Perfusion Evaluation by Real-time Fluorescence-based Enhanced Reality of Anastomosis (PERFECT)
Primary Purpose
Sigmoid Diverticulosis, Sigmoid Diverticulitis, Colorectal Malignancy
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Left-sided colonic resection
Sponsored by
About this trial
This is an interventional prevention trial for Sigmoid Diverticulosis focused on measuring Anastomotic perfusion, ICG Fluorescence, Enhanced reality, Left-sided colonic resection
Eligibility Criteria
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
Sites / Locations
- Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Perfusion evaluation of anastomosis
Arm Description
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.
Outcomes
Primary Outcome Measures
Correlation between the perfusion evaluated by the ICG fluorescence-based enhanced reality and the metabolic state of the intestine
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
Correlation between the intraoperative intestinal perfusion and the rate of anastomosis leakage
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02626091
Brief Title
Perfusion Evaluation by Real-time Fluorescence-based Enhanced Reality of Anastomosis
Acronym
PERFECT
Official Title
Perfusion Evaluation by Real-time Fluorescence-based Enhanced Reality of Anastomosis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
September 14, 2016 (Actual)
Primary Completion Date
September 14, 2018 (Actual)
Study Completion Date
September 14, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IHU Strasbourg
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sigmoid Diverticulosis, Sigmoid Diverticulitis, Colorectal Malignancy
Keywords
Anastomotic perfusion, ICG Fluorescence, Enhanced reality, Left-sided colonic resection
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Perfusion evaluation of anastomosis
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Left-sided colonic resection
Intervention Description
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 Outcome Measure Information:
Title
Correlation between the perfusion evaluated by the ICG fluorescence-based enhanced reality and the metabolic state of the intestine
Description
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.
Time Frame
During surgery
Secondary Outcome Measure Information:
Title
Correlation between the intraoperative intestinal perfusion and the rate of anastomosis leakage
Description
The intraoperative intestinal perfusion on the anastomosis site, measured by fluorescence videography, will be correlated to the rate of anastomosis leakage.
Time Frame
During surgery
Title
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
Description
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.
Time Frame
During surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Didier Mutter, MD, PhD
Organizational Affiliation
Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil de Strasbourg
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michele Diana, MD
Organizational Affiliation
IHU Strasbourg
Official's Role
Study Director
Facility Information:
Facility Name
Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil
City
Strasbourg
ZIP/Postal Code
67091
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
23532109
Citation
Diana M, Noll E, Diemunsch P, Dallemagne B, Benahmed MA, Agnus V, Soler L, Barry B, Namer IJ, Demartines N, Charles AL, Geny B, Marescaux J. Enhanced-reality video fluorescence: a real-time assessment of intestinal viability. Ann Surg. 2014 Apr;259(4):700-7. doi: 10.1097/SLA.0b013e31828d4ab3.
Results Reference
background
PubMed Identifier
24912446
Citation
Diana M, Halvax P, Dallemagne B, Nagao Y, Diemunsch P, Charles AL, Agnus V, Soler L, Demartines N, Lindner V, Geny B, Marescaux J. Real-time navigation by fluorescence-based enhanced reality for precise estimation of future anastomotic site in digestive surgery. Surg Endosc. 2014 Nov;28(11):3108-18. doi: 10.1007/s00464-014-3592-9. Epub 2014 Jun 10.
Results Reference
background
PubMed Identifier
24935199
Citation
Diana M, Dallemagne B, Chung H, Nagao Y, Halvax P, Agnus V, Soler L, Lindner V, Demartines N, Diemunsch P, Geny B, Swanstrom L, Marescaux J. Probe-based confocal laser endomicroscopy and fluorescence-based enhanced reality for real-time assessment of intestinal microcirculation in a porcine model of sigmoid ischemia. Surg Endosc. 2014 Nov;28(11):3224-33. doi: 10.1007/s00464-014-3595-6. Epub 2014 Jun 17.
Results Reference
background
PubMed Identifier
25627131
Citation
Diana M, Agnus V, Halvax P, Liu YY, Dallemagne B, Schlagowski AI, Geny B, Diemunsch P, Lindner V, Marescaux J. Intraoperative fluorescence-based enhanced reality laparoscopic real-time imaging to assess bowel perfusion at the anastomotic site in an experimental model. Br J Surg. 2015 Jan;102(2):e169-76. doi: 10.1002/bjs.9725.
Results Reference
background
PubMed Identifier
25303914
Citation
Boni L, David G, Mangano A, Dionigi G, Rausei S, Spampatti S, Cassinotti E, Fingerhut A. Clinical applications of indocyanine green (ICG) enhanced fluorescence in laparoscopic surgery. Surg Endosc. 2015 Jul;29(7):2046-55. doi: 10.1007/s00464-014-3895-x. Epub 2014 Oct 11.
Results Reference
background
PubMed Identifier
32856153
Citation
D'Urso A, Agnus V, Barberio M, Seeliger B, Marchegiani F, Charles AL, Geny B, Marescaux J, Mutter D, Diana M. Computer-assisted quantification and visualization of bowel perfusion using fluorescence-based enhanced reality in left-sided colonic resections. Surg Endosc. 2021 Aug;35(8):4321-4331. doi: 10.1007/s00464-020-07922-9. Epub 2020 Aug 27.
Results Reference
derived
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Perfusion Evaluation by Real-time Fluorescence-based Enhanced Reality of Anastomosis
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