Anastomotic Leakage, Colon Cancer, Resection, Treatment
Conditions
Brief summary
This international multicentre retrospective cohort study aims to research anastomotic leakage after colon cancer resection and has two main objectives: 1. To identify predictive factors associated with 90-day mortality and 90-day Clavien-Dindo grade 4-5 complications amongst patients who developed AL following colon cancer resection and to develop and validate a prediction model for predicting 90-day mortality as well as the co-primary composite endpoint Clavien-Dindo grade 4-5 complications. 2. To explore and compare the effectiveness of various treatment strategies for AL following colon cancer resection, considering patient, tumour, resection and leakage characteristics.
Interventions
OTHERDevelopment of a model for predicting 90-day mortality and to compare various treatment strategies for anastomotic leakage
The prediction model and comparison of various treatment strategies will be studies when the data is available for analysis.
Sponsors
Radboud University Medical Center
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aged 18 years or older; * Surgical resection for primary colon cancer (cT1-4b, N0-2, M0-1) with formation of a primary colonic anastomosis and with or without diverting stoma; * Postoperative AL defined as: any clinical, radiological or intraoperative signs of disrupted integrity of the anastomosis. This also includes suspected leaks with any degree of extraluminal air or fluid on CT, perianastomotic abscess, purulent peritonitis without clear anastomotic defect, or any other suspicious condition in which there is no ultimate macroscopic proof of disrupted anastomosis. * Regarding the type of colon cancer resection, the following patients will also fulfil the inclusion criteria: patients who underwent cytoreductive surgery (CRS) simultaneous with resection of the primary colon cancer with or without hyperthermic intraperitoneal chemotherapy (HIPEC), simultaneous ablations/resections of metastasis, multivisceral resection, emergency resection, patients diagnosed with perforated disease/peritumoral abscess or fistula, and acute obstructions.
Exclusion criteria
* Surgical resection for benign colon disease; * Recurrent colon cancer resection; * Any primary colon malignancy other than adenocarcinoma (e.g. neuroendocrine tumour, gastrointestinal stromal tumour); * Any clinical condition that does not fulfil the broad definition of AL as used in this study (e.g. only free air on CT that is considered to be compatible with an appropriate postoperative day in the absence of any other clinical signs related to a potential anastomotic leakage)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 90-day mortality | 90 days after colon cancer resection | mortality correlated with anastomotic leakage |
| 90-day Clavien-Dindo grade IV - V complications | 90 days after colon cancer resection | This composite co-primary outcome consists of single-organ failure (i.e. grade IV) and mortality (i.e. grade V) |
Secondary
| Measure | Time frame |
|---|---|
| Length of hospital/intensive care unit stay | at least one year follow up |
| Mortality | 30-day, 90-day and one-year after colon cancer resection |
| Time from colon cancer resection to diagnosis of anastomotic leakage | at least one year follow up |
| Disease status | At least one year after colon cancer resection, preferably at last date of follow up |
| Number of radiologic and surgical reinterventions | One year after colon cancer resection |
| Stoma presence (and if so, type of stoma) | At least one year after colon cancer resection, preferably last date of follow up |
| Time from colon cancer resection to primary treatment of anastomotic leakage | at least one year follow up |
Contacts
Primary ContactJobbe Lemmens, MD
Outcome results
None listed