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出境医 / 临床实验 / The Problem of Colorectal Anastomosis Safety (ANSCRS)

The Problem of Colorectal Anastomosis Safety (ANSCRS)

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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Colorectal Carcinoma Colorectal Neoplasms Colorectal Adenocarcinoma Procedure: Indocyanine green fluorescent angiography intraluminally and intraperitoneally Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Problem of Safety of Anastomosis in Colorectal Surgery and Search for the Solutions
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : February 1, 2020
Arms and Interventions
Arm Intervention/treatment
Experimental: Comprehensive anastomotic testing

All patients undergo:

  1. Indocyanine green fluorescent angiography intraluminally and intraperitoneally
  2. Air leak test
  3. 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
Outcome Measures
Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Quality of life before and after the operation [ Time Frame: 0 to 60 days ]
    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).

  2. Quality of life before and after the operation [ Time Frame: 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.


  3. Reoperation rate [ Time Frame: 0 to 60 days ]
    Patients, who needed re-interventions

  4. Intraoperative test leakage [ Time Frame: 0 to 600 minutes ]
    Leakage rate detected intraoperatively after anastomosis testing

  5. Time of anastomosis testing [ Time Frame: 0 to 600 minutes ]
    Time from the start of the anastomosis testing till the end

  6. Operation time [ Time Frame: 0 to 600 minutes ]
    Time from the start of the operation until the end of the operation

  7. 90 days mortality [ Time Frame: 0 to 90 days ]
    the mortality of the patients after the operation

  8. Timing of anastomosis leakage [ Time Frame: 0 to 60 days ]
    In days after surgery


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Contacts
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Contact: Marius Kyzauskas +37062214027 marius.kryzauskas@santa.lt
Contact: Tomas Poskus, prof. +37068678893 tomas.poskus@santa.lt

Locations
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Lithuania
National Cancer Institute, Vilnius, Lithuania Recruiting
Vilnius, Lithuania
Contact: Audrius Dulskas, PhD.    +37067520094    audrius.dulskas@nvi.lt   
Sub-Investigator: Justas Kuliavas         
Sub-Investigator: Rimantas Bausys         
Sub-Investigator: Eugenijus Stratilatovas         
Principal Investigator: Audrius Dulskas         
Vilnius University hospital Santaros klinikos Recruiting
Vilnius, Lithuania
Contact: Tomas Poskus    +37068678893    tomas.poskus@santa.lt   
Sub-Investigator: Marius Kryzauskas         
Sub-Investigator: Eligijus Poskus         
Sub-Investigator: Augustinas Bausys         
Sub-Investigator: Matas Jakubauskas         
Sub-Investigator: Ugne Imbrasaite         
Sub-Investigator: Gabija Makunaite         
Sub-Investigator: Kestutis Strupas         
Principal Investigator: Tomas Poskus         
Sponsors and Collaborators
Vilnius University
Vilnius University hospital Santaros klinikos, Vilnius, Lithuania
National Cancer Institute, Lithuania
Investigators
Layout table for investigator information
Principal Investigator: Eligijus Poskus, prof. Vilnius University, Vilnius, Lithuania
Tracking Information
First Submitted Date  ICMJE April 17, 2019
First Posted Date  ICMJE May 22, 2019
Last Update Posted Date November 13, 2019
Actual Study Start Date  ICMJE April 1, 2019
Estimated Primary Completion Date January 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 27, 2019) 		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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 18, 2019) 		Rate of anastomotic leakage [ Time Frame: 0 to 60 days ]
The number of patients, who had clinical or radiological anastomotic leakage
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 27, 2019)
  • Quality of life before and after the operation [ Time Frame: 0 to 60 days ]
    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 [ Time Frame: 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.
  • Reoperation rate [ Time Frame: 0 to 60 days ]
    Patients, who needed re-interventions
  • Intraoperative test leakage [ Time Frame: 0 to 600 minutes ]
    Leakage rate detected intraoperatively after anastomosis testing
  • Time of anastomosis testing [ Time Frame: 0 to 600 minutes ]
    Time from the start of the anastomosis testing till the end
  • Operation time [ Time Frame: 0 to 600 minutes ]
    Time from the start of the operation until the end of the operation
  • 90 days mortality [ Time Frame: 0 to 90 days ]
    the mortality of the patients after the operation
  • Timing of anastomosis leakage [ Time Frame: 0 to 60 days ]
    In days after surgery
Original Secondary Outcome Measures  ICMJE
 (submitted: May 18, 2019)
  • Quality of life before and after the operation [ Time Frame: 0 to 60 days ]
    Using low anterior resection syndrome score (the LARS score)
  • Quality of life before and after the operation [ Time Frame: 0 to 60 days ]
    Using QLQ-C30 questionnaire
  • Reoperation rate [ Time Frame: 0 to 60 days ]
    Patients, who needed re-interventions
  • Intraoperative test leakage [ Time Frame: 0 to 600 min ]
    Leakage rate detected intraoperatively after anastomosis testing
  • Time of anastomosis testing [ Time Frame: 0 to 600 min ]
    Time from the start of the anastomosis testing till the end
  • Operation time [ Time Frame: 0 to 600 min ]
    Time from the start of the operation until the end of the operation
  • 90 days mortality [ Time Frame: 0 to 90 days ]
    the mortality of the patients after the operation
  • Timing of anastomosis leakage [ Time Frame: 0 to 60 days ]
    In days after surgery
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Problem of Colorectal Anastomosis Safety
Official Title  ICMJE Problem of Safety of Anastomosis in Colorectal Surgery and Search for the Solutions
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Colorectal Cancer
  • Colorectal Carcinoma
  • Colorectal Neoplasms
  • Colorectal Adenocarcinoma
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: Comprehensive anastomotic testing

All patients undergo:

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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 18, 2019) 		30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 1, 2020
Estimated Primary Completion Date January 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Marius Kyzauskas +37062214027 marius.kryzauskas@santa.lt
Contact: Tomas Poskus, prof. +37068678893 tomas.poskus@santa.lt
Listed Location Countries  ICMJE Lithuania
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03958500
Other Study ID Numbers  ICMJE 2019/3-1116-608
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Marius Kryzauskas, Vilnius University
Study Sponsor  ICMJE Vilnius University
Collaborators  ICMJE
  • Vilnius University hospital Santaros klinikos, Vilnius, Lithuania
  • National Cancer Institute, Lithuania
Investigators  ICMJE
Principal Investigator: Eligijus Poskus, prof. Vilnius University, Vilnius, Lithuania
PRS Account Vilnius University
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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