Endo-SPONGE for treating low rectal anastomotic leak

1.1 Endo-SPONGE shows promise for treating low rectal anastomotic leaks. However, there is not enough good-quality evidence to support the case for routine adoption in the NHS.

1.2 Further evidence in the form of real-world data collection is recommended to address uncertainties about selection criteria, patient-reported outcome measures, stoma reversal and bowel function recovery compared with other treatments. Find out more in the section on further research in this guidance.

Why the committee made these recommendations

Anastomotic leak is a serious complication after colorectal surgery. Endo‑SPONGE is designed to treat leaks after a low rectal anastomosis.

There's not enough evidence assessing the clinical effectiveness of Endo‑SPONGE compared with other non-surgical or surgical treatments in the NHS. Observational studies suggest that Endo‑SPONGE may stop anastomotic leakage and reduce the chance of a permanent stoma, but this evidence is weak.

There are also uncertainties about the cost impact of using Endo-SPONGE in the NHS because of the weak clinical evidence.