Predictive Factors for Anastomotic Leakage After Colorectal Surgery: Study Protocol for a Prospective Observational Study (REVEAL Study).
BACKGROUND
Anastomotic leakage (AL) remains the most important complication following colorectal surgery, and is associated with high morbidity and mortality rates. Previous research has focused on identifying risk factors and potential biomarkers for AL, but the sensitivity of these tests remains poor.


OBJECTIVE
This prospective multicenter observational study aims at combining multiple parameters to establish a diagnostic algorithm for colorectal AL.


METHODS
This study aims to include 588 patients undergoing surgery for colorectal carcinoma. Patients will be eligible for inclusion when surgery includes the construction of a colorectal anastomosis. Patient characteristics will be collected upon consented inclusion, and buccal swabs, breath, stool, and blood samples will be obtained prior to surgery. These samples will allow for the collection of information regarding patients' inflammatory status, genetic predisposition, and intestinal microbiota. Additionally, breath and blood samples will be taken postoperatively and patients will be strictly observed during their in-hospital stay, and the period shortly thereafter.


RESULTS
This study has been open for inclusion since August 2015.


CONCLUSIONS
An estimated 8-10% of patients will develop AL following surgery, and they will be compared to non-leakage patients. The objectives of this study are twofold. The primary aim is to establish and validate a diagnostic algorithm for the pre-operative prediction of the risk of AL development using a combination of inflammatory, immune-related, and genetic parameters. Previously established risk factors and novel parameters will be incorporated into this algorithm, which will aid in the recognition of patients who are at risk for AL. Based on these results, recommendations can be made regarding the construction of an anastomosis or deviating stoma, and possible preventive strategies. Furthermore, we aim to develop a new algorithm for the post-operative diagnosis of AL at an earlier stage, which will positively reflect on short-term survival rates.


BACKGROUND
Clinicaltrials.gov: NCT02347735; https://clinicaltrials.gov/ct2/show/NCT02347735 (archived by WebCite at http://www.webcitation.org/6hm6rxCsA).
Department of General Surgery, Maastricht University Medical Centre, Maastricht, Netherlands. a.jongen@maastrichtuniversity.nl.
Audrey Chm
http://orcid.org/0000-0002-5743-5799
AC
Jongen
Joanna Wam
http://orcid.org/0000-0003-0668-9470
JW
Bosmans
Serdar
http://orcid.org/0000-0001-9150-7664
S
Kartal
Tim
http://orcid.org/0000-0002-4385-401X
T
Lubbers
Meindert
http://orcid.org/0000-0002-4848-138X
M
Sosef
Gerrit D
http://orcid.org/0000-0001-6910-9512
GD
Slooter
Jan H
http://orcid.org/0000-0003-3178-0049
JH
Stoot
Frederik-Jan
http://orcid.org/0000-0001-8111-8198
FJ
van Schooten
Nicole D
http://orcid.org/0000-0003-4070-8559
ND
Bouvy
Joep Pm
http://orcid.org/0000-0003-0694-7679
JP
Derikx
Anastomotic leakage; Biomarkers; Colorectal surgery; Personalized medicine; Postoperative complications