THE BURDEN ASSOCIATED WITH INTRA-OPERATIVE ANASTOMOTIC LEAKS IN COLORECTAL SURGERY

Author(s)

Schiff A1, Roy S2, Pignot M3, Laschke K3, Stadler J3, Ghosh SK4, Yin C5, Fegelman E1
1Johnson & Johnson (Ethicon), Cincinnati, OH, USA, 2Johnson and Johnson Global Surgery, Somerville, NJ, USA, 3Kantar Health, Munich, Germany, 4Global Health Economics and Market Access, Ethicon, Inc., Cincinnati, OH, USA, 5JnJ Medical AP, Singapore, Singapore

OBJECTIVES: Anastomotic leaks following colorectal resections result in a significant clinical and economic burden. To complement published data on post-operative leaks, this study aimed to understand intra-operative approaches to managing positive anastomotic leak tests.  METHODS: Electronic medical records of patients in China, Japan, and Korea with a positive leak test during colon resection were reviewed as part of a global retrospective, cross-sectional study. Surgeon information, patient demographics, comorbidities, surgical techniques, intraoperative interventions and post-operative outcomes were extracted. Statistics are reported as percentages and mean ± standard deviation.

RESULTS: Data were reviewed for 165 patients with primary or metastatic colorectal cancer who  presented a positive intra-operative leak test following resection procedure (36% anterior rectal resection, 26% laparoscopic sigmoidectomy, 14% laparoscopic left hemicolectomy, 14% open sigmoidectomy, and 10% open left hemicolectomy). Intraoperative anastomotic leak rates were estimated by participating surgeons to be at an average of 5%. Prior to leak testing, 42% patients’ anastomoses were over sewn, and over 2% were reinforced with a sealant. Following a positive test, about 90% of patients underwent over sewing of the staple line (median 4 suture strands used), sealant was applied in about 12% patients (median 2 sealant tubes used), a new anastomosis was created in about 6% patients (all with circular stapler), and about 7% had a colostomy. The average time required for these interventions was 19.4 ± 13.6 minutes. Despite addressing the intra-operative leak, a post-operative leak occurred in about 15% of patients. CONCLUSIONS: Intraoperative anastomotic leaks are mostly managed by over sewing the staple line or by applying a surgical sealant, which can be time-, labor- and cost-intensive. Significant rates of post-operative leaks were observed despite addressing intra-operative leaks. Approaches towards standardizing anastomosis creation may help reduce the incidence of intraoperative leaks, the variability in management strategies, and the subsequent outcomes.

Conference/Value in Health Info

2016-09, ISPOR Asia Pacific 2016, Singapore

Value in Health, Vol. 19, No. 7 (November 2016)

Code

PRM7

Topic

Clinical Outcomes, Methodological & Statistical Research, Real World Data & Information Systems, Study Approaches

Topic Subcategory

Clinical Outcomes Assessment, Confounding, Selection Bias Correction, Causal Inference, Reproducibility & Replicability

Disease

Gastrointestinal Disorders, Oncology

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