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The Problem of Colorectal Anastomosis Safety (ANSCRS)

Primary Purpose

Colorectal Cancer, Colorectal Carcinoma, Colorectal Neoplasms

Status
Completed
Phase
Not Applicable
Locations
Lithuania
Study Type
Interventional
Intervention
Indocyanine green fluorescent angiography intraluminally and intraperitoneally
Sponsored by
Vilnius University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Colorectal Cancer

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • National Cancer Institute, Vilnius, Lithuania
  • Vilnius University hospital Santaros klinikos

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Comprehensive anastomotic testing

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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.
Reoperation rate
Patients, who needed re-interventions
Intraoperative test leakage
Leakage rate detected intraoperatively after anastomosis testing
Time of anastomosis testing
Time from the start of the anastomosis testing till the end
Operation time
Time from the start of the operation until the end of the operation
90 days mortality
the mortality of the patients after the operation
Timing of anastomosis leakage
In days after surgery

Full Information

First Posted
April 17, 2019
Last Updated
May 31, 2022
Sponsor
Vilnius University
Collaborators
Vilnius University hospital Santaros klinikos, Vilnius, Lithuania, National Cancer Institute, Lithuania
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1. Study Identification

Unique Protocol Identification Number
NCT03958500
Brief Title
The Problem of Colorectal Anastomosis Safety
Acronym
ANSCRS
Official Title
Problem of Safety of Anastomosis in Colorectal Surgery and Search for the Solutions
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
December 30, 2021 (Actual)
Study Completion Date
January 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vilnius University
Collaborators
Vilnius University hospital Santaros klinikos, Vilnius, Lithuania, National Cancer Institute, Lithuania

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Colorectal Carcinoma, Colorectal Neoplasms, Colorectal Adenocarcinoma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Comprehensive anastomotic testing
Arm Type
Experimental
Arm Description
All patients undergo: Indocyanine green fluorescent angiography intraluminally and intraperitoneally Air leak test Methylene blue test
Intervention Type
Procedure
Intervention Name(s)
Indocyanine green fluorescent angiography intraluminally and intraperitoneally
Other Intervention Name(s)
Air leak test, Methylene blue test
Intervention Description
The use of indocyanine green fluorescent angiography to check bowel and anastomosis viability in standard low anterior rectal anastomosis
Primary Outcome Measure Information:
Title
Rate of anastomotic leakage
Description
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.
Time Frame
0 to 60 days
Secondary Outcome Measure Information:
Title
Quality of life before and after the operation
Description
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).
Time Frame
0 to 60 days
Title
Quality of life before and after the operation
Description
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.
Time Frame
0 to 60 days
Title
Reoperation rate
Description
Patients, who needed re-interventions
Time Frame
0 to 60 days
Title
Intraoperative test leakage
Description
Leakage rate detected intraoperatively after anastomosis testing
Time Frame
0 to 600 minutes
Title
Time of anastomosis testing
Description
Time from the start of the anastomosis testing till the end
Time Frame
0 to 600 minutes
Title
Operation time
Description
Time from the start of the operation until the end of the operation
Time Frame
0 to 600 minutes
Title
90 days mortality
Description
the mortality of the patients after the operation
Time Frame
0 to 90 days
Title
Timing of anastomosis leakage
Description
In days after surgery
Time Frame
0 to 60 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eligijus Poskus, prof.
Organizational Affiliation
Vilnius University, Vilnius, Lithuania
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cancer Institute, Vilnius, Lithuania
City
Vilnius
Country
Lithuania
Facility Name
Vilnius University hospital Santaros klinikos
City
Vilnius
Country
Lithuania

12. IPD Sharing Statement

Citations:
PubMed Identifier
31914032
Citation
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.
Results Reference
derived
Links:
URL
https://journals.lww.com/md-journal/Fulltext/2020/01100/The_problem_of_colorectal_anastomosis_safety.23.aspx
Description
Protocol
URL
https://link.springer.com/article/10.1007/s00464-022-09093-1
Description
Study results

Learn more about this trial

The Problem of Colorectal Anastomosis Safety

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