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

Not Applicable

Completed

• Conditions: Sigmoid Disease; Rectal Disease
• Interventions: Procedure: ICG- angiography; Procedure: No angiography

• Registration Number: NCT02662946
• Lead Sponsor: Scientific Institute San Raffaele

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.

Detailed 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.

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-01-21
• Study First Submitted QC: 2016-01-25
• Study First Posted: 2016-01-26
• Primary Completion: 2017-10
• Status Verified: 2017-11
• Study Completion: 2017-11
• Last Update Submitted: 2017-11-02
• Last Update Posted: 2017-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 208

Inclusion Criteria

• adult patiens
• laparoscopic rectal resection or left colectomy

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ICG- angiography	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
No angiography	No angiography	Subjective measures are employed to determine anastomotic perfusion

Primary Outcome Measures

Name	Time	Method
Anastomotic leak rate	30 days

Trial Locations

Locations (1)

San Raffaele Scientific Institute; 🇮🇹 Milano, Italy