18 years old
  • Patient with sigmoid diverticulosis or diverticulitis
  • Patient with colon malignancy
  • Patient with rectum malignancy
  • Patient with no contraindication to anesthesia and to colonic resection surgery
  • Patient able to understand the study and to provide informed consent
  • Patient affiliated to the French social security system

Exclusion Criteria:

  • Patient undergoing emergency surgery
  • Patient undergoing abdomino-perineal resection
  • Patient undergoing colonic resection without anastomosis (Hartmann's colostomy)
  • Patient with proven or unclear allergic reactions
  • Pregnancy or breast-feeding
  • Patient in exclusion period (determined by a previous study or in progress)
  • Patient in custody
  • Patient under guardianship

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Perfusion evaluation of anastomosis
During left-sided colonic resections, anastomosis perfusion will be estimated by the visual appreciation of the surgeon and the ICG fluorescence-based enhanced reality. These two approaches will be compared.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between the perfusion evaluated by the ICG fluorescence-based enhanced reality and the metabolic state of the intestine
Time Frame: During surgery
The perfusion evaluated by the ICG fluorescence-based enhanced reality, obtained by the digital process of the fluorescence dynamic signal, will be correlated to the metabolic state of the intestine, assessed by the measure of biological markers on several points of the intestine.
During surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between the intraoperative intestinal perfusion and the rate of anastomosis leakage
Time Frame: During surgery
The intraoperative intestinal perfusion on the anastomosis site, measured by fluorescence videography, will be correlated to the rate of anastomosis leakage.
During surgery
Distance between the resection site based on the surgeon's appreciation and the resection site based on the digital analysis and the peri-operative samplings
Time Frame: During surgery
The distance between the resection site based on the surgeon's clinic appreciation and the resection site based on the digital analysis and the level of capillary lactates and mitochondria respiratory rate on different sites will be measured.
During surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IHU Strasbourg

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 14, 2016

Primary Completion (Actual)

September 14, 2018

Study Completion (Actual)

September 14, 2018

Study Registration Dates

First Submitted

December 3, 2015

First Submitted That Met QC Criteria

December 7, 2015

First Posted (Estimate)

December 10, 2015

Study Record Updates

Last Update Posted (Actual)

February 12, 2021

Last Update Submitted That Met QC Criteria

February 9, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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