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

Scientific Institute San Raffaele

Status: Completed

Conditions: Sigmoid Disease; Rectal Disease

Treatments: Procedure: No angiography; Procedure: ICG- angiography

Study type: Interventional

Funder types: Other

Identifiers

NCT02662946

Angio-Co-Re

Details and patient eligibility

About

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.

Full 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.

Enrollment: 208 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult patiens
• laparoscopic rectal resection or left colectomy

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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208 participants in 2 patient groups

ICG- angiography

Experimental group

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

Treatment:

Procedure: ICG- angiography

No angiography

Active Comparator group

Description:

Subjective measures are employed to determine anastomotic perfusion

Treatment:

Procedure: No angiography