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

Rectal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02662946
• Other study ID #: Angio-Co-Re
• Status: Completed
• Phase: N/A
• First received: January 21, 2016
• Last updated: November 2, 2017
• Start date: January 2016
• Est. completion date: November 2017

Study information

• Verified date: November 2017
• Source: Scientific Institute San Raffaele
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 208
• Est. completion date: November 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• adult patiens

• laparoscopic rectal resection or left colectomy

Exclusion Criteria:

• rectal amputation

• no anastomosis

• allergy to iodine or indocyanine green

Related Conditions & MeSH terms

• Rectal Disease
• Rectal Diseases
• Sigmoid Disease
• Sigmoid Diseases

Intervention

Procedure:
• ICG- angiography
Angiography with ICG prior to and after anastomosis. Extension of colon resection based on ICG angiography results
• No angiography
Extension of resection based on subjective measures

Locations

Country	Name	City	State
Italy	San Raffaele Scientific Institute	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Scientific Institute San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anastomotic leak rate		30 days