The Problem of Colorectal Anastomosis Safety

Colorectal Cancer Clinical Trial

— ANSCRS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03958500
• Other study ID #: 2019/3-1116-608
• Status: Completed
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: January 31, 2022

Study information

• Verified date: May 2022
• Source: Vilnius University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 31, 2022
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Adenocarcinoma
• Colorectal Cancer
• Colorectal Carcinoma
• Colorectal Neoplasms

Intervention

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

Locations

Country	Name	City	State
Lithuania	National Cancer Institute, Vilnius, Lithuania	Vilnius
Lithuania	Vilnius University hospital Santaros klinikos	Vilnius

Sponsors (3)

Lead Sponsor	Collaborator
Vilnius University	National Cancer Institute, Lithuania, Vilnius University hospital Santaros klinikos, Vilnius, Lithuania

Country where clinical trial is conducted

Lithuania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Reoperation rate	Patients, who needed re-interventions	0 to 60 days
Secondary	Intraoperative test leakage	Leakage rate detected intraoperatively after anastomosis testing	0 to 600 minutes
Secondary	Time of anastomosis testing	Time from the start of the anastomosis testing till the end	0 to 600 minutes
Secondary	Operation time	Time from the start of the operation until the end of the operation	0 to 600 minutes
Secondary	90 days mortality	the mortality of the patients after the operation	0 to 90 days
Secondary	Timing of anastomosis leakage	In days after surgery	0 to 60 days

External Links

•   Protocol
•   Study results