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

NCT02626091 | Completed

• 1 other identifier: 15-005
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Sigmoid Diverticulosis; Sigmoid Diverticulitis; Colorectal Malignancy

Keywords

Anastomotic perfusion; ICG Fluorescence; Enhanced reality; Left-sided colonic resection

Outcome Measures

Primary Outcomes (1)

• 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.

  During surgery

Secondary Outcomes (2)

• Correlation between the intraoperative intestinal perfusion and 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

  During surgery

Study Arms (1)

Perfusion evaluation of anastomosis

EXPERIMENTAL

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

Interventions

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.

Perfusion evaluation of anastomosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 custody
• Patient under guardianship

Sponsors & Collaborators

• IHU Strasbourg: lead

Study Sites (1)

Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil

Strasbourg, 67091, France

Location

Related Publications (6)

• 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.

  PMID: 23532109 BACKGROUND

• 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.

  PMID: 24912446 BACKGROUND

• 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.

  PMID: 24935199 BACKGROUND

• 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.

  PMID: 25627131 BACKGROUND

• 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.

  PMID: 25303914 BACKGROUND

• 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.

  PMID: 32856153 DERIVED

Study Officials

• Didier Mutter, MD, PhD

  Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil de Strasbourg

  PRINCIPAL INVESTIGATOR

• Michele Diana, MD

  IHU Strasbourg

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2015
• First Posted: December 10, 2015
• Study Start: September 14, 2016
• Primary Completion: September 14, 2018
• Study Completion: September 14, 2018
• Last Updated: February 12, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)