| Objective: |
Design
The C-seal trial is a prospective multi-center randomized controlled trial, initiated by the department of surgery, division of abdominal surgery of the UMCG, the Netherlands. The study will be performed in approximately 35 clinics.
In this trial 616 patients will be randomized equally between the C-seal group and the control group. The study protocol is approved by the central medical ethics committee of the UMCG. In all participating centers a local feasibility agreement is arranged. Patients will be followed until one year after randomization.
Participants
Eligible patients are diagnosed with any colorectal disease requiring a colorectal anastomosis in an elective setting, have a minimum age of 18 years and an ASA classification re adequately trained in the application of the C-seal.
Intervention
Fifty percent of the study population will be randomized to the C-seal group and 50% to the control group. The C-seal is stapled to the anastomosis with a circular stapler. Before creating the anastomosis the C-seal is attached to the anvil of the circular stapler (Figure 1) and together they are inserted in the proximal bowel loop. After firing the circular stapler the C-seal is stapled to the mucosal side of the afferent loop (Figure 2). When the stapler is removed from the anus, the C-seal is brought through the anus and cut from the stapler anvil. The application of the C-seal to the anvil is trained in a practicum session provided to the participating operating surgeons and local research group.
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| Aim: |
OBJECTIVE: To evaluate the efficacy of the C-seal in reducing anastomotic leakage in stapled
colorectal anastomoses, as assessed by anastomotic leakage leading to invasive treatment within
30 days postoperative.
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| Methods: |
METHODS: The C-seal trial is a prospective multi-center randomized controlled trial with primary endpoint anastomotic leakage leading to re-intervention within 30 days after operation. In this trial 616 patients will be randomized to the C-seal or control group (1:1), stratified by center, anastomotic height (proximal or distal of peritoneal reflection) and the intention to create a temporary defunctioning stoma. Interim analyses are planned after 50% and 75% of patient inclusion. Patients at least 18 years of age with any colorectal disease requiring a colorectal anastomosis to be made with a circular stapler in an elective setting, with an American Society of Anesthesiologists classification |
| Reason for International Trial: |
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