Colorectal anastomotic leakage
Conditions
Interventions
The CE-marked VacStent GI Colon (VacStent GI™, VACStent GmbH, Fulda, Germany) will be used to facilitate anastomotic healing. 
Sponsors
Amsterdam UMC
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Anastomotic leakage in the distal sigmoid, upper or mid rectum following a colorectal resection.= 18 years old.Signed written informed consent.
Exclusion criteria
Exclusion criteria: Anastomosis that is not endoscopically accessible.Contra-indications for VacStent GI therapySignificant tissue ischemia in the area of the wound cavity, larger than the length of the VacStent GI Colon.Anastomotic defect located <4 cm from the dentate line. This is a relative contraindication, as very distal placement may cause patient discomfort, although not necessarily.Severe coagulopathy Ileus that does not allow for endoscopic examinationAnastomotic fistula to surrounding organs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage of participants that achieve complete anastomotic healing following VacStent therapy without the need for further interventions (confirmed by endoscopy 2 weeks after finishing vacstent therapy and CT scan 6 weeks after finishing vacstent therapy) | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety outcomes (AE/SAE rates), 1-year stoma-free survival, functioning stoma rates 1 year posttreatment, percentage of AL treatments without diverting ileostomy, time to healing of the anastomotic defect, number of reinterventions, duration of hospital stay, functional and quality of life outcomes, cost analysis of VacStent therapy. | — |
Countries
Netherlands
Contacts
Public ContactZ Weerts
Amsterdam UMC
Outcome results
None listed