Endo-SPONGE for treating low rectal anastomotic leakage

Technology

2.1 Endo-SPONGE is a minimally invasive surgical treatment for anastomotic leakage 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 leakage 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 leakage 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.

Innovative aspects

2.2 Endo-SPONGE is a vacuum therapy. The sponge is inserted into the leakage 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.

Intended use

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

Relevant pathway

2.4 NICE has not published guidelines on rectal anastomotic leakage and the clinical experts noted that there is no standard care pathway for treatment. Guidance from the Association of Surgeons of Great Britain and Ireland on Prevention, Diagnosis and Management of Colorectal Anastomotic Leakage (March 2016) states that people with anastomotic leakage who are clinically stable may be treated conservatively using fluids, antibiotics and oxygen, with close clinical observation. However, for people showing signs of sepsis, steps must be taken to remove the source of the leak 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 leakage, 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 leakage, surgical intervention is needed.

Costs

2.5 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\u2011\SPONGE.