The application of TachoSil® for sealing colorectal anastomosis: a feasibility study.
OBJECTIVE
Anastomotic leakage is a frequent postoperative complication of colorectal resection. This nonrandomized study assessed the feasibility and safety of applying a haemostatic tissue sealant (TachoSil®) to colorectal anastomoses following resection.


METHODS
TachoSil was applied as reinforcement of the anastomotic line after laparoscopic or open colorectal resection. The primary endpoint was the proportion of patients for whom TachoSil application was considered feasible by both the investigator and an independent external assessor. Application was considered feasible if TachoSil fully adhered, covered ≥1cm beyond the margin of the anastomotic line and patches overlapped by ≥1cm. Individual investigator assessment of feasibility and adverse events 30 days after surgery were also recorded.


RESULTS
Twenty-five patients underwent anterior resection (seven open lower, nine open middle-upper, four laparoscopic lower and five laparoscopic middle-upper). In six cases a video-recording was not available because of technical problems. The primary endpoint was met in 12 of the remaining 19 patients (63%; 95% CI 38-84%), while in the other seven the application was recorded as not feasible because the assessor was unable to see the entire anastomosis. No application was assessed as unfeasible on the basis of visual evidence. When assessed by the investigator alone, TachoSil was considered feasible in all but one instance (96%; 95% CI 80-100%). There were 45 adverse events, of which 10 were serious. None was considered related to TachoSil. No deaths were reported.


CONCLUSIONS
Application of TachoSil to reinforce the anastomotic line in colorectal resections appears to be feasible and well tolerated.
Fawkham Manor Hospital, Fawkham, Kent, UK. mike.c.parker@btconnect.com
M C
MC
Parker
U
U
Pohlen
I H M
IH
Borel Rinkes
T
T
Delvin
D000368:Aged; D000714:Anastomosis, Surgical / Q000009:adverse effects / Q000379:methods*; D057868:Anastomotic Leak / Q000517:prevention & control*; D003107:Colorectal Surgery / Q000009:adverse effects / Q000379:methods*; D004338:Drug Combinations; D005240:Feasibility Studies; D005260:Female; D005340:Fibrinogen / Q000627:therapeutic use*; D006801:Humans; D010535:Laparoscopy; D008297:Male; D008875:Middle Aged; D013917:Thrombin / Q000627:therapeutic use*; D016896:Treatment Outcome
D004338:Drug Combinations; C518955:TachoSil; D005340:Fibrinogen; D013917:Thrombin