1 Recommendations

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

1.2 Research is recommended to address uncertainties about the benefits of Endo-SPONGE. This research should:

  • identify the selection criteria for people who could have Endo-SPONGE

  • assess the comparative rate of stoma reversal and bowel function recovery using Endo‑SPONGE compared with other treatments

  • include patient-reported outcome measures such as health-related quality of life

  • determine the relative cost of Endo-SPONGE compared with other treatments for anastomotic leakage.

Why the committee made these recommendations

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

There is no good-quality evidence assessing the clinical effectiveness of Endo‑SPONGE compared with other non-surgical or surgical treatments in the NHS. Evidence from observational studies suggests that Endo‑SPONGE may reduce anastomotic leakage and the chance of a permanent stoma, but this evidence is limited. Based on the published evidence and expert advice, it is uncertain how patients would be selected for Endo‑SPONGE treatment.

There are uncertainties about the cost modelling because of the weak clinical evidence. Endo-SPONGE may be cost saving in the long term (over 10 years) compared with a percutaneous drain. But, this is not certain because there is no clinical consensus about the care pathway for people who have leakage after a low rectal anastomosis.

Further research on Endo‑SPONGE is recommended to resolve the clinical and cost uncertainties.