Table 3.
Healing rates
| CLEAN study patients (n = 30) | Start Endosponge® therapy | ||
|---|---|---|---|
| <3 weeks (N = 15) | >3 weeks (N = 15) | ||
| Healed anastomosis 6 months following transanal closure | 16 (53%) | 10 (67%) | 6 (40%) |
| Healed anastomosis at end of follow-up | 21 (70%) | 11 (73%) | 10 (67%) |
| Successfully restored continuity at 6 months | 11/30 (37%) | 7 (47%) | 4 (27%) |
| Successfully restored continuity end of follow-up (%, n) | 20/30 (67%) | 11 (73%) | 9 (60%) |
| Median time from transanal closure to healed anastomosis (days) | 127 (14–722) | 92 (19–509) | 220 (14–722) |
| Median time to successful stoma closure from primary surgery (days) | 204 (92–624) | 193 (92–581) | 262 (121–624) |
| Median time to successful stoma closure from transanal closure (days) | 175 (72–556) | 175 (72–556) | 165 (78–541) |
| No. of patients with chronic sinus | 10/29 (35%)a | 3/14 (21%) | 7/15 (47%)a |
| Number of patients requiring resection of dysfunctional anastomosis (either redo or end colostomies)b | 6/30 (20%)b | 2 (13%) | 4 (27%) |
| No. of patients readmissioned for presacral abscess | 10/30 (33%) | 4 (27%) | 6 (40%) |
| Total hospital days for readmittance in post EVAC + transanal closure course (median, range)1 | 6 (0–47) | 6 (0–15) | 8 (0–47) |
aOne patient was lost to FU 7 months following the transanal closure and therefore it was unknown whether a chronic sinus had developed
bIn 3 patients with a chronic sinus, the stoma could be reversed successfully and in 2 patients with a chronic sinus further surgery was declined due to morbidity of the patient in one and widespread metastatic disease in the other, so therefore 5 patients with a chronic sinus were treated conservatively. On the other hand in one patient the anastomosis was resected two weeks after the transanal closure, as the two week sigmoidoscopy showed a complete dehiscence and this was considered to be the best treatment option (however, this patient did not develop a chronic sinus), so therefore the total number is 6. 1 = Includes all readmissions until end of follow-up, thereby including stoma reversals and redo procedures and resection of anastomosis