Validate the presence and correlation of intraoperative modifiable risk factors for colorectal seam leaks.
ID
Source
Brief title
Condition
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main parameter is the amount of present intraoperative risk factors for CAL:
1 hemoglobin level,
2 glucose level,
3 subjective assessment of contamination of the operating field,
4 inotropic support,
5 timing of preoperative antibiotics,
6 administration of epidural,
7 operating time
8 temperature
Secondary outcome
1. Reduction of CAL by enhanced validation
2. Confirm the association between the intraoperative risk factors with CAL
Background summary
Colorectal anastomotic leakage (CAL)
In colorectal surgery the only alternative for a stoma is a colorectal
anastomosis by reconnecting the two ends of intestine.1 The problem of this
procedure is leakage of the attachment2. The consequences of an anastomotic
leak are well known amongst surgeons. Symptoms such as abdominal pain,
palpitations, fever and a bloated abdomen along with characteristic blood
tests, are indicative for urgent surgical re-intervention3. The surgery area
needs to be washed out and a fecal diversion is necessary otherwise
gastrointestinal contents can cause further complications. This is associated
with a prolonged stay in the intensive care unit, and a mortality rate of
approximately 10% to 15%4. In addition, a leakage has been associated with an
increased local relapse and a reduced long term survival after colorectal
cancer surgery5,6. The 30-day mortality as well as the readmission rate and
Length Of hospital Stay (LOS) rises substantially with CAL, thereby increasing
the treatment costs.
Colorectal anastomotic leakage is an important topic in scientific research due
to the severe consequences. A number of anastomotic studies resulted in a
decline of leakage. Nevertheless, CAL remains a surgeons most feared
complication with an incidence varying from 8-13%7*10. Main research focus has
been directed towards optimization of surgical techniques and determining
relevant risk factors.7 Previous studies have revealed that patient-related
factors, such as male gender and higher American Society of Anesthesiologist
(ASA) score, are associated with CAL.4,10-13 Some of them have been included
in a colon leakage score (CLS) to determine in advance whether an anastomosis
or stoma should be constructed17,18. The downside of this score is that after
determining a high CAL-risk, there is no possibility to change or improve the
risk factors. There are pre-habilitation programs that improve the patient's
preoperative status, focusing on the risk factors related to the patient*s
lifestyle19. But also, an optimal surgical environment proves to have a
beneficial effect on the healing of the anastomosis22,23. For instance,
anesthesiological/hemodynamic parameters were revealed to be related to the
risk of insufficient anastomotic healing, perfusion and ischemia. Previous
international research by our research group showed seven risk factors for CAL
that can be optimized in the perioperative setting.32 Their distribution
amongst the study population is shown in figure 1. These are the following
seven intraoperative risk factors for CAL; low preoperative hemoglobin (OR
5.21,p<0.001), fecal contamination of the operative field (OR 3.14,p<0.001),
hyperglycemia (OR 3.05,p=0.002), duration of surgery of more than 3 hours (OR
1.83,p=0.014), inotropic support (OR 1.78,p=0.010), inadequate timing of
preoperative antibiotic prophylaxis (OR 1.57,p=0.047) and application of
epidural analgesia (OR, 1.75,p=0. 014).32 These are modifiable intraoperative
factors that are able to be optimized. These parameters are not currently being
explicitly monitored or optimized during the operation, or, in particular,
while making the anastomosis. Additionally, optimal values or guidelines for
optimization for these modifiable risk factors are not established.
While a study is currently being designed to investigate whether optimization
leads to decrease in incidence of CAL. The aim of this multicenter prospective
cohort study is enhanced validation of these modifiable risk factors for CAL.
Repeated emphasis of the importance of intraoperative risk factors could
potentially automatically lead to a reduction in abnormalities, the phenomenon
known as the Hawthorne effect. By raising awareness around important risk
factors this could lead to a possible reduction of CAL.
Study objective
Validate the presence and correlation of intraoperative modifiable risk factors
for colorectal seam leaks.
Study design
A prospective multi center cohort study.
Study burden and risks
There are no risks or additional burden.
loosduinenstraat 92
AMSTERDAM 1062 EG
NL
loosduinenstraat 92
AMSTERDAM 1062 EG
NL
Listed location countries
Age
Inclusion criteria
* Subjects undergoing colorectal surgery with any kind of anastomosis.
* Can speak and understand the Dutch language.
* Is pre-operatively in good physical health as defined by ASA (American
Society ` of Anaesthesiologists) physical status classification system 1, 2 and
3.
* Is capable of giving informed consent.
Exclusion criteria
- No exclusion criteria.
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 | NL71966.029.19 |