Primary objective:To find a relation between several laboratory test, clinical parameters and riskfactors to the occurrence of anastomotic leakage after a colectomy, esophagectomy or gastrectomy.Secondary objective:To find a combination of factors…
ID
Source
Brief title
Condition
- Procedural related injuries and complications NEC
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The following serum blood values will be measured and their relationship with
anastomotic leakage will be analyzed between patients with anastomotic leakage
and control patients without anastomotic leakage.
* Leucocyte count and differentiation
* C-reactive protein
* Procalcitonin
* Lactate
* Creatinin
The outcome of the study is the occurrence of anastomotic leakage confirmed by
CT, water soluble enema, explorative surgery or pathology within 28 days after
initial surgery.
Secondary outcome
In addition, the following clinical parameters and patient characteristics
will be recorded and compared between patients with anastomotic leakage and
control patients without anastomotic leakage.
* Age
* Gender
* American Society of Anesthesiologists (ASA) classification
* Body mass index (BMI)
* Intoxication (smoking, alcohol, drugs)
* Malnutrition universal screening tool (MUST) score
* Systemic steroid or Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) use in the
last 4 weeks
* Diabetes mellitus
* Cardiac comorbidity
* Pulmonary comorbidity
* Neoadjuvant therapy
* Laparoscopy or open
* Distance of anastomosis to anal verge
* Protective stoma
* Additional procedures
* Peroperative blood loss
* Number of peroperative blood transfusions
* Duration of operation
* Severity of peritonitis as scored by operating surgeon on a 1-5 scale
* Quality of anastomosis as scored by operating surgeon on an 1-5 scale
* Need for and duration of mechanical ventilation or oxygen support
* Need for inotropic drugs.
* Patient wellness scored on a three-point scale by the physician
* Duration of hospital admission
If possible, together with the results of the laboratory tests, these
parameters will be combined into a score to early detect anastomotic leakage in
future patients.
Background summary
Anastomotic leakage is a major and not uncommon complication in
gastro-intestinal surgery. The incidence ranges from 2 * 19% for colon
resections, around 11 * 20% for esophagus resections and 5 * 8% for gastric
resections. These account for substantial mortality and morbidity. To decrease
mortality, early detection and intervention is effective. However, early
detection of anastomotic leakage may be difficult since symptoms can
sub-clinical until major complications develop. Most are detected five to seven
days postoperatively or even later. Computer tomography (CT) as well as water
soluble enema are both good diagnostics for detection of anastomotic leaks but
the timing of use of these highly depends on the surgeon*s clinical suspicion.
This calls for the need of early indicators of anastomotic leakage which can
provide a useful tool to help surgeons detect high risk patients in an early
stage and continue to additional diagnostics or surgical intervention. As of
this moment, no reliable indicators have been found. Some studies have found
markers that are related to anastomotic leakage such as leucocyte count,
creatinin and C-reactive protein (CRP) as well as clinical parameters as fever
and pulmonary symptoms. However, these lack the sensitivity and specificity for
proper decision making. This study will analyse multiple standard laboratory
tests and clinical parameters in relation to anastomotic leakage after
colectomy, esophagectomy or gastrectomy. Each parameter/test will be analysed
separately as well as in combination with other parameters/tests. In addition,
there will be searched for a combination of factors that can reliably predict
and/or exclude anastomotic leakage to lower the number of unnecessary operation
and CTs.
Study objective
Primary objective:
To find a relation between several laboratory test, clinical parameters and
riskfactors to the occurrence of anastomotic leakage after a colectomy,
esophagectomy or gastrectomy.
Secondary objective:
To find a combination of factors to assess the likelihood of anastomotic
leakage in order to reduce the number of negative CT-scans and reoperations.
Study design
Prospective observational study.
Study burden and risks
The burden for included patients will be minimal since this will only include 5
venapunctures which in the majority of cases will be part of standard medical
care. In addition patients will be contacted 28 days after inclusion for some
short questions which will take a maximum of 10 minutes.
The following risks/complications are associated with the venapunctures:
- hematoma
- bleeding
- pain
These complications have a very small risk of causing permanent
damage/complaints to the patient.
Hoenderstraat 21 B
Maastricht 6211 EL
NL
Hoenderstraat 21 B
Maastricht 6211 EL
NL
Listed location countries
Age
Inclusion criteria
Patients who will undergo one of the following types of surgery will be included:
- (partial) colectomy with a primary anastomosis
- esophagectomy with gastric interposition
- (partial) gastrectomy
Exclusion criteria
Previous gastro-intestinal surgery in the last 2 months.
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 | NL40556.096.12 |