Introduction: Anastomotic leakage (AL) is the most severe complication following colorectal surgery and is associated with significant morbidity and mortality. VacStent therapy is a promising therapeutic approach, combining endoscopic vacuum therapy with mechanical stability of a stent and thereby allowing continued fecal passage. It may enhance anastomotic healing and reduce the need for a diverting ostomy or additional surgical procedures. VACStent Use for the treatment of anastomotic leakage following coloREctal surgery (VACURE) study aims to assess the efficacy and safety of VacStent therapy for colorectal AL.
Methods and analysis: VACURE is a prospective, multicenter efficacy study conducted at ten Dutch hospitals. Forty patients will be included over 18 months. All patients (≥18 years) with AL of the distal sigmoid, upper or mid rectum following colorectal resection will be considered for treatment with the VacStent GI Colon device. Trained endoscopists will perform stent placement, exchanges, and removal. Patients will remain hospitalized and those without diverting ostomy will receive osmotic laxatives and a fiber-free diet during treatment. Anastomotic healing will be confirmed endoscopically and radiologically posttreatment. The primary endpoint is the primary endpoint is the rate of participants that achieve complete anastomotic healing without the need for further interventions (confirmed by radiologic and endoscopic assessment). Secondary endpoints include safety, percentage of functioning anastomoses at 1 year post-treatment, 1-year stoma-free survival, diverting ostomy omission, healing time, number of stents, complications, reinterventions, length of hospitalization, pain scores, functional and quality of life outcomes up to 1 year posttreatment, patient experiences, and cost-effectiveness.
AL in the distal sigmoid, upper or mid rectum following a colorectal resection
≥ 18 years old.
Signed a written informed consent
Anastomosis that is not endoscopically accessible.
Contra-indications for VacStent GI therapy: (a) Significant tissue ischemia in the area of the wound cavity, larger than the length of the VacStent GI Colon; (b) Anastomotic defect located <4 cm from the dentate line. This is considered a relative contraindication, as very distal placement may cause patient discomfort although not necessarily; (c) Severe coagulopathy; (d) Ileus that does not allow for endoscopic examination.
Anastomotic fistula to surrounding organs (vagina, bladder, small bowel)
Single group
VacStent GI Colon device
DeviceThe VacStent GI Colon device (VacStent GI, VACStent GmbH, Fulda, Germany) is designed to treat colorectal AL and allows continued fecal passage through the stent. By combining the advantages of endoscopic vacuum therapy (EVT) with the mechanical stability of a stent, it promotes wound healing while maintaining luminal patency.
Successful VacStent treatment
The proportion of patients successfully treated with the VacStent GI Colon device for colorectal AL. Successful treatment is defined by: the proportion of patients with complete healed anastomoses, confirmed by endoscopic assessment at two weeks posttreatment and radiologic assessment at 6 weeks posttreatment, without the need for further interventions.
Safety profile: AE's and SAE's
Safety is defined as the occurrence of a maximum of one complication related to VacStent treatment, during VacStent treatment or within one day after removal of the VacStent, as defined by the AGREE classification grade 2 or higher. Grade 2: * Adverse events requiring pharmacologic treatment with drugs other than those allowed for grade 1 adverse events (ie, antibiot-ics, antithrombotics, etc.) or * Blood or blood product transfusions Grade 3: adverse events requiring endoscopic, radiologic, or surgical in-tervention * Grade 3a: endoscopic or radiologic intervention * Grade 3b: adverse events requiring intensive care unit/critical care unit admission Grade 4: adverse events requiring intensive care unit/critical care unit admission * Grade 4a: single-organ dysfunction (including dialysis) * Grade 4b: multiorgan dysfunction Grade 5: death of the patient
1-year stoma free-survival
Proportion of patients without a stoma
Temporary/permanent stoma
Proportion of patients with a temporary/permanent stoma
VacStent as sole therapy
Proportion of patients treated with VacStent as sole therapy
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
