The Problem of Colorectal Anastomosis Safety

NCT ID: NCT03958500

Last Updated: 2022-06-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-01

Study Completion Date

2022-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Colorectal Cancer Colorectal Carcinoma Colorectal Neoplasms Colorectal Adenocarcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Comprehensive anastomotic testing

All patients undergo:

1. Indocyanine green fluorescent angiography intraluminally and intraperitoneally
2. Air leak test
3. Methylene blue test

Group Type EXPERIMENTAL

Indocyanine green fluorescent angiography intraluminally and intraperitoneally

Intervention Type PROCEDURE

The use of indocyanine green fluorescent angiography to check bowel and anastomosis viability in standard low anterior rectal anastomosis

Interventions

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Indocyanine green fluorescent angiography intraluminally and intraperitoneally

The use of indocyanine green fluorescent angiography to check bowel and anastomosis viability in standard low anterior rectal anastomosis

Intervention Type PROCEDURE

Other Intervention Names

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Air leak test Methylene blue test

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vilnius University hospital Santaros klinikos, Vilnius, Lithuania

UNKNOWN

Sponsor Role collaborator

National Cancer Center Affiliate of Vilnius University Hospital Santaros Klinikos

OTHER

Sponsor Role collaborator

Vilnius University

OTHER

Sponsor Role lead

Responsible Party

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Marius Kryzauskas

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eligijus Poskus, prof.

Role: PRINCIPAL_INVESTIGATOR

Vilnius University, Vilnius, Lithuania

Locations

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National Cancer Institute, Vilnius, Lithuania

Vilnius, , Lithuania

Site Status

Vilnius University hospital Santaros klinikos

Vilnius, , Lithuania

Site Status

Countries

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Lithuania

References

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Kryzauskas M, Poskus E, Dulskas A, Bausys A, Jakubauskas M, Imbrasaite U, Makunaite G, Kuliavas J, Bausys R, Stratilatovas E, Strupas K, Poskus T. The problem of colorectal anastomosis safety. Medicine (Baltimore). 2020 Jan;99(2):e18560. doi: 10.1097/MD.0000000000018560.

Reference Type DERIVED
PMID: 31914032 (View on PubMed)

Related Links

Other Identifiers

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2019/3-1116-608

Identifier Type: -

Identifier Source: org_study_id

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