ObjectiveTo identify biomarkers for CAL in drain fluid and serum, in addition to RT-PCR for E. faecalis, that increase specificity and positive predictive value.
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
- Gastrointestinal therapeutic procedures
Synonym
Research involving
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.
Secondary outcome
Not applicable
Background summary
The most important and frustating complication of colorectal surgery is
colorectal anastomotic leakage (CAL). The incidence of CAL varies from 3% and
19% and mortality rate due to CAL vary between 10% and 20%. To date, CAL is
suspected when certain signs and symptoms are present and confirmation occurs
by imaging and/or reoperation. CAL is generally confirmed six days to two weeks
after the operation at which point the patient is very ill. In order to reduce
the mortality and morbidity rates, it is necessary to confirm the diagnosis of
CAL before clinical signs and symptoms occur.
Study objective
Objective
To identify biomarkers for CAL in drain fluid and serum, in addition to RT-PCR
for E. faecalis, that increase specificity and positive predictive value.
Study design
To achieve the objective all included patients receive a drain that will be
removed at the third postoperative day. During this period drain fluid will be
retrieved daily and a blood examination, including CRP, will be performed as
well.
Drain fluid is collected daily, on postoperative day one to three, centrifuged
and stored at * 80 °C. Analysis will be performed in batch and, based upon
literature, consist of following groups of parameters:
* Bacteria: E. faecalis
* Immune-modulating parameters: IL-1, IL-6, IL-10 and TNF-*
* Pancreas enzymes: Amylase
* Tissue repair modulating parameters: MMP * 2 en MMP - 9
* Inflammatory parameters: LBP
* Metabolic parameters: Lactate, glucose, pH
Blood samples will be analysed for CRP.
Study burden and risks
Participation in this study provides no benefits to the patient. The load in
the context of the study will consist of invasive procedures to obtain
additional body material. The hospitalisation of the patients in this study
will not be prolonged. A drain is placed during operation which will remain in
place for 3 days. Normally, the operator decides during the operation if it is
necessary to place a drain. However, there are no clear guidelines for this
decision. A drain is placed more frequently in open surgery compared to
laparoscopic surgery. A drain could prevent complications after surgery.
However, there are also disadvantages to a drain.
- The drain may cause pain at the level of the skin
- While walking you should take the drain.
In addition, blood samples are taken at the three postoperative days. In
general there is no blood taken at the second postoperative day. The collection
of blood does have some risks for some patients. There is a risk of developing
a hematoma and it is possible to have a bleeding. However, the occurence of a
bleeding is stronly related to coagulation disorders.
Herestraat 49
Leuven 3000
BE
Herestraat 49
Leuven 3000
BE
Listed location countries
Age
Inclusion criteria
- Informed consent
- Primary anastomosis
- All patients with a postoperative drain at the anastomotic site after one of the following procedures:
* Total Mesorectal Excision (TME)
* Partial Mesorectal Excision (PME)
* Anterior resection with construction of a colorectal or colo-anal anastomosis
Exclusion criteria
- Pregnancy
- Age < 18 years
- No informed consent
- No drain
- Emergency surgery
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 | NL52251.078.15 |