Endo-SPONGE for Treatment of Anastomotic or Hartmann's Stump Leakages in Lower Pelvic Area

This study is evaluating a minimally invasive treatment called Endoscopic Vacuum Therapy (EVT) using a device called Endo-SPONGE for patients who develop a leak at the site of a bowel reconnection (anastomotic leak) or a stump leak after colorectal surgery. An anastomotic leak is a serious complication where the surgical join in the bowel does not heal properly, leading to infection and requiring further treatment. Adults who have a confirmed grade B leak with a defect of at least 2 cm in the lower pelvic area after colorectal surgery, already have a diverting stoma, and are suitable for endoscopic treatment are eligible — those who have already tried this therapy or had surgery more than 60 days ago are not eligible. Participation involves placement of the Endo-SPONGE device via endoscopy (a tube with a camera through the bowel), with regular device changes over the healing period and follow-up visits. This summary was prepared with AI assistance to help patients understand the study in plain language.