The Problem of Colorectal Anastomosis Safety

Not Applicable

Completed

• Conditions: Colorectal Cancer; Colorectal Carcinoma; Colorectal Neoplasms; Colorectal Adenocarcinoma
• Interventions: Procedure: Indocyanine green fluorescent angiography intraluminally and intraperitoneally

• Registration Number: NCT03958500
• Lead Sponsor: Vilnius University

Brief Summary

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

Not available

Study Timeline

• Study Start: 2019-04-01
• Study First Submitted: 2019-04-17
• Study First Submitted QC: 2019-05-18
• Study First Posted: 2019-05-22
• Primary Completion: 2021-12-30
• Study Completion: 2022-01-31
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-31
• Last Update Posted: 2022-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Comprehensive anastomotic testing	Indocyanine green fluorescent angiography intraluminally and intraperitoneally	All patients undergo: 1. Indocyanine green fluorescent angiography intraluminally and intraperitoneally 2. Air leak test 3. Methylene blue test

Primary Outcome Measures

Name	Time	Method
Rate of anastomotic leakage	0 to 60 days	The number of patients, who had clinical or radiological anastomotic leakage. Proctography will be performed 6-8 days and 4-6 weeks after the primary operation.

Secondary Outcome Measures

Name	Time	Method
90 days mortality	0 to 90 days	the mortality of the patients after the operation
Time of anastomosis testing	0 to 600 minutes	Time from the start of the anastomosis testing till the end
Quality of life before and after the operation	0 to 60 days	Using QLQ-C30 questionnaire. To compare change in Quality of Life, as defined by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30 (Version 3)) before operation and 4-6 weeks after the operation.; The EORTC QLQ-C30 (Version 3) uses for the questions 1 to 28 a 4-point scale. The scale scores from 1 to 4: 1 ("Not at all"), 2 ("A little"), 3 ("Quite a bit") and 4 ("Very much"). Half points are not allowed. The range is 3. For the raw score, less points are considered to have a better outcome.; The EORTC QLQ-C30 (Version 3) uses for the questions 29 and 30 a 7-points scale. The scale scores from 1 to 7: 1 ("very poor") to 7 ("excellent"). Half points are not allowed. The range is 6. First of all, raw score has to be calculated with mean values. Afterwards linear transformation is performed to be comparable. More points are considered to have a better outcome.
Operation time	0 to 600 minutes	Time from the start of the operation until the end of the operation
Intraoperative test leakage	0 to 600 minutes	Leakage rate detected intraoperatively after anastomosis testing
Reoperation rate	0 to 60 days	Patients, who needed re-interventions
Timing of anastomosis leakage	0 to 60 days	In days after surgery

Trial Locations

Locations (2)

National Cancer Institute, Vilnius, Lithuania; 🇱🇹 Vilnius, Lithuania

Vilnius University hospital Santaros klinikos; 🇱🇹 Vilnius, Lithuania