Evaluation of Intestinal Vascolarization With Indocianine Green Angiography During Rectal Resection or Left Colectomy
1 other identifier
interventional
208
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2016
CompletedFirst Submitted
Initial submission to the registry
January 21, 2016
CompletedFirst Posted
Study publicly available on registry
January 26, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2017
CompletedNovember 6, 2017
November 1, 2017
1.8 years
January 21, 2016
November 2, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Anastomotic leak rate
30 days
Study Arms (2)
ICG- angiography
EXPERIMENTALColonic 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
No angiography
ACTIVE COMPARATORSubjective measures are employed to determine anastomotic perfusion
Interventions
Angiography with ICG prior to and after anastomosis. Extension of colon resection based on ICG angiography results
Eligibility Criteria
You may qualify if:
- adult patiens
- laparoscopic rectal resection or left colectomy
You may not qualify if:
- rectal amputation
- no anastomosis
- allergy to iodine or indocyanine green
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
San Raffaele Scientific Institute
Milan, 20129, Italy
Related Publications (1)
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.
PMID: 30903276DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paola De Nardi, MD
San Raffaele Scientific Institute
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
January 21, 2016
First Posted
January 26, 2016
Study Start
January 1, 2016
Primary Completion
October 1, 2017
Study Completion
November 1, 2017
Last Updated
November 6, 2017
Record last verified: 2017-11
Data Sharing
- IPD Sharing
- Will not share