The Problem of Colorectal Anastomosis Safety
ANSCRS
Problem of Safety of Anastomosis in Colorectal Surgery and Search for the Solutions
1 other identifier
interventional
60
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable colorectal-cancer
Started Apr 2019
Typical duration for not_applicable colorectal-cancer
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2019
CompletedFirst Submitted
Initial submission to the registry
April 17, 2019
CompletedFirst Posted
Study publicly available on registry
May 22, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2022
CompletedJune 3, 2022
May 1, 2022
2.8 years
April 17, 2019
May 31, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (8)
Quality of life before and after the operation
0 to 60 days
Quality of life before and after the operation
0 to 60 days
Reoperation rate
0 to 60 days
Intraoperative test leakage
0 to 600 minutes
Time of anastomosis testing
0 to 600 minutes
- +3 more secondary outcomes
Study Arms (1)
Comprehensive anastomotic testing
EXPERIMENTALAll patients undergo: 1. Indocyanine green fluorescent angiography intraluminally and intraperitoneally 2. Air leak test 3. Methylene blue test
Interventions
The use of indocyanine green fluorescent angiography to check bowel and anastomosis viability in standard low anterior rectal anastomosis
Eligibility Criteria
You may qualify if:
- patients over 18 year
- signed written consent
- a colorectal anastomosis lower 15 cm from anal verge
- elective surgery
You may not qualify if:
- allergy to indocyanine green dye
- pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
National Cancer Institute, Vilnius, Lithuania
Vilnius, Lithuania
Vilnius University hospital Santaros klinikos
Vilnius, Lithuania
Related Publications (1)
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.
PMID: 31914032DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eligijus Poskus, prof.
Vilnius University, Vilnius, Lithuania
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
April 17, 2019
First Posted
May 22, 2019
Study Start
April 1, 2019
Primary Completion
December 30, 2021
Study Completion
January 31, 2022
Last Updated
June 3, 2022
Record last verified: 2022-05