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Completed

NCT Number: NCT02662946

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

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.

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Key information

Conditions

Rectal Disease Colonic Diseases Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Rectal Diseases Sigmoid Disease Sigmoid Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

San Raffaele Scientific Institute

Milan, 20129, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • adult patiens
  • laparoscopic rectal resection or left colectomy

Exclusion criteria

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

Treatment and study plan

ICG- angiography

Procedure

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

No angiography

Procedure

Extension of resection based on subjective measures

Primary outcomes

  1. Anastomotic leak rate

    Time frame: 30 days

Sponsors and collaborators

Lead sponsor

Scientific Institute San Raffaele

Other

Registry information

Official study title

Evaluation of Intestinal Vascolarization by Intraoperative Angiography With Indocianine Green During Laparoscopi Rectal Resection or Left Colectomy: Predictive Value on Anastomotic Leak.

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jan 26, 2016
Registry last updated
Nov 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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