Elias Sdralis1, Anna Tzaferai1, Spyridon Davakis2, Athanasios Syllaios3, Ali Kordzadeh1, Bruno Lorenzi1, Alexandros Charalabopoulos3. 1. Regional Oesophago-Gastric Cancer Centre, Department of Upper Gastrointestinal Surgery, Broomfield Hospital, Mid Essex Hospital Services NHS Trust, Chelmsford, Essex, UK. 2. Regional Oesophago-Gastric Cancer Centre, Department of Upper Gastrointestinal Surgery, Broomfield Hospital, Mid Essex Hospital Services NHS Trust, Chelmsford, Essex, UK; First Department of Surgery, Laiko General Hospital, National and Kapodistrian University of Athens, Athens, Greece. Electronic address: spdavakis@gmail.com. 3. Regional Oesophago-Gastric Cancer Centre, Department of Upper Gastrointestinal Surgery, Broomfield Hospital, Mid Essex Hospital Services NHS Trust, Chelmsford, Essex, UK; First Department of Surgery, Laiko General Hospital, National and Kapodistrian University of Athens, Athens, Greece.
Abstract
PURPOSE:Fibrin sealant (Tisseel) is a human protein and thrombin soluble fibrinogen that has been indicated for reinforcement of gastro-intestinal anastomoses to prevent leakage. The objective of this study is to examine the impact of fibrin sealant regarding anastomotic leak, following Ivor-Lewis procedure. METHODS: This is a prospective comparative study on 2-stage oesophagectomy for cancer of the distal oesophagus or oesophagogastric junction. N = 57 individuals were randomly subjected; n = 22 patients toTisseel in combination to surgical anastomosis versus n = 35 patients to surgical anastomosis alone. The test of probability was assessed through Chi-Square, independent samples paired T-Test and Log-Rank analysis. RESULTS: Of the 57 cases included, 56 underwent hybrid and 1 open oesophagectomy. In the Tisseel group, n = 5(22.7%) developed anastomotic leak comparing to n = 3(8.6%) of the control group. No statistically significant difference in leak rate was shown between the two groups; the test of probability was rejected. CONCLUSIONS: Our results are not supportive of Tisseel tissue sealing property on the intrathoracic oesophago-gastric anastomosis and fibrin sealant's use cannot be justified.
RCT Entities:
PURPOSE: Fibrin sealant (Tisseel) is a human protein and thrombin soluble fibrinogen that has been indicated for reinforcement of gastro-intestinal anastomoses to prevent leakage. The objective of this study is to examine the impact of fibrin sealant regarding anastomotic leak, following Ivor-Lewis procedure. METHODS: This is a prospective comparative study on 2-stage oesophagectomy for cancer of the distal oesophagus or oesophagogastric junction. N = 57 individuals were randomly subjected; n = 22 patients to Tisseel in combination to surgical anastomosis versus n = 35 patients to surgical anastomosis alone. The test of probability was assessed through Chi-Square, independent samples paired T-Test and Log-Rank analysis. RESULTS: Of the 57 cases included, 56 underwent hybrid and 1 open oesophagectomy. In the Tisseel group, n = 5(22.7%) developed anastomotic leak comparing to n = 3(8.6%) of the control group. No statistically significant difference in leak rate was shown between the two groups; the test of probability was rejected. CONCLUSIONS: Our results are not supportive of Tisseel tissue sealing property on the intrathoracic oesophago-gastric anastomosis and fibrin sealant's use cannot be justified.
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