TreatmENT of AnastomotiC LeakagE After COLON Cancer Resection
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRadboud University Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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)
Trial population
Adult patients who developed AL after surgical resection with formation of primary anastomosis for colon cancer (cT1-4bN0-2M0-1).
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Development of a model for predicting 90-day mortality and to compare various treatment strategies for anastomotic leakage
Other interventionThe prediction model and comparison of various treatment strategies will be studies when the data is available for analysis.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
90-day mortality
mortality correlated with anastomotic leakage
Time frame
90 days after colon cancer resection2
90-day Clavien-Dindo grade IV - V complications
This composite co-primary outcome consists of single-organ failure (i.e. grade IV) and mortality (i.e. grade V)
Time frame
90 days after colon cancer resectionSecondary outcomes
1
Time from colon cancer resection to diagnosis of anastomotic leakage
Time frame
at least one year follow up2
Time from colon cancer resection to primary treatment of anastomotic leakage
Time frame
at least one year follow up3
Length of hospital/intensive care unit stay
Time frame
at least one year follow up4
Mortality
Time frame
30-day, 90-day and one-year after colon cancer resectionLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: