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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-14

Study Completion Date

2018-09-14

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Sigmoid Diverticulosis Sigmoid Diverticulitis Colorectal Malignancy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Left-sided colonic resection

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No