Between July 2006 and April 2008, a series of patients with a presacral cavity after anastomotic leakage were treated by using the endo-sponge. All hospitals that had used the endo-sponge were contacted to collect data of experience with the endo-sponge. The endo-sponge had been used in patients following anastomotic leakage after low anterior resections for malignant disease or after restorative proctocolectomy with ileoanal pouch anastomosis for ulcerative colitis.
After surgery, when anastomotic leakage was suspected a computed tomography (CT) scan was performed in the majority of the cases. Using flexible endoscopy, the presence of an abscess cavity was confirmed. Subsequently a diverting stoma was routinely constructed when this had not been done during the primary operation. Primary outcome parameters were closure of the cavity and the ability to close the ileostomy. Factors associated with successful closure were analyzed, e.g., time of initiation of endo-sponge treatment after surgery, and experience with endo-sponge treatment (number of cases treated).
Approval of the Medical Ethics Committees was not necessary, since in the Netherlands for nonexperimental clinical case series such as this approval is not required.