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    Endo-SPONGE for treating low rectal anastomotic leakage

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    3 Evidence

    Clinical evidence

    Relevant evidence comes from 20 observational studies, including 2 comparative studies

    3.1 There were 20 studies relevant to the decision problem in the scope:

    • 2 comparative studies (Schiffmann et al. 2019, Wasmann et al. 2019)

    • 4 prospective studies (Jiménez Rodríguez et al. 2018, Milito et al. 2017, Rottoli et al. 2018, Strangio et al. 2015)

    • 14 retrospective studies (Arezzo et al. 2015, Boschetti et al. 2018, Huisman et al. 2019, Katz et al. 2018, Keskin et al. 2015, Kuehn et al. 2016, Manta et al. 2016, Mussetto et al. 2017, Nerup et al. 2013, Riss et al. 2010, Riss et al. 2009, Srinivasamurthy et al. 2013, van Koperen et al. 2009, Weidenhagen et al. 2008).

    There were also 3 abstracts of non-comparative studies included (DiMitri et al. 2010, Martel et al. 2013, and McAuley et al. 2013). There were 3 studies done in the UK.

    The evidence is limited because of a heterogenous population and inconsistent reported outcomes

    3.2 The external assessment centre (EAC) considered the quality of the evidence for Endo-SPONGE very low. It found a high risk of bias because of the retrospective study design and small sample sizes (ranging from 3 to 34). It noted the clinical heterogeneity related to population characteristics and the definition of surgical site infections and success. It also found inconsistencies for how long Endo‑SPONGE was in place and how many times it was changed, the length and frequency of follow up and concurrent or additional treatments. This might reflect the clinical uncertainty and variation in practice when treating people with anastomotic leakage. The clinical experts suggested that there is no clearly defined care pathway, and treatment is based on a number of factors. These include the patient's overall condition, the anastomotic defect size and location, the indication for primary resection and the presence of a proximal stoma.

    The limited evidence suggests that Endo-SPONGE could be an option to treat anastomotic leakage

    3.3 The limited evidence suggests that Endo‑SPONGE could be considered as a treatment option for anastomotic leakage. The success rate of cavity closure for Endo‑SPONGE was about 85% and ranged from 40% to 100%, but the definition of success varied across studies. The stoma reversal rate after successful Endo-SPONGE treatment was about 77%, ranging from 38.5% to 92.3%. One study reported that 6 out of 8 patients would be willing to have Endo‑SPONGE treatment again if needed.

    Cost evidence

    The company estimates that using Endo-SPONGE saves £2,419.50 per person in the first year

    3.4 The company presented a de novo cost analysis with an Endo‑SPONGE decision tree and a comparator decision tree. Each decision tree had 4 branches for different grades of anastomotic leak that may result in non-surgical or surgical treatment. The results from the company model estimated that Endo-SPONGE was cost saving by £2,419.50 per person in the first year.

    There are 3 possible scenarios proposed by the EAC to reflect clinical practice in the NHS

    3.5 The EAC noted that there was no standard treatment pathway for anastomotic leakage management. The procedure cost varied by care setting (inpatient or outpatient), types of sedation (general or local anaesthetic) and whether or not it was combined with other interventions. The EAC proposed 3 scenarios based on available evidence and expert advice to explore the cost impact in clinical practice.

    The EAC has revised key clinical parameters based on published data but also uses clinical parameters from the company submission

    3.6 The EAC considered the company model structure, a 1‑year cycle and a 10‑year time horizon to be appropriate. It changed the clinical and cost parameters based on published studies and expert advice. However, there was uncertainty about the most appropriate inputs to the model because there was no clearly defined care pathway. The EAC applied the clinical parameters submitted by the company with its revised parameters to the cost model.

    The cost impact of Endo-SPONGE varies depending on the scenarios and clinical parameters considered

    3.7 The EAC noted that the cost impact of Endo‑SPONGE compared with percutaneous drainage varied depending on the scenarios and clinical parameters considered. One scenario expected Endo-SPONGE insertion to be done in theatre under general anaesthesia with subsequent sponge changes in an outpatient setting such as an endoscopy suite. Using the company's clinical parameters in the model, this scenario estimated that Endo‑SPONGE would save £726 per person compared with percutaneous drainage in the first year. Using the EAC alternative clinical inputs in the model, Endo‑SPONGE was estimated to have an additional cost of £1,141 per person compared with percutaneous drainage. If both the insertion and replacement procedures were done in an operating theatre under general anaesthesia, then Endo‑SPONGE was cost incurring in the first year. If a percutaneous drain was used as well as Endo‑SPONGE, then the modelling estimated that the treatment was cost incurring in the first year.

    Endo-SPONGE may be cost saving in the long term (10 years after the insertion procedure)

    3.8 The EAC model estimated that Endo-SPONGE was cost saving over a 10‑year time horizon. This was when the insertion procedure was done in an operating theatre and sponge changes were done in an endoscopy suite or day-case theatre under light sedation. Using the company's or EAC's clinical parameters, this would result in cost savings of £2,829.30 and £68.20 per person at 10 years, respectively, compared with percutaneous drainage.