Vacuum-assisted early transanal closure of leaking low colorectal anastomoses: the CLEAN study

Abstract

Introduction: Non-healing of anastomotic leakage can be observed in up to 50% after total mesorectal excision for rectal cancer. This study investigates the efficacy of early transanal closure of anastomotic leakage after pre-treatment with the Endosponge^® therapy.

Methods: In this prospective, multicentre, feasibility study, transanal suturing of the anastomotic defect was performed after vacuum-assisted cleaning of the presacral cavity. Primary outcome was the proportion of patients with a healed anastomosis at 6 months after transanal closure. Secondary, healing at last follow-up, continuity, direct medical costs, functionality and quality of life were analysed.

Results: Between July 2013 and July 2015, 30 rectal cancer patients with a leaking low colorectal anastomosis were included, of whom 22 underwent neoadjuvant radiotherapy. Median follow-up was 14 (7-29) months. At 6 months, the anastomosis had healed in 16 (53%) patients. At last follow-up, anastomotic integrity was found in 21 (70%) and continuity was restored in 20 (67%) patients. Non-healing at 12 months was observed in 10/29 (34%) patients overall, and in 3/14 (21%) when therapy started within three weeks following the index operation. Major LARS was reported in 12/15 (80%) patients. The direct medical costs were €8933 (95% CI 7268-10,707) per patient.

Conclusion: Vacuum-assisted early transanal closure of a leaking anastomosis after total mesorectal excision with 73% preoperative radiotherapy showed that acceptable anastomotic healing rates and stoma reversal rates can be achieved. Early diagnosis and start of treatment seems crucial.

Keywords: Anastomotic leakage; Rectal cancer; Transanal closure; Vacuum therapy.

Fig. 1

Treatment flow chart of patients with anastomotic leakage after low anterior resection that underwent a vacuum-assisted early closure strategy

Fig. 2

Study flow chart

Fig. 3

Treatment strategies for patient with a non-healed anastomosis at routine sigmoidoscopy two weeks after transanal closure of the anastomotic defect

Fig. 4

Patient with a large dehiscence of the anastomosis that underwent successful treatment. A First sigmoidoscopy showing a 270 degrees dehiscence of the anastomosis with a transanal drain that was placed in the referring hospital. B Sigmoidoscopy image after two Endosponge^® procedures, showing granulation tissue with pus on the right side of the descending colon. C Image after the fifth Endosponge^® procedure showing a clean cavity with granulation tissue. D Two weeks follow-up sigmoidoscopy after transanal closure showing a reduced dehiscence, but with a residual defect. E Small residual sinus after a total of 8 Endosponge^® exchanges for a residual defect after transanal closure. F Sigmoidoscopy two week after the last Endosponge^® procedure, showing a healed anastomosis