[Observations on the use of TachoSil® in cholecystectomy - a multicentre, prospective, single-arm cohort study]. / Anwendungsbeobachtung zu TachoSil® bei der Cholezystektomie - Eine multizentrische prospektive einarmige Kohortenstudie.

ABSTRACT

An observational study on TachoSil® as used in the gall bladder surgery and an analysis of the experience obtained by employing a haemostatic agent in one of the most common procedures in general and visceral surgery have been carried out. The aim of the study was to answer the following questions. When is TachoSil® in routine use? Does TachoSil® have a positive effect on the perioperative course? Is TachoSil® suitable for the routine application in difficult cholecystectomy? In the present single-arm prospective cohort study only departments with specialisation in general and visceral surgery of 40 clinics in Germany participated. Although 500 planned interventions were to be documented in 2007, only 169 operations were actually reported. The numerical results were statistically analysed and summarised. Before the operation was carried out a classification according to the bleeding history was performed. The surgery was performed in the open, laparoscopic or converted modes. During the intervention the surgeon decided about the application of TachoSil® on the basis of a risk index. According to the collected data, it was significant that TachoSil® was used more frequently when either a cholecystectomy was performed in the open mode or on conversion from laparoscopic to the open mode. Also it was significant that TachoSil® was chosen when a patient had a defect in blood coagulation or when the cholecystectomy was part of a multivisceral resection. 59.7% of the patients where TachoSil® was used had a known risk of haemorrage. 12.4 % of the patients where TachoSil was used underwent at least one intervention to compensate intraoperative blood loss before (10.1 % blood transfusion, 4.7 % blood substitutes). In 97 % TachoSil® was used as a haemostatic agent, in 30.2 % it was chosen to prevent a biliary leak and in 11.24 % to augment vulnerable tissue (multiple answers possible). Concerning laparoscopic cholecystectomy, it was significant that the surgeons decided to take middle-sized patches (4.8 × 4.8 cm) more frequently. Only in 6 cases were the small-sized patches (3 × 2.5 cm) chosen. 90.5 % of the patches were placed in the liver bed. In 5.3 % of the cases the position was not documented. In 4.1 % the patch was placed upon the hepatoduodenal ligament or a suture of the bile duct. To conclude, in difficult cholecystectomies and cholecystectomies as part of multivisceral resection, the use of TachoSil® is an option for experts to secure the seam, to prevent a bile leakage and to control bleeding in the surgical areas.