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

Not Applicable

Completed

• Conditions: Colorectal Malignancy; Sigmoid Diverticulosis; Sigmoid Diverticulitis
• Interventions: Procedure: Left-sided colonic resection

• Registration Number: NCT02626091
• Lead Sponsor: IHU Strasbourg

Brief 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.

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 Timeline

• Study First Submitted: 2015-12-03
• Study First Submitted QC: 2015-12-07
• Study First Posted: 2015-12-10
• Study Start: 2016-09-14
• Primary Completion: 2018-09-14
• Study Completion: 2018-09-14
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-09
• Last Update Posted: 2021-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Perfusion evaluation of anastomosis	Left-sided colonic resection	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.

Primary Outcome Measures

Name	Time	Method
Correlation between the perfusion evaluated by the ICG fluorescence-based enhanced reality and the metabolic state of the intestine	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.

Secondary Outcome Measures

Name	Time	Method
Correlation between the intraoperative intestinal perfusion and the rate of anastomosis leakage	During surgery	The intraoperative intestinal perfusion on the anastomosis site, measured by fluorescence videography, will be correlated to the rate of anastomosis leakage.
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	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.

Trial Locations

Locations (1)

Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil; 🇫🇷 Strasbourg, France