No registrations found.
ID
Source
Brief title
Health condition
Anastomotic leakage, colorectal surgery, drainage fluid, biomarkers
Naadlekkage, colorectale chirurgie, drainvocht
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measure of the APPEAL-study is anastomotic leakage, defined as an insufficiency of the anastomosis, demonstrated by either endoscopy, radiologic studies or operation and leading to a clinical state that requires an intervention. These interventions are:
a) Therapeutic drainage
b) Use of therapeutic antibiotics
c) Any surgical intervention, for example:
• Construction diverting stoma
• Construction new anastomosis
• Surgical disconnection of the
anastomosis
• Suturing
Secondary outcome
Comparison of the studied potential biomarkers in terms of speed, accuracy and cost-effectiveness
Study the capacity of the potential biomarkers to distinguish between clinically manifest and subclinical anastomotic leakage
Background summary
The main complication after colorectal surgery is anastomotic leakage (AL), with an incidence varying between 5% and 15%. In an insufficient anastomosis, wall defects can develop through which non-sterile contents of the colon can leak into the abdominal or pelvic cavity. This can cause severe infections that can lead to sepsis, multiple organ failure and death. Mortality rates are approximately 10% to 20%.
Observation of clinical signs and symptoms of AL, the current diagnostic tools, is not very specific. They can mimic several common, less severe, postoperative infections. Diagnostic tests for these infections can delay the actual diagnosis. On top of that, when AL has already progressed to a state of clinical manifestation, the patient is already ill and treatment should be initiated. Imaging modalities, more specific abdominal CT-scans and contrast enemas, are normally used to confirm a clinical diagnosis of AL (4). This means that imaging is done when the patient has already shown signs and symptoms and treatment has to be initiated. In short, it can be stated there is much need for an objective biomarker of AL.
An accepted method for prevention of complications of AL after colorectal surgery is prophylactic drainage. This enables postoperative evacuation of blood and wound fluid collections and therefore decreases the risk of infection. The aim of the APPEAL-study is to analyse these collections, retrieved from the drain’s reservoir, for potential biomarkers of AL in an early stage. Drainage fluid will be collected during 5 days. The fluid will be processed in the laboratory of microbiology, where a culture is done and the remaining fluid is centrifugated and frozen for later, in batch, analysis. The clinical chemical tests will be done in batch in the Erasmus MC. The cultures, centrifugation and freezing of the fluids will be done at the laboratory of microbiology of the participating medical center.
The results of the cultures and clinical chemical analyses will be known for the researcher, not for the patient and not for the medical doctors treating the patient. The results of the group with anastomotic leakage will be compared with the results of the group without anastomotic leakage in order to define one or more biomarkers.
Study objective
Drainage fluid of patients that received a primary colorectal anastomosis contains one or more biomarkers for anastomotic leakage that allow diagnosis of this complication in an early postoperative phase. The aim of this study is to identify these potential biomarkers.
Study design
Drainage fluid will be taken from the drain during the first 5 postoperative days.
During the first postoperative consultation after approximately one month the patient will be evaluated for signs of anastomotic leakage.
Analysis of drainage fluid will be done when a sufficient number of samples is collected for efficient analysis.
Intervention
Prophylactic drainage after colorectal surgery is common practice. When a drain is left behind during operation the patient can be included in the study. The only difference with routine practice is that the drain will stay in place until the fifth postoperative day, which is longer than in routine practice. When complications or discomfort occurs before this term the drain will be removed.
Dr. Molewaterplein 50
Erasmus MC
N. Komen
Rotterdam 3015 GE
The Netherlands
+31(0)10 7043683
n.komen@erasmusmc.nl
Dr. Molewaterplein 50
Erasmus MC
N. Komen
Rotterdam 3015 GE
The Netherlands
+31(0)10 7043683
n.komen@erasmusmc.nl
Inclusion criteria
1. All patients in which a drain has been
placed at the anastomotic site after one
of the following procedures:
- Left hemicolectomy
- Sigmoid resection
- Anterior resection (high & low)
- Total Mesorectal Excision
- Subtotal colectomy with ileo-
rectal or ileo-anal anastomosis
2. Informed consent
3. Primary anastomosis
Exclusion criteria
1. Pregnancy
2. Age < 18 years
3. Refusing to participate
4. Urgent operation
5. No drain
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 |
---|---|
NTR-new | NL1213 |
NTR-old | NTR1258 |
Other | MEC : 2006-183 |
ISRCTN | ISRCTN wordt niet meer aangevraagd |