Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT03643523 |
| Other study ID # |
ALB-CIR |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 15, 2019 |
| Est. completion date |
December 31, 2019 |
Study information
| Verified date |
August 2018 |
| Source |
Corporacion Parc Tauli |
| Contact |
Mora Dr. Laura |
| Phone |
34639101033 |
| Email |
mora.lopez.laura[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Colorectal surgery has traditionally been associated with significant morbidity and prolonged
hospital stay. Overall complication rates have been reported to be 26-35%. Infectious
complications, in particular, represent a major cause of morbidity and mortality after
colorectal surgery. Postoperative intra-abdominal infections after colorectal surgery are
mainly due to anastomotic leakage. They occur in 5 to 15% of patients and carry a short term
mortality of around 20%. They also have a major impact on the outcome of surgery as they
prolong in hospital stay, increase treatment costs and worsen long-term survival in cancer
patients. If diagnosed early, they can be treated effectively and their impact on surgery
outcome is thus minimised.
There is a growing interest to find a biological marker useful for early detection of
anastomotic leak; such a marker could play a pivotal role in the modern fast-track multimodal
protocols, allowing safe and early discharge of patients after colorectal surgery.
Although C reactive protein (CRP) and procalcitonin (PCT) have been proposed as predictors
for adverse outcomes in colorectal surgery, they both display the critical limitations of
slow kinetics. Conversely, serum albumin (ALB) is a maintenance protein that is rapidly down
regulated by inflammatory signals. There some studies about the use of postoperative ALB drop
as a marker of predictor for clinical outcome. These studies are either retrospective or mix
patients with different types of surgical procedures performed.
This study aimed to test the hypotheses that early postoperative albumin drop can predict
anastomotic leaks and also can predict postoperative infectious complications earlier than
other biological markers.
Description:
Colorectal surgery (CS) has traditionally been associated with significant morbidity and
prolonged hospital stay 1,2. Overall complication rates have been reported to be
26-35%.3,4,5,6 Infectious complications represent a major cause of morbidity and mortality
after CS.6 Postoperative intra-abdominal infections after CS are mainly due to anastomotic
leak (AL).7,8 They occur in 5 to 15% of patients and carry a short term mortality of around
20%.3 They also have a major impact on the outcome of surgery as they prolong in-hospital
stay, increase treatment costs and worsen long-term survival in cancer patients.9,10,11 If
diagnosed early, they can be treated effectively and their impact on surgery outcome is thus
minimised.9 It is well-known that clinical features are not accurate predictors of AL in
gastrointestinal surgery. 12,13 The white blood cell count is an unreliable predictor of
either intra-abdominal infection or global postoperative infections. Routine imagine for the
detection of leaks is not cost-effective and carries the drawback of radiation. Is it
therefore essential to identify an early marker of infection, particularly in the era of
"fast track" or "enhanced recovery " surgery, in which patients are discharged from hospital
soon after operation, with the risk of intra-abdominal infection becoming evident after
discharge thus inducing readmissions and late management.14 Althouhg early diagnosis of AL is
a key point in reducing its clinical consequences in terms of morbidity and mortality,
currently, AL diagnosis is often late because of misdiagnosis of medical complications and
false-negative radiological examinations.15,16 Although C reactive protein (CRP) and
procalcitonin (PCT) have been proposed as predictors for adverse outcomes in CS, they both
display the critical limitations of slow kinetics.17,18,19 Conversely, serum albumin (ALB) is
a maintenance protein that is rapidly down regulated by inflammatory signals. , Preliminary
data suggested that ALB level rapidly dropped after surgery and correlated to outcomes in
oesophageal, oral cancer, abdominal20 pancreatic, liver resection /trasplant and cardiac
surgeries. However, prospective validation is missing, and ALB is not used to assess surgical
stress or to predict outcomes.
Protein metabolism is significantly disturbed after any kind of traumatic event, for example,
surgery, sepsis, and burn injuries , ALB has been identifyed as a reliable indicator of this
process.21 Plasma concentration of ALB reveal an important decrease as early as a few hours
after the hit.21,22,23 A previous studies estimated that 77% of the postoperative ALB
decrease was due to redistribution, while 18% and 6% were attributed to blood loss and
catabolism, respectively.24 Of note, transcapillary exchange rate early depended on the
underlying trauma and no increase was noted after minor surgery.25,26 After operation,
proinflamatory cytokines increase because of surgical stress, which leads to the reaction of
circulating acute phase proteins, such as CRP and inteleukin-6, which have been widely use to
predict complications after colorectal surgery.20 ALB, which is a marker of nutritional
status and a negative acute phase protein, decreases immediately after surgery because of the
physiological response to trauma. Increased capillary leakage of ALB is also one of the
features of the systemic inflammatory response to surgical stress, which leads to a decreased
level of plasma albumin. The response of ALB to surgical stress might occur earlier than CRP
because ALB has quick kinetics after surgery.
There some studies about the use of postoperative ALB drop as a marker of predictor for
clinical outcome. The first one, Hübner and col.21 shows a prospective pilot study about 70
patients undergoing frequent abdominal procedures of different magnitude. They measured ALB,
CRP and CPT once daily starting the day before surgery until postoperative day (POD) 5. The
conclusion of the estudy was that early postoperative ALB drop appeared to reflect the
magnitud of surgical trauma and was correlated with adverse clinical outcomes. The group
continues the same line of work and publishes another prospective cohort study with 138
patients undergoing major abdominal surgery. They collect blood samples before and on POD
0,1,2 and 3. They compare ALB decrease and CPR and CPT. The postoperative outcomes of the
study were complications and length of hospital stay. They found a decrease of ALB of 10%
yielded a sensitivity of 77.1% and a specificity of 67.2% (AUC : 78.3%) to predict
complications. On the other hand, they also found that decrease of ALB of 10% on POD1 showed
a threefold increased risk of overall postoperative complications.21 Antoher group, Ge et
al.27 made a retrospective study about 626 patients undergoing major colorectal surgery with
the main outcome were to identify risk factors for postoperative complications and to
identify the factors associated with the ALB decrease. This study revealed the patients with
a greater relative decrease in serum ALB in POD 2 were at higher risk of postoperative
complications, prolonged postoperative hospital stays, an more Surgical Site infeccions after
colorectal surgery. A cutoff value of 15% reduction in serum ALB on POD 2 distinguished
patients at low risk and high risk for postoperative complications in an earlier stage and
was more accurate the CRP level on POD 3 and 4.
These are the preliminary data that lead us to start our study in order to demonstrate the
utility of the postoperative decrease of serum albumin as an early detector of anastomotic
leak and infectious complications in patients undergoing major colorectal surgery This study
aimed to test the hypotheses that early postoperative albumin drop can predict anastomotic
leaks and also can predict postoperative infectious complications earlier than other
biological markers
