Clinical and technical evidence

A literature search was carried out for this briefing in accordance with the interim process and methods statement. This briefing includes the most relevant or best available published evidence relating to the clinical effectiveness of the technology. Further information about how the evidence for this briefing was selected is available on request by contacting mibs@nice.org.uk.

Published evidence

This briefing summarises 7 studies, including a total of 277 adult patients with anastomotic leakage. These studies have been selected from a wider evidence base as the most relevant and informative. The studies are non-comparative case series and most have included low patient numbers; the longest follow up was 29 months.

Table 1 summarises the clinical evidence as well as its strengths and limitations.

Overall assessment of the evidence

The studies for Endo-SPONGE have low patient numbers and are non-comparative. This is likely to be because of the low incidence and severity of this complication. Comparative trial design is also challenging because it raises ethical issues around randomising patients at risk of infection and sepsis.

The studies suggest that Endo-SPONGE is a safe treatment for low rectal anastomotic leak and that it can lead to healing without the need for surgery. Several studies indicate that Endo-SPONGE is most effective when used soon after the anastomosis forms rather than in anastomotic leaks with delayed diagnosis. The studies have good length of follow up and indicate that the treatment effect is long lasting but that patients should be carefully monitored after healing because some studies reported abscess and sinus formation.

The studies include a range of patients and anastomotic leaks, however, further evidence on which patient groups would most benefit from Endo-SPONGE is desirable.

Table 1 Summary of selected studies

Boschetti et al. (2018)

Study size, design and location

29 people with abscesses or fistulas from anastomotic leakage after rectal resection or colectomy in a retrospective case series.

Location: France.

Intervention and comparator(s)

Endo-SPONGE.

No comparator.

Key outcomes

Closure of the cavity happened in 27/29 patients (93%), which was sustained in 24/27 patients (89%) at 6 months. The treatment was well tolerated and done on an outpatient basis without sedation. In this study, anastomotic leakage was treated efficiently with Endo-SPONGE without sedation or stoma in 31% of cases.

Strengths and limitations

According to the authors, it is the first case series in which half of the patients did not have a diverting stoma. The authors note that patients without a diverting stoma tended to need a shorter duration of treatment with Endo-SPONGE. Around half of the people included in the study had been referred to the study after late failure of standard treatment for anastomotic leakage.

Bortslap et al. (2018)

Study size, design and location

30 people with rectal cancer and leaking low colorectal anastomosis included in a prospective, multicentre, feasibility study.

Location: Netherlands.

Intervention and comparator(s)

Endo-SPONGE.

No comparator.

Key outcomes

22/30 patients had neoadjuvant radiotherapy during follow up (median 14 months, range 7 to 29 months). At 6 months, anastomosis was healed in 16 (53%) patients, 10/16 started treatment with Endo-SPONGE early (within 3 weeks of surgery), whereas the other 6 started treatment later. 7/8 patients who did not have neoadjuvant radiotherapy had healed at 6 months. At the end of follow up anastomosis had healed in 21/30 patients (11 had early treatment and 10 had later treatment), median time for the anastomosis to heal was 127 days (range 14 to 722). In 10 patients the anastomotic leak developed into a chronic sinus. 6 patients whose anastomotic leak did not heal needed further surgery.

Strengths and limitations

The authors noted that chronic sinus was more common in people who had started treatment late (21% early treatment versus 47% later treatment) and suggest that Endo-SPONGE is less effective when the anastomosis is diagnosis is delayed. The authors note that compared with previous studies reporting results for 'wait-and-see' cohorts time to healing and percentage of patients healed was improved using Endo-SPONGE.

Jiménez Rodríguez et al. (2018)

Study size, design and location

22 people with low colorectal anastomosis leakage or opening of the rectal stump after anterior resection for rectal cancer in a case series.

Location: Spain.

Intervention and comparator(s)

Endo-SPONGE.

No comparator.

Key outcomes

Mean time to healing was 22.3±14.7 days. Full resolution was achieved in 19 patients (followed up to 1 year). Ileostomy closure was done in 5 patients (38.46%) during follow up. None of these patients showed leakage signs. Statistically significant differences were obtained depending on the onset of therapy, with better results in patients who had earlier vacuum-assisted therapy (before the sixth week after initial surgery), p=0.041.

Strengths and limitations

The authors noted that Endo-SPONGE is an alternative to surgery that can be safely administered in an ambulatory setting. The authors also note that colonic transit was only recovered in a few patients.

Mussetto et al. (2017)

Study size, design and location

11 people recovering from anterior resection of the rectum for rectal cancer with colorectal anastomosis, included in a retrospective case series.

Location: Italy.

Intervention and comparator(s)

Endo-SPONGE.

No comparator.

Key outcomes

10/11 patients had closure of the anastomotic leakage after a mean of 16 sponge changes. Anastomotic stricture happened in 2 patients, 1 was treated with endoscopic dilation and the other with a 5-week stent placement. Treatment failure happened for 1 patient whose wound reopened after 23 Endo-SPONGE treatments despite having initially responded well.

Strengths and limitations

The follow up of this study was longer; mean 29 months, range 6 to 64 months. The authors noted that the size of anastomotic leakages included in this study were larger than those in other studies evaluating Endo-SPONGE (median 7.5 cm).

Strangio et al. (2015)

Study size, design and location

149 people included in a case series and literature review.

Location: Italy.

Intervention and comparator(s)

Endo-SPONGE.

No comparator.

Key outcomes

131/149 patients had complete healing of presacral cavity.

No studies reported any mortality relating to the procedure.

Strengths and limitations

This study combined data from a case series of 25 people with data from the studies identified in the literature review. These data were pooled together and analysed. It is not clear if the patient populations included in the literature review studies were comparable or not.

Riss et al. (2010)

Study size, design and location

20 people who had had successful treatment with Endo-SPONGE (after rectal cancer surgery, 17 with anastomotic leakage and 3 with insufficiency of rectal stump) included in a multicentre consecutive case series.

Location: Austria.

Intervention and comparator(s)

Endo-SPONGE.

No comparator.

Key outcomes

Patients were followed up for a median of 17.1 months (range 1.5 to 29.8 months) after successful treatment with Endo-SPONGE. 5 patients died during follow up, 4 because of tumour progression and 1 because of liver cirrhosis. 1 patient developed anal stenosis which was improved with anal dilation. 5 patients (25%) developed recurrent symptomatic abscesses; 3 patients had abscesses needing surgical intervention (Hartmann's procedure), 1 needed CT‑guided drainage and 1 had only minimal clinical signs that did not need treatment during the follow-up period. The authors noted that they were unable to identify any predictive factors for recurrent abscess formation because of the low patient numbers.

Strengths and limitations

The authors were unable to identify the cause of recurrent abscesses in 25% of patients because of the low patient enrolment and non-comparative design of the study. They suggest that this should be further investigated in a randomised trial with 2‑year follow up.

Koperen et al. (2009)

Study size, design and location

16 people (13 had had surgery for rectal cancer and 3 for ulcerative colitis) included in a multicentre case series.

Location: Netherlands.

Intervention and comparator(s)

Endo-SPONGE.

No comparator.

Key outcomes

8 patients had Endo-SPONGE treatment within 6 weeks of surgery, the remaining 8 had Endo-SPONGE more than 6 weeks after surgery. In the earlier treatment group Endo-SPONGE was in place for a median of 24 days and closure of the wound happened in 6 patients (75%). In the later treatment group, wound closure happened in 3 patients (38%). Median time to closure was 40 days with a median of 13 sponge replacements.

Strengths and limitations

The authors describe some differences between centres of how Endo-SPONGE was administered, for example with anaesthesia, sedation or without. The authors state that the follow-up (median 4 months) was not enough to evaluate the long-term effectiveness of Endo-SPONGE.

Recent and ongoing studies