Endo-SPONGE for treating low rectal anastomotic leak

Endo-SPONGE is a minimally invasive surgical treatment for anastomotic leak in the low rectal area. It consists of an open-pore sponge with a drain tube, a sponge pusher, silicon overtube guides and a drainage set and system. The system is designed to improve the clearance of leaking discharge in the anastomotic cavity and to promote granulation tissue formation and healing. Risks associated with Endo‑SPONGE include residual sponge particles left in the cavity, erosion of structures next to the sponge, injury to the intestinal wall and bleeding.

The sponge needs to be replaced every 2 to 3 days. The replacement sponge is cut to the size of the leaking cavity as it gets smaller and the drainage tube exits the body through the anus. The first insertion procedure is usually done in an operating theatre under general anaesthesia. The replacement procedures can be done in a day-case theatre or endoscopy suite under light sedation.

Endo‑SPONGE is an endoluminal vacuum therapy device. The sponge is inserted into the leaking cavity using a flexible endoscope or open access through the anus. A drainage tube is connected to the sponge at one end with a drainage bottle at the other end. The bottle has a low-vacuum drainage container that uses suction to put continuous negative pressure on the sponge.

Endo‑SPONGE is intended for people with an extraperitoneal rectal anastomotic leak. It is inserted by colorectal surgeons, endoscopists and gastroenterologists in hospital. The Endo‑SPONGE system is not suitable for the following conditions: malignant tumour wound, necrotic tissue or gangrene, untreated osteomyelitis, anastomotic leak directly adjacent to vessels, bladder or small bowel obstruction, non-drainable septic focus, systemic sepsis and clotting disorders.

NICE has not published guidelines on rectal anastomotic leak and the clinical experts said that there is no standard care pathway. The Association of Coloproctology of Great Britain and Ireland's (ACPGBI) guidance on the prevention, diagnosis and management of colorectal anastomotic leakage (March 2016) says that people with anastomotic leaks who are clinically stable may have conservative treatment using fluids, antibiotics and oxygen, with close clinical observation. But if people show signs of sepsis, the source of the leak must be removed within 3 to 18 hours, depending on the underlying condition and severity of infection. In less severe cases of sepsis associated with extraperitoneal rectal anastomotic leak, proximal defunctioning of the anastomosis with trans-anal or trans-peritoneal drainage may be considered. If there is radiological evidence that the anastomotic cavity is separate from the bowel, or if there are multiple sites of anastomotic leak, surgical intervention is needed.

The Endo‑SPONGE kit costs £250.20 (excluding VAT) for a single sponge. The company estimates that complete treatment with Endo‑SPONGE needs about 7 or 8 sponges. The drain bottle is bought separately, costing £20.90 per bottle (excluding VAT). Any glycerol-based hydrogel can be used and costs between £1 and £1.50 per tube.

For more details, see the website for Endo-SPONGE.