Specialist commentator comments
Comments on this technology were invited from clinical specialists working in the field and relevant patient organisations. The comments received are individual opinions and do not represent NICE's view.
All 3 specialists were familiar with his technology, 2 have used the device and the third specialist would like to use the technology.
All specialists agreed that the technology was innovative and that it had not been superseded or replaced by another treatment.
All specialists stated the technology can be helpful in managing extra peritoneal rectal anastomotic leakage when it can be accessed by the transanal route in patients with no sepsis or sepsis with contained leakage. One specialist noted that the technology may be particularly useful when the cavity is located in the posterior, low presacral area. Another expert noted that the technology may also be useful after gynaecological surgery.
One specialist noted that using Endo-SPONGE can reduce the need for immediate surgery at a time when the patient is most unwell, allowing time for nutrition and physical health to improve. Two specialists stated that further surgical procedures might be avoided altogether. One specialist noted that using Endo‑SPONGE could reduce the need for long-term and permanent stomas and stated that the technology was less invasive than other treatment options. One specialist stated that using the technology would lead to enhanced recovery rates and improved outcomes for patients.
Only 1 of the specialists had experience of a healed anastomosis after treatment with Endo-SPONGE, in 1 out of a total of 3 patients treated.
All specialists agreed that using Endo-SPONGE could lead to substantial cost savings for the NHS compared with standard care. One specialist noted that using Endo-SPONGE could reduce the need for high-risk surgery and associated costs. One specialist stated that the technology can be used in an inpatient or an outpatient setting, noting that the sponge would need changing every 2 to 3 days. All specialists agreed that using Endo-SPONGE could lead to quicker healing of anastomosis and quicker discharge from hospital. One specialist noted that in their experience the technology had helped in the control of sepsis.
All specialists stated that knowledge of the technology is not widespread in the NHS and that it is only used in a few hospitals. Two specialists noted that adopting the technology will need availability of endoscopy services and equipment and training for endoscopists. One specialist noted that in their experience, adopting the technology had been a simple process and treatment could be administered by a nurse specialist. Another specialist noted the importance of assistance from a nurse specialist. One specialist advised that an approved certification system for competence in using Endo-SPONGE should be set up in the UK.
The specialists noted that extraperitoneal leakage of rectal anastomosis with contained sepsis amenable to Endo-SPONGE therapy is a rare complication, happening in 2 to 4 patients per hospital per year, in their experience. One specialist who has been using Endo-SPONGE for 5 years has used it in 3 patients out of a total of 40 to 50 rectal resections per year.
Two specialists noted some practical problems with using the technology and warned that it can cause damage to the healthy adjacent bowel if not used carefully. One specialist also stated that the technology may not be suitable for people taking anticoagulants because of the risk of excess bleeding from the negative suction effect. One specialist noted that some patients may not tolerate treatment with the technology because of its transanal administration.
One specialist advised that use of Endo-SPONGE would be classified as a source control for grade 1 anastomotic leakage (no sepsis) and in grade 2 anastomotic leakage (sepsis with contained leak/abscess). Two specialists advised that audit data should be collected on using Endo-SPONGE. One specialist noted that it would not be possible to do randomised studies in this population but that case series studies would provide further evidence.