TreatmENT of AnastomotiC LeakagE After COLON Cancer Resection

Launched by RADBOUD UNIVERSITY MEDICAL CENTER · Jul 29, 2024

Keywords

ClinConnect Summary

This clinical trial is focused on understanding a complication called anastomotic leakage (AL) that can happen after surgery for colon cancer. When a surgeon removes part of the colon, they often need to reconnect the remaining pieces, which is called an anastomosis. Sometimes, this connection can leak, leading to serious health issues. The study has two main goals: first, to find out what factors might predict whether a patient will have serious complications or even die within 90 days after experiencing an anastomotic leak; and second, to compare different treatment options available for managing this complication.

To participate in this study, individuals must be at least 18 years old and have had surgery for primary colon cancer, which includes certain types of surgical procedures like those for advanced cancer or emergencies. Participants will be monitored to see how well different treatments work for them if they experience an anastomotic leak. This study is not yet recruiting participants, but it aims to gather important information that could help improve care for patients facing this challenging situation.

Gender

ALL

Eligibility criteria

• 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)