Circular anastomotic experimental fibrin sealant protection in deep colorectal anastomosis in pigs in a randomized 9-day survival study.

PURPOSE: The reported rate of clinically apparent anastomotic leakage (AL) in a low anterior resection of the rectum (LAR) (≤7 cm from the anal verge) using a circular double-stapled anastomosis (CDSA) without defunctioning stoma is up to 37.5 %. Since AL may result in life-threatening peritonitis, sepsis, and multiple organ failure, LAR and CDSA are regularly combined with defunctioning stoma. Accordingly, we now evaluated whether LAR and CDSA without defunctioning stoma but with extraluminal anastomotic application of an experimental fibrin sealant reduce the AL rate. This might prevent humans from defunctioning stoma increasing quality of life and decreasing surgical costs. METHODS: Forty 8-week-old pigs underwent LAR and CDSA in an end-to-end technique (descendo-rectostomy). Animals were randomized into a therapy and control group (gr.). The therapy gr. (n = 20) received an additional extraluminal circular application of an experimental fibrin sealant to the anastomosis. The objective was to assess the incidence of clinically apparent and non-clinically apparent leakage through the ninth postoperative day. Double-contrast barium CT radiographs of the colorectal region were performed on the ninth postoperative day or earlier, in case there were clinical signs of AL. All remaining animals were sacrificed on the ninth postoperative day and the anastomotic region was histopathologically analyzed. In case of earlier diagnosed AL, animals were sacrificed immediately. Blood samples were taken for complete blood count, chemistry, and coagulation profile prior to surgery and on the first, third, fifth, seventh, and ninth postoperative day. RESULTS: A circular extraluminal anastomotic application of an experimental fibrin protection decreased the rate of clinically and non-clinically apparent AL from 20 % (n = 4) in the control group to 5 % (n = 1) in the treatment group. Ulcerations were also observed in both gr. (control gr.-5 animals, therapy gr. -3 animals). All animals with AL showed necrosis surrounding the hole at the anastomoses. Three additional animals had a full wall defect at the anastomotic region that was blocked by the experimental fibrin sealant. The fibrin sealant was present at necropsy in all treated animals. CONCLUSION: Circular anastomotic protection with the experimental fibrin sealant blocked anastomotic full wall defects, preventing peritonitis and significantly reducing the AL rate from 25 to 5 %.

A new anastomotic leakage model in circular double stapled colorectal anastomosis after low anterior rectum resection in pigs.

BACKGROUND: A high incidence of anastomotic leakage (37.5%) is reported after low anterior rectal resection (LAR) and circular double-stapled anastomosis without protective ileostoma. Since the pathomechanism of anastomosis leakage is still unclear, a suitable animal model would be most desirable. METHODS: The objective was to assess the incidence of clinically apparent and inapparent leakage after LAR in pigs (n = 20). Endpoints were radiological, clinical, macroscopic, and histologic proof of anastomotic leakage on the 9th postoperative day. Integrity of anastomosis was assessed by double-contrast barium examination on 9th postoperative day. Animals were sacrificed and anastomoses were resected for histopathological investigation. In case of earlier clinical apparent anastomotic leakage, radiologic double-contrast barium was performed immediately. RESULTS: LAR with a circular double-stapled anastomosis without protective ileostoma was performed in 20 pigs (m:f = 8:12). Length of resection was 10-20 cm, anastomosis was performed 7 cm ab ano. Five animals (25%) developed clinical apparent anastomotic leakage (no appetite, fever, inactivity, tachypnea, discomfort, pain) between the 6th (n = 1) and 9th (n = 4) postoperative day, proven by double-contrast barium radiographs. Additionally in 1 animal clinical inapparent anastomotic insufficiency was observed radiologically. Total rate of leakage was 30% (n = 6). These results were confirmed by leucocytosis, low potassium levels, in two cases high ALT and AST and local peritonitis in all cases. CONCLUSION: Including one additional case of clinical inapparent leakage, total rate of anastomotic leakage was 30% (6/20). Thus we managed to establish a new experimental model of anastomotic leakage after low rectal resection comparable to the human situation.

[Additional personal contributions for minimally invasive surgery : How high is patient acceptance?]. / Zuzahlungspauschale bei minimal-invasiven Operationen : Wie hoch ist die Patientenakzeptanz?

OBJECTIVE: Increasing costs of the healthcare system might decrease the spectrum of insurance financed medical treatment in the future. Therefore we evaluated whether patients are prepared to pay partial costs of their own, especially for minimally invasive surgery. METHODICS: Between 1st July 2007 and 1st July 2008 patients were asked in a prospective trial preoperatively and postoperatively whether they would be prepared to pay an additional invoice of 200 EUR for a minimally invasive operation. Payment was reasoned by the hypothesis that insurance companies will reduce the DRG payment while costs are rising. RESULTS: A total of 750 patients, men:women=279 (37.2%):471 (62.8%) undergoing elective minimally invasive operations were included in the trial. For the majority of patients (m=266:13; w=448:23) it was very important to be operated on in a center for minimally invasive surgery. Preoperatively and postoperatively the majority of patients voted for individual payment of 200 EUR to make minimally invasive surgery possible (84.4 versus 84.1%, respectively, p=0.79). Although 80.4% (411/511) of patients with national health insurance voted for payment, voting of patients with private insurance was significantly increased to 92.9% (222/239) (p<0.001). Voting for individual payment increased with a rising level of education (p=0.017), job position and income (p<0.001). Furthermore, it was significantly increased in married compared to single patients (86.5% versus 78.4%, respectively, p=0.038). CONCLUSION: Before the operations 84.4% of patients voted for additional individual payment for minimally invasive operations but this was dependent on the socio-economic status.