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Completed

NCT Number: NCT02626091

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil

Strasbourg, 67091, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Left-sided colonic resection

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

IHU Strasbourg

Other

Registry information

Acronym: PERFECT

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Dec 10, 2015
Registry last updated
Feb 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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