The Problem of Colorectal Anastomosis Safety (ANSCRS)

Vilnius University

Status: Completed

Conditions: Colorectal Carcinoma; Colorectal Adenocarcinoma; Colorectal Neoplasms; Colorectal Cancer

Treatments: Procedure: Indocyanine green fluorescent angiography intraluminally and intraperitoneally

Study type: Interventional

Funder types: Other

Identifiers

NCT03958500

2019/3-1116-608

Details and patient eligibility

About

This is a prospective cohort pilot study. The investigators are planning to develop an original, standardized colorectal anastomosis inspection method, which will systemically inspect the anastomosis vascularity using the indocyanine green fluorescent angiography intraluminally and intraperitoneally, the air leak test, the methylene blue test, the tension in the anastomosis inspection, patients' risk factors scale sum. The summarized evaluation will determine the final anastomotic leak risk.

Enrollment: 60 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients over 18 year
• signed written consent
• a colorectal anastomosis lower 15 cm from anal verge
• elective surgery

Exclusion criteria

• allergy to indocyanine green dye
• pregnancy

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

60 participants in 1 patient group

Comprehensive anastomotic testing

Experimental group

Description:

All patients undergo: Indocyanine green fluorescent angiography intraluminally and intraperitoneally Air leak test Methylene blue test

Treatment:

Procedure: Indocyanine green fluorescent angiography intraluminally and intraperitoneally