The Problem of Colorectal Anastomosis Safety (ANSCRS)

Problem of Safety of Anastomosis in Colorectal Surgery and Search for the Solutions

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Neoplasms; Colorectal Cancer; Colorectal Carcinoma; Colorectal Adenocarcinoma
• Intervention / Treatment: Procedure: Indocyanine green fluorescent angiography intraluminally and intraperitoneally

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Lithuania
  • Vilnius, Lithuania
    • Vilnius University Hospital Santaros Klinikos
  • Vilnius, Lithuania
    • National Cancer Institute, Vilnius, Lithuania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 98 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Comprehensive anastomotic testing; All patients undergo: Indocyanine green fluorescent angiography intraluminally and intraperitoneally; Air leak test; Methylene blue test	Procedure: 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; Other Names: Air leak test; Methylene blue test

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of anastomotic leakage	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.	0 to 60 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life before and after the operation	Using low anterior resection syndrome score (the LARS score - simple 5 question questionnaire). LARS score is a tool consisting of five items, which are as follows: incontinence due to flatus (score range from 0 to 7), incontinence due to liquid stools (score range from 0 to 3), frequency of bowel movements (score range from 0 to 5), clustering (score range from 0 to 11) and urgency (score range from 0 to 16). The severity of each item is calculated on a scale ranging from 0 to 42, with a score of 0-20 (no LARS), 21-29 (minor LARS) and 30-42 (major LARS).	0 to 60 days
Quality of life before and after the operation	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.	0 to 60 days
Reoperation rate	Patients, who needed re-interventions	0 to 60 days
Intraoperative test leakage	Leakage rate detected intraoperatively after anastomosis testing	0 to 600 minutes
Time of anastomosis testing	Time from the start of the anastomosis testing till the end	0 to 600 minutes
Operation time	Time from the start of the operation until the end of the operation	0 to 600 minutes
90 days mortality	the mortality of the patients after the operation	0 to 90 days
Timing of anastomosis leakage	In days after surgery	0 to 60 days

Collaborators and Investigators

• Sponsor: Vilnius University
• Collaborators: National Cancer Institute, Lithuania; Vilnius University hospital Santaros klinikos, Vilnius, Lithuania
• Investigators: Principal Investigator: Eligijus Poskus, prof., Vilnius University, Vilnius, Lithuania

Publications and helpful links

General Publications

• 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.

Helpful Links

• Protocol
• Study results

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Actual): December 30, 2021
• Study Completion (Actual): January 31, 2022

Study Registration Dates

• First Submitted: April 17, 2019
• First Submitted That Met QC Criteria: May 18, 2019
• First Posted (Actual): May 22, 2019

Study Record Updates

• Last Update Posted (Actual): June 3, 2022
• Last Update Submitted That Met QC Criteria: May 31, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Methylene Blue
• Other Study ID Numbers: 2019/3-1116-608

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No