Colorectal CancerANSCRSNCT03958500
The Problem of Colorectal Anastomosis Safety
A study testing Indocyanine green fluorescent angiography intraluminally and intraperitoneally in people with Colorectal Cancer and Colorectal Carcinoma, run by Vilnius University at 2 sites in Lithuania.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Colorectal Cancer, Colorectal Carcinoma, Colorectal Neoplasms
- What is being tested?
- Indocyanine green fluorescent angiography intraluminally and intraperitoneally
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesLithuania
- Study dates
- 1 Apr 2019to 31 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients over 18 year
- signed written consent
- a colorectal anastomosis lower 15 cm from anal verge
- elective surgery
Who cannot join
- allergy to indocyanine green dye
- pregnancy
Trial locations and contacts
2 sites in 1 country.
Lithuania2 sites
National Cancer Institute, Vilnius, Lithuania
Vilnius
Vilnius University hospital Santaros klinikos
Vilnius
About this study
Official title: 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.
- Being tested
- Indocyanine green fluorescent angiography intraluminally and intraperitoneally
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indocyanine green fluorescent angiography intraluminally and intraperitoneallyProcedure or surgery
Also called Air leak test, Methylene blue test
The use of indocyanine green fluorescent angiography to check bowel and anastomosis viability in standard low anterior rectal anastomosis
| Study group | Role | What they receive |
|---|---|---|
| Comprehensive anastomotic testing | Experimental | All patients undergo:
1. Indocyanine green fluorescent angiography intraluminally and intraperitoneally
2. Air leak test
3. Methylene blue test Receives: Procedure: Indocyanine green fluorescent angiography intraluminally and intraperitoneally |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0 to 60 days
Secondary outcomes (8)
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).
Measured: 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.
Measured: 0 to 60 days
Reoperation rate
Patients, who needed re-interventions
Measured: 0 to 60 days
Intraoperative test leakage
Leakage rate detected intraoperatively after anastomosis testing
Measured: 0 to 600 minutes
Time of anastomosis testing
Time from the start of the anastomosis testing till the end
Measured: 0 to 600 minutes
Operation time
Time from the start of the operation until the end of the operation
Measured: 0 to 600 minutes
90 days mortality
the mortality of the patients after the operation
Measured: 0 to 90 days
Timing of anastomosis leakage
In days after surgery
Measured: 0 to 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2019
- Study start1 Apr 2019
- Primary completion30 Dec 2021
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vilnius University
- Sponsor type
- University, hospital or other
- Collaborators
- Vilnius University Hospital Santaros Klinikos, National Cancer Center Affiliate of Vilnius University Hospital Santaros Klinikos
- Responsible party
- Principal investigator, Marius Kryzauskas, Vilnius University
- Investigators
- Eligijus Poskus, prof., Principal investigator, Vilnius University, Vilnius, Lithuania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03958500
- Sponsor's protocol ID
- 2019/3-1116-608
- Acronym
- ANSCRS
- Status last verified
- May 2022
- First submitted
- 17 Apr 2019
- Last updated
- 3 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 31914032
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Problem of Safety of Anastomosis in Colorectal Surgery and Search for the Solutions
- ClinicalTrials.gov ID
- NCT03958500
- Acronym / sponsor ID
- ANSCRS / 2019/3-1116-608
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Vilnius UniversityUniversity, hospital or other
- Collaborators
- Vilnius University Hospital Santaros Klinikos, National Cancer Center Affiliate of Vilnius University Hospital Santaros Klinikos
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 22 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Comprehensive anastomotic testing | Experimental | Procedure: Indocyanine green fluorescent angiography intraluminally and intraperitoneallyAll patients undergo: 1. Indocyanine green fluorescent angiography intraluminally and intraperitoneally 2. Air leak test 3. Methylene blue test |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients over 18 year
- signed written consent
- a colorectal anastomosis lower 15 cm from anal verge
- elective surgery
Key exclusion criteria (2 listed)
- allergy to indocyanine green dye
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Indocyanine green fluorescent angiography intraluminally and intraperitoneallyAlso: Air leak test, Methylene blue testThe use of indocyanine green fluorescent angiography to check bowel and anastomosis viability in standard low anterior rectal anastomosis | Procedure or surgery | Comprehensive anastomotic testing |
Primary outcome
Rate of anastomotic leakage
Time frame: 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.
8 secondary outcomes
Quality of life before and after the operation
Time frame: 0 to 60 days
Quality of life before and after the operation
Time frame: 0 to 60 days
Reoperation rate
Time frame: 0 to 60 days
Intraoperative test leakage
Time frame: 0 to 600 minutes
Time of anastomosis testing
Time frame: 0 to 600 minutes
Operation time
Time frame: 0 to 600 minutes
90 days mortality
Time frame: 0 to 90 days
Timing of anastomosis leakage
Time frame: 0 to 60 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2022.
- Derived from this study: PubMed 31914032Kryzauskas 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.
- ProtocolLink provided by the sponsor.
- Study resultsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eligijus Poskus, prof. principal investigator
Vilnius University, Vilnius, Lithuania
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Indocyanine green fluorescent angiography intraluminally and intraperitoneally in people with Colorectal Cancer and Colorectal Carcinoma, run by Vilnius University at 2 sites in Lithuania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of anastomotic leakage (time frame: 0 to 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03958500, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2022.