Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04766060 |
| Other study ID # |
PLarsen |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
April 1, 2017 |
| Est. completion date |
November 30, 2018 |
Study information
| Verified date |
February 2021 |
| Source |
Odense University Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
A serious complication to colorectal surgery is anastomotic leakage (AL). AL increases
post-operative mortality, decreases long-term survival, reduces the functional result and
reduces qual-ity of life. Studies suggest that performing an indocyanine-green enhanced
fluorescent angi-ography (ICGeFA), blood perfusion in the bowel can be visualised. It is
suggested that using this procedure the relative risk of AL is reduced about 54-67%.
With this project we wish to evaluate the feasibility of the procedure, and, if proven
feasible, to plan further studies evaluating the procedure.
Description:
Colorectal cancer is one of the most common cancer-diagnosis in Denmark. In 2014, 5186
pa-tients with colorectal cancer were registered. 1674 patients had cancer in the rectum and
1316 in the sigmoid colon. 668 patients underwent surgery with low anterior resection (LAR)
and primary anastomosis, and 850 patients had a sigmoid resection with primary anastomosis.
A serious complication is anastomotic leakage (AL). In 2014 a total of 67 (10%) patients were
registered with AL.
In general AL increases the post-operative mortality, decreases long-term survival and
reduces the functional result and thereby reduces quality of life.
Due to the possible severity of AL all measures possible should be taken to ensure an early
diag-nosis and timely treatment, as this has been shown to reduce morbidity and mortality.
The symp-toms of AL are uncharacteristic; the diagnosis cannot only rely on the development
of clinical symptoms. However, specific clinical scoring symptoms, measuring C-reactive
protein (CRP) and radiologic examinations are proven useful.
Treatment of AL varies with the degree of leakage, from conservative treatment with rectal
lavage, endo-VAC therapy, drainage of abscesses, re-laparoscopy or laparotomy with a
diverting stoma, and finally to break down the anastomosis and creating a temporary or
permanent colostomy, all procedures with or without antibiotic treatment.
It is essential that surgeons continuously strive to improve the operative technique with
regard to anastomosis construction. Many factors influence the anastomotic healing:
instrumentation error, tension on the anastomosis, bacterial contamination, etc. An important
factor to ensure most opti-mal conditions in anastomotic healing is to ensure sufficient
blood-supply/oxygen tension.
The surgeon evaluate so-called surrogates of bowel perfusion (evaluation of colour,
mesenteric pulsation and arterial bleeding) prior to form the anastomosis, but studies have
demonstrated that surgeon's intraoperative judgment in predicting of anastomotic leakage AL
has an extremely low sensitivity and specificity.
Studies suggest that performing an indocyanine-green enhanced fluorescent angiography
(ICGeFA), the blood perfusion in the bowel can be visualised. It is suggested that by
evaluating perfusion of bowel ends, and, if needed, doing a re-resection, the risk of
anastomotic leakage can be diminished. It is suggested that evaluating the anastomosis with
ICG-FA and revising the anas-tomosis if necessary, the relative risk reduction of AL is about
54-67%. Several studies in robotic and laparoscopic colorectal surgery, confirms feasibility
of using ICGeFA, also showing promising results in evaluating the bowel perfusion. Most
studies and a newly published systematic review conclude that there is great need for larger
controlled studies or randomised trails.
The primary objective with this study is to evaluate the feasibility of using ICGeFA in
colorectal surgery and to evaluate if the surgeon's interpretation is dose and time
dependent. Secondary ob-jective is to establish a nationwide research team, joining all the
Robotic Surgery Centres in Den-mark for future research.
Last we wish to identify the optimal design for a further study, evaluating whether ICG is a
helpful tool in diminishing the risk of anastomotic leakage.
