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Evaluation of Intestinal Vascolarization With Indocianine Green Angiography During Rectal Resection or Left Colectomy

Primary Purpose

Rectal Disease, Sigmoid Disease

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
ICG- angiography
No angiography
Sponsored by
Scientific Institute San Raffaele
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Rectal Disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • adult patiens
  • laparoscopic rectal resection or left colectomy

Exclusion Criteria:

  • rectal amputation
  • no anastomosis
  • allergy to iodine or indocyanine green

Sites / Locations

  • San Raffaele Scientific Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ICG- angiography

No angiography

Arm Description

Colonic resection margins and colo-rectal anastomosis are intraoperatively assessed using fluorescence angiography to evaluate colonic perfusion. If perfusion at the resection margin is judged "insufficient" the colon is re-resected to obtain a satisfactory perfusion

Subjective measures are employed to determine anastomotic perfusion

Outcomes

Primary Outcome Measures

Anastomotic leak rate

Secondary Outcome Measures

Full Information

First Posted
January 21, 2016
Last Updated
November 2, 2017
Sponsor
Scientific Institute San Raffaele
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1. Study Identification

Unique Protocol Identification Number
NCT02662946
Brief Title
Evaluation of Intestinal Vascolarization With Indocianine Green Angiography During Rectal Resection or Left Colectomy
Official Title
Evaluation of Intestinal Vascolarization by Intraoperative Angiography With Indocianine Green During Laparoscopi Rectal Resection or Left Colectomy: Predictive Value on Anastomotic Leak.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
January 2016 (Actual)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
November 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Scientific Institute San Raffaele

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
A randomized controlled multicenter trial on the usefulness of intraoperative angiography with indocyanine green to assess anastomosis perfusion in patients who undergo laparoscopic rectal resection or left colectomy.
Detailed Description
Anastomotic leakage after colorectal surgery is a severe complication. One possible cause of anastomotic leakage is insufficient vascular supply. The aim of this study is to evaluate the usefulness of intraoperative assessment of vascular anastomotic perfusion in laparoscopic colorectal surgery using indocyanine green (ICG)-enhanced fluorescence, in order to assess if the information of the ICG angiography could lead to change the site of resection and improving the anastomotic leak rate. Two-hundred and eight patients, undergoing rectal resection or left colectomy, for benign or malignant disease, with high vessels ligation, will be randomized intro 2 arms: ICH angiography (colonic perfusion is intraoperatively assed with ICG angiography and level of resection is selected based on the fluorescence) and Control (resection is performed with subjective judgment). The rate of postoperative leak in the two groups will be recorded.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Disease, Sigmoid Disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
208 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ICG- angiography
Arm Type
Experimental
Arm Description
Colonic resection margins and colo-rectal anastomosis are intraoperatively assessed using fluorescence angiography to evaluate colonic perfusion. If perfusion at the resection margin is judged "insufficient" the colon is re-resected to obtain a satisfactory perfusion
Arm Title
No angiography
Arm Type
Active Comparator
Arm Description
Subjective measures are employed to determine anastomotic perfusion
Intervention Type
Procedure
Intervention Name(s)
ICG- angiography
Intervention Description
Angiography with ICG prior to and after anastomosis. Extension of colon resection based on ICG angiography results
Intervention Type
Procedure
Intervention Name(s)
No angiography
Intervention Description
Extension of resection based on subjective measures
Primary Outcome Measure Information:
Title
Anastomotic leak rate
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: adult patiens laparoscopic rectal resection or left colectomy Exclusion Criteria: rectal amputation no anastomosis allergy to iodine or indocyanine green
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paola De Nardi, MD
Organizational Affiliation
San Raffaele Scientific Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Raffaele Scientific Institute
City
Milano
ZIP/Postal Code
20129
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30903276
Citation
De Nardi P, Elmore U, Maggi G, Maggiore R, Boni L, Cassinotti E, Fumagalli U, Gardani M, De Pascale S, Parise P, Vignali A, Rosati R. Intraoperative angiography with indocyanine green to assess anastomosis perfusion in patients undergoing laparoscopic colorectal resection: results of a multicenter randomized controlled trial. Surg Endosc. 2020 Jan;34(1):53-60. doi: 10.1007/s00464-019-06730-0. Epub 2019 Mar 21.
Results Reference
derived

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Evaluation of Intestinal Vascolarization With Indocianine Green Angiography During Rectal Resection or Left Colectomy

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