Experimentally, develop a software algorithm to objectively assess the microcirculation quality of the colorectal wall, intraoperative, by laparoscopy to predict the probability of developing anastomotic leakage, with the intention to develop a…
ID
Source
Brief title
Condition
- Gastrointestinal infections
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. The mean speckle contrast, intraoperative, of the colon or rectum in
patients, with 532nm and 660nm light, who have developed anastomotic leakage
2. The mean microcirculatory flow, intraoperative, of the colon or rectum in
patients, with 532nm and 660nm light, who have developed anastomotic leakage
3. The mean speckle contrast, intraoperative, of the colon or rectum in
patients, with 532nm and 660nm light, who have not developed anastomotic leakage
4. The mean microcirculatory flow, intraoperative, of the colon or rectum in
patients, with 532nm and 660nm light, who have not developed anastomotic leakage
All 4 primary parameters are measured during the folowing critical moments
during elected colorectal surgery:
a. Before vascular ligation (baseline):
b. At a reference, coecum or sigmoid (baseline)
c. After vascular ligation
d. After colon division at the proximal and distal stump
e. On the anastomosis
Secondary outcome
All other riskfactors related to anastomotic literature found in literature
Background summary
Anastomotic leakage (AL) is the commonest major complication in colorectal
surgery, the resection of a part or entire colon or rectum, due to the presence
of cancer or diverticulitis. The consequence of AL is that intestinal contents
(faeces) are entering the abdominal cavity, which can lead to peritonitis and
can result in the need for additional surgery, prolonged hospital stays,
increased morbidity and mortality and possibly a poorer oncological prognosis
in the postoperative period.
In literature, different percentages are published about the occurrence of AL
varying from 0.5%-30%, depending on the method of evaluation and location of
the anastomosis, with an associated 30-day mortality rate of 3%-22% with
subsequently a 10%-100% chance of permanent stoma. The current average AL rate
in The Netherlands is 11%.
The mean length of stay in the hospital for patients with anastomotic leakage
has been described between 36 and 39 days, approximately 4 times longer than
for patients without a leak. This prolonged hospital stay is caused by multiple
reoperations and stoma creation to control the leak, which significantly
increases health risks and healthcare costs up to 5 times that of patient
without a leak.
Study objective
Experimentally, develop a software algorithm to objectively assess the
microcirculation quality of the colorectal wall, intraoperative, by laparoscopy
to predict the probability of developing anastomotic leakage, with the
intention to develop a novel diagnostic device based on a laparoscopic laser
speckle contrast analysis (lapLASCA) technique.
Study design
The research is done during elected colorectal surgeries. At critical moments
during surgery, videos are captured with red (660nm) and green (532nm) light,
instead of the normally used white light. During each video a reference video
will be recorded of the coecum or sigmoid (dependent of the type of resection
surgery). These videos are stored and post-operatively processed with a
software algoritm (lapLASCA) for further analysis. The quality of the
microcirculation can be determined by contrast or flow differences,
intra-individual or over the population. In combination with other anastomotic
leakage risk factors, a analysis will be done to study the possibility to use
lapLASCA in a medical device to predict the probability of anastomotic leakage
occurrence, postoperative to colorectal surgery.
Study burden and risks
Patient risk will be minimal. Possible risks for the patients are prolonged
surgeries, caused by the videocapturing (>200 minutes is related to increased
risk for anastomotic leakage, 180 minutes is normally scheduled for these type
of surgeries). Air flow can be changed, caused by positioning of the research
equipment and/or more people in OR. This can increase the risk of developing
wound infections.
Henri Dunantweg 2
Leeuwarden 8934AD
NL
Henri Dunantweg 2
Leeuwarden 8934AD
NL
Listed location countries
Age
Inclusion criteria
- elected surgery
- right (extended) hemicolectomie
-transverse colectomy
- sigmoid colectomy
- (low) anterior rectal resection
- Hartmann reversal surgery
-Laparoscopic procedure
Exclusion criteria
* Elected for subtotal colectomy
* Elected for abdominoperineal resection
* Elected for temporary colostomy procedures
* Septic patients (anastomotic leakage)
* Emergency surgeries
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL47924.099.14 |