The technology

Endo-SPONGE (B. Braun) is a vacuum therapy, consisting of an open-pored polyurethane foam sponge inserted into the leakage cavity using a flexible endoscope. A drainage tube is connected to the sponge at 1 end. This leaves the body through the anus and is connected to a low-vacuum wound drainage system. The suction gives continuous drainage and avoids a build-up of secretion in the cavity. Secretions are drained into a Redyrob transplus bottle (B. Braun). The company claims the negative pressure leads to granulation of the tissues in contact with the sponge. Depending on the size of leakage cavity, up to 3 sponges may be placed into the cavity. The sponge is changed every 24 to 72 hours and is cut smaller with every application where the size of the cavity has reduced. The company claim that an average of 7 to 8 sponges are needed to complete treatment. Light sedation and analgesia may be needed for the procedure. It may be necessary to use an endoscopic dilation balloon to widen the entrance to the anastomotic cavity so that the Endo‑SPONGE can be inserted.

Innovations

Endo-SPONGE is the only technology available that uses vacuum therapy to treat anastomotic leakage. An anastomotic leak is defined as a leak of luminal contents from a surgical join. Non-surgical treatment options for anastomotic leakage are limited and Endo-SPONGE is a minimally invasive endoscopic treatment. The company claims that using Endo-SPONGE reduces the risk of infection and over time reduces the size of the anastomotic cavity, through granulation of tissue caused by negative pressure, until it is healed. The company claims that if the area is already infected, Endo-SPONGE can be used to rapidly control the infection through active drainage. Endo-SPONGE can also be used to treat oesophageal leakages and perforations, however, the focus of this medtech innovation briefing is on colorectal anastomotic leakages only.

Current care pathway

NICE has not published guidelines on the treatment of colorectal anastomotic leakage. Guidance on prevention, diagnosis and management of colorectal anastomotic leakage from the Association of Surgeons of Great Britain and Ireland states that people with anastomotic leakage who are considered 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 transanal or transperitoneal 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.

The guidance mentions that the Endo-SPONGE technology may be an effective treatment for low rectal anastomotic leakages but that evaluation of clinical and cost benefits of using the technology is needed.

The following publications have been identified as relevant to this care pathway: Association of Coloproctology of Great Britain and Ireland, prevention, diagnosis and management of colorectal anastomotic leakage report (March 2016).

Population, setting and intended user

Endo-SPONGE is intended for people with extraperitoneal rectal anastomotic leakage after colorectal surgery. The technology is intended for use in a hospital setting and will be used by colorectal surgeons, endoscopists and gastroenterologists.

Costs

Technology costs

The Endo-SPONGE kit costs £250.24 (excluding VAT) for a single sponge. The company estimates that complete treatment with Endo-SPONGE will need on average 7 to 8 sponges. The Redyrob transplus bottle is bought separately, costing £20.87 per bottle (excluding VAT). Any glycerol-based hydrogel can be used, this costs between £1 and £1.50 per tube. These costs do not include the cost of the procedure, however treatment with Endo-SPONGE is a minimally invasive, transanal, endoscopic procedure and is therefore expected to have lower resource impact than surgical reintervention.

Costs of standard care

A complex large intestine procedure costs between £6,248 and £12,534 from the national tariff 2019 to 2020. However, this does not include the cost of an anastomotic leak complication.

Resource consequences

The company states that the device is being used in over 40 NHS centres in the UK.

The resource consequences of the technology are expected to be less than standard of care because of a reduced need for reoperations, permanent stomas and avoidance of sepsis.

Staff will need training to use the technology. The sponge needs to be changed every 48 to 72 hours, this will need to be done in an endoscopic room or operating theatre.