The Problem of Colorectal Anastomosis Safety (ANSCRS)

V

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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