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

NCT ID: NCT02662946

Last Updated: 2017-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

208 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2017-11-30

Brief Summary

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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

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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.

Conditions

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Rectal Disease Sigmoid Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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ICG- angiography

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

Group Type EXPERIMENTAL

ICG- angiography

Intervention Type PROCEDURE

Angiography with ICG prior to and after anastomosis. Extension of colon resection based on ICG angiography results

No angiography

Subjective measures are employed to determine anastomotic perfusion

Group Type ACTIVE_COMPARATOR

No angiography

Intervention Type PROCEDURE

Extension of resection based on subjective measures

Interventions

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ICG- angiography

Angiography with ICG prior to and after anastomosis. Extension of colon resection based on ICG angiography results

Intervention Type PROCEDURE

No angiography

Extension of resection based on subjective measures

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* adult patiens
* laparoscopic rectal resection or left colectomy

Exclusion Criteria

* rectal amputation
* no anastomosis
* allergy to iodine or indocyanine green
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Scientific Institute San Raffaele

OTHER

Sponsor Role lead

Responsible Party

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Paola De Nardi

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Paola De Nardi, MD

Role: PRINCIPAL_INVESTIGATOR

San Raffaele Scientific Institute

Locations

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San Raffaele Scientific Institute

Milan, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type DERIVED
PMID: 30903276 (View on PubMed)

Other Identifiers

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Angio-Co-Re

Identifier Type: -

Identifier Source: org_study_id