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The Impact of Indocyanine Green-enhanced Fluorescence Imaging on Bowel Transection in Left-sided Colorectal Resection

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ClinicalTrials.gov Identifier: NCT02669485
Recruitment Status : Unknown
Verified January 2016 by Dr. Dominic C.C. Foo, The University of Hong Kong.
Recruitment status was:  Recruiting
First Posted : February 1, 2016
Last Update Posted : February 1, 2016
Sponsor:
Information provided by (Responsible Party):
Dr. Dominic C.C. Foo, The University of Hong Kong

Brief Summary:
The aim of this study was to evaluate the impact of fluorescence imaging on the location of colorectal transection lines based on evaluation of perfusion with indocyanine green, how it's going to affect surgical planning and its possible benefits in reducing anastomotic leakage.

Condition or disease Intervention/treatment Phase
Anastomotic Leak Drug: indocyanine green Device: Fluorescence imaging Not Applicable

Detailed Description:
During surgery, the line of intended bowel transection would be determined by the surgeon. Then the anesthesiologist will administer a bolus of 5mg ICG intravenously (2.5mg/ml, 2ml), followed by 10ml normal saline flush. The perfusion of colon will be assessed via fluorescence angiography. The actual bowel transection, after ICG fluorescence study, would be compared with the intended bowel transection site. The difference in terms of distance and either more proximal or distal is recorded. Then bowel anastomosis is completed in the usual manner.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Prospective Study to Investigate the Impact of Using Indocyanine Green-enhanced Fluorescence Imaging on the Location of Bowel Transection in Patients Undergoing Left-sided Colorectal Resection
Study Start Date : January 2016
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ICG
Administering indocyanine green during surgery and the use of ICG fluorescence imaging to assess bowel perfusion during surgery
Drug: indocyanine green
Injection of indocyanine green and using fluorescence imaging to assess perfusion of bowel before bowel transection and anastomosis

Device: Fluorescence imaging



Primary Outcome Measures :
  1. Number of patients with operative decisions changed after the use of ICG enhanced fluorescence imaging [ Time Frame: intraoperative ]

Secondary Outcome Measures :
  1. Anastomotic leak [ Time Frame: up to 2 weeks after operation ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All left-sided colorectal resection involving division of inferior mesenteric artery

Exclusion Criteria:

  • Patients with a history of adverse reaction or known allergy to ICG, iodine, or iodine dyes. Pregnant and/or lactating patients.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02669485


Contacts
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Contact: Dominic, Chi Chung Foo, MBBS 85222554389 ccfoo@hku.hk

Locations
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Hong Kong
Queen Mary Hospital Recruiting
Hong Kong, Hong Kong
Contact: Dominic, Chi Chung Foo, MBBSA    85222554389    ccfoo@hku.hk   
Contact: Nga Fun Shumj, PhD    85222551250    frankie_shum2002@yahoo.com.hk   
Principal Investigator: Dominic, Chi Chung Foo, MBBS         
Sponsors and Collaborators
The University of Hong Kong
Investigators
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Principal Investigator: Dominic, Chi Chung Foo, MBBS The University of Hong Kong
Publications:
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Responsible Party: Dr. Dominic C.C. Foo, Clinical Assistant Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT02669485    
Other Study ID Numbers: UW 16027
First Posted: February 1, 2016    Key Record Dates
Last Update Posted: February 1, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Dr. Dominic C.C. Foo, The University of Hong Kong:
ICG
colectomy
anastomotic leak
anastomotic leakage rate
surgical decision
Additional relevant MeSH terms:
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Anastomotic Leak
Postoperative Complications
Pathologic Processes