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Dacron vs. PTFE as bypass materials in peripheral vascular surgery - systematic review and meta-analysis
Stephanie Roll, Jacqueline Muller-Nordhorn, Thomas Keil, Hans Scholz, Daniela Eidt, Wolfgang Greiner and Stefan N Willich Fri, 19 Dec 2008 00:00:00 -0000
Background: In peripheral vascular bypass surgery different synthetic materials are available for bypass grafting. It is unclear which of the two commonly used materials, polytetrafluoroethylene (PTFE) or polyester (Dacron(R)) grafts, is to be preferred. Thus, the aim of this meta-analysis and systematic review was to compare the effectiveness of these two prosthetic bypass materials (Dacron(R) and PTFE). Methods: We performed a systematic literature search in MEDLINE, Cochrane-Library - CENTRAL, EMBASE and other databases for relevant publications in English and German published between 1999 and 2008. Only randomized controlled trials were considered for inclusion. We assessed the methodological quality by means of standardized checklists. Primary patency was used as the main endpoint. Random-effect meta-analysis as well as pooling data in life table format was performed to combine study results. Results: Nine randomized controlled trials (RCT) were included. Two trials showed statistically significant differences in primary patency, one favouring Dacron(R) and one favouring PTFE grafts, while 7 trials did not show statistically significant differences between the two materials. Meta-analysis on the comparison of PTFE vs. Dacron(R) grafts yielded no differences with regard to primary patency rates (hazard ratio 1.04 (95% confidence interval [0.85;1.28]), no significant heterogeneity (p=0.32, I2=14%)). Similarly, there were no significant differences with regard to secondary patency rates. Conclusions: Systematic evaluation and meta-analysis of randomized controlled trials comparing Dacron(R) and PTFE as bypass materials for peripheral vascular surgery showed no evidence of an advantage of one synthetic material over the other.
Neoadjuvant chemoradiation followed by surgery versus surgery alone for patients with adenocarcinoma or squamous cell carcinoma of the esophagus (CROSS)
M van Heijl, JJB van Lanschot, LB Koppert, MI van Berge Henegouwen, K Muller, EW Steyerberg, H van Dekken, BPL Wijnhoven, HW Tilanus, DJ Richel, ORC Busch, JF Bartelsman, CCE Koning, GJ Offerhaus and A van der Gaast Wed, 26 Nov 2008 00:00:00 -0000
Background: A surgical resection is currently the preferred treatment for esophageal cancer if the tumor is considered to be resectable without evidence of distant metastases (cT1-3 N0-1 M0). A high percentage of irradical resections is reported in studies using neoadjuvant chemotherapy followed by surgery versus surgery alone and in trials in which patients are treated with surgery alone. Improvement of locoregional control by using neoadjuvant chemoradiotherapy might therefore improve the prognosis in these patients. We previously reported that after neoadjuvant chemoradiotherapy with weekly administrations of Carboplatin and Paclitaxel combined with concurrent radiotherapy nearly always a complete R0-resection could be performed. The concept that this neoadjuvant chemoradiotherapy regimen improves overall survival has, however, to be proven in a randomized phase III trial.Methods/designThe CROSS trial is a multicenter, randomized phase III, clinical trial. The study compares neoadjuvant chemoradiotherapy followed by surgery with surgery alone in patients with potentially curable esophageal cancer, with inclusion of 175 patients per arm.The objectives of the CROSS trial are to compare median survival rates and quality of life (before, during and after treatment), pathological responses, progression free survival, the number of R0 resections, treatment toxicity and costs between patients treated with neoadjuvant chemoradiotherapy followed by surgery with surgery alone for surgically resectable esophageal adenocarcinoma or squamous cell carcinoma. Over a 5 week period concurrent chemoradiotherapy will be applied on an outpatient basis. Paclitaxel (50 mg/m2) and Carboplatin (Area-Under-Curve = 2) are administered by i.v. infusion on days 1, 8, 15, 22, and 29. External beam radiation with a total dose of 41.4 Gy is given in 23 fractions of 1.8 Gy, 5 fractions a week. After completion of the protocol, patients will be followed up every 3 months for the first year, every 6 months for the second year, and then at the end of each year until 5 years after treatment. Quality of life questionnaires will be filled out during the first year of follow-up.DiscussionThis study will contribute to the evidence on any benefits of neoadjuvant treatment in esophageal cancer patients using a promising chemoradiotherapy regimen.Trial registrationISRCTN80832026
What happens to the external carotid artery following carotid endarterectomy?
Saleh M Abbas, David Adams and Peter Vanniasingham Tue, 25 Nov 2008 00:00:00 -0000
AimsThe effect of carotid endarterectomy on the patency of the external carotid artery is unknown. We conducted a retrospective study to evaluate the long-term changes in the external carotid artery following carotid endarterectomy. Methods: Data was prospectively recorded for all patients who had carotid endarterectomy between 1997 and 2006 in our vascular surgical unit. These patients had follow-up with carotid duplex ultrasound to assess the patency of the internal and external carotid artery. The data were retrieved and evaluated for patency and flow characteristic in both arteries before and after surgery. Results: Carotid endarterectomy was performed on 255 occasions in 236 patients over the ten year study period. Immediate and long-term outcome of carotid endarterectomy is comparable to results at other major centers. Stenosis of the external carotid artery as detected by duplex scan occurred in 5.5% of patients and was totally asymptomatic. Conclusion: Our results of carotid endarterectomy are comparable to other centers. Long-term follow up of the external carotid artery with duplex scan showed asymptomatic stenosis in a small percentage of patients.
Aortic replacement in aorto-occlusive disease: an observational study
Gareth Morris-Stiff, Samuel Ogunbiyi, Richard K Winter, Russell Brown and Michael H Lewis Fri, 31 Oct 2008 00:00:00 -0000
Background: For many patients with aorto-occlusive disease, where stent deployment is not possible, surgery remains the only treatment option available. The aim of this study was to assess the results of aortic reconstruction surgery performed in patients with critical ischaemia. Methods: All patients with critical ischaemia undergoing surgery during 1991–2004 were identified from a prospectively maintained database. Mortality data was verified against death certificate data. Demographic and clinical data were obtained from the clinical notes and the radiology database. Disease was classified as: type I – limited to aorta and common iliac arteries; type II – external iliac disease and type III combined aortic, iliac and infra-inguinal disease. Results: 86 patients underwent aortic replacement surgery all of whom had critical ischaemia consisting of: type I (n = 16); type II (n = 37) and type III (n = 33). The 30-day mortality rate was 10.4%, the one-year patient survival was 80%, and the 1-year graft survival was 80%. At 2 years the actual patient survival was 73% and no additional graft losses were identified. All patients surviving 30 days reported excellent symptomatic relief. Early, complications occurred in 6 (7%) patients: thrombosis within diseased superficial femoral arteries (n = 4); haemorrhage and subsequent death (n = 2). Ten (14%) late complications (> 12 months) occurred in the 69 surviving patients and included: anastomotic stenosis (n = 3); graft thrombosis (n = 4), graft infection (n = 3). Four patients developed claudication as a result of more distal disease in the presence of a patent graft, and 1 patient who continued smoking required an amputation for progressive distal disease. Conclusion: Aortic reconstruction for patients with extensive aorto-occlussive disease provides long-standing symptomatic relief for the majority of patients. After the first year, there is continued patient attrition due to co-existent cardiovascular disease but no further graft losses.
Clinical evaluation of an air-capsule technique for the direct measurement of intra-abdominal pressure after elective abdominal surgery
Jens Otto, Daniel Kaemmer, Andreas Biermann, Marc Jansen, Rolf Dembinski, Volker Schumpelick and Alexander Schachtrupp Fri, 17 Oct 2008 00:00:00 -0000
Background: The gold standard for assessment of intraabdominal pressure (IAP) is via intravesicular pressure measurement (IVP). This accepted technique has some inherent problems, e.g. indirectness. Aim of this clinical study was to assess direct IAP measurement using an air-capsule method (ACM) regarding complications risks and agreement with IVP in patients undergoing abdominal surgery. Methods: A prospective cohort study was performed in 30 patients undergoing elective colonic, hepatic, pancreatic and esophageal resection. For ACM a Probe 3 (Spiegelberg®, Germany) was placed on the greater omentum. It was passed through the abdominal wall paralleling routine drainages. To compare ACM with IVP t-testing was performed and mean difference as well as limits of agreement were calculated. Results: ACM did not lead to complications particularly with regard to organ lesion or surgical site infection. Mean insertion time of ACM was 4.4 days (min-max: 1–5 days). 168 pairwise measurements were made. Mean ACM value was 7.9 ± 2.7 mmHg while mean IVP was 8.4 ± 3.0 mmHg (n.s). Mean difference was 0.4 mmHg ± 2.2 mmHg. Limits of agreement were -4.1 mmHg to 5.1 mmHg. Conclusion: Using ACM, direct IAP measurement is feasible and uncomplicated. Associated with relatively low pressure ranges (<17 mmHg), results are comparable to bladder pressure measurement.
Could lymphatic mapping and sentinel node biopsy provide oncological providence for local resectional techniques for colon cancer? A review of the literature
Ronan A Cahill, Joel Leroy and Jacques Marescaux Wed, 24 Sep 2008 00:00:00 -0000
Background: Endoscopic resectional techniques for colon cancer are undermined by their inability to determine lymph node status. This limits their application to only those lesions at the most minimal risk of lymphatic dissemination whereas their technical capacity could allow intraluminal or even transluminal address of larger lesions. Sentinel node biopsy may theoretically address this breach although the variability of its reported results for this disease is worrisome. Methods: Medline, EMBASE and Cochrane databases were interrogated back to 1999 to identify all publications concerning lymphatic mapping for colon cancer with reference cross-checking for completeness. All reports were examined from the perspective of in vivo technique accuracy selectively in early stage disease (i.e. lesions potentially within the technical capacity of endoscopic resection). Results: Fifty-two studies detailing the experiences of 3390 patients were identified. Considerable variation in patient characteristics as well as in surgical and histological quality assurances were however evident among the studies identified. In addition, considerable contamination of the studies by inclusion of rectal cancer without subgroup separation was frequent. Indeed such is the heterogeneity of the publications to date, formal meta-analysis to pool patient cohorts in order to definitively ascertain technique accuracy in those with T1 and/or T2 cancer is not possible. Although lymphatic mapping in early stage neoplasia alone has rarely been specifically studied, those studies that included examination of false negative rates identified high T3/4 patient proportions and larger tumor size as being important confounders. Under selected circumstances however the technique seems to perform sufficiently reliably to allow it prompt consideration of its use to tailor operative extent. Conclusion: The specific question of whether sentinel node biopsy can augment the oncological propriety for endoscopic resective techniques (including Natural Orifice Transluminal Endoscopic Surgery [NOTES]) cannot be definitively answered at present. Study heterogeneity may account for the variability evident in the results from different centers. Enhanced capacity (perhaps to the level necessary to consider selective avoidance of en bloc mesenteric resection) by its confinement to only early stage disease is plausible although not proven. Specific study of the technique in early stage tumors is clearly essential before proffering this approach.
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Dacron vs. PTFE as bypass materials in peripheral vascular surgery - systematic review and meta-analysis
Stephanie Roll, Jacqueline Muller-Nordhorn, Thomas Keil, Hans Scholz, Daniela Eidt, Wolfgang Greiner and Stefan N Willich Fri, 19 Dec 2008 00:00:00 -0000
Background: In peripheral vascular bypass surgery different synthetic materials are available for bypass grafting. It is unclear which of the two commonly used materials, polytetrafluoroethylene (PTFE) or polyester (Dacron(R)) grafts, is to be preferred. Thus, the aim of this meta-analysis and systematic review was to compare the effectiveness of these two prosthetic bypass materials (Dacron(R) and PTFE). Methods: We performed a systematic literature search in MEDLINE, Cochrane-Library - CENTRAL, EMBASE and other databases for relevant publications in English and German published between 1999 and 2008. Only randomized controlled trials were considered for inclusion. We assessed the methodological quality by means of standardized checklists. Primary patency was used as the main endpoint. Random-effect meta-analysis as well as pooling data in life table format was performed to combine study results. Results: Nine randomized controlled trials (RCT) were included. Two trials showed statistically significant differences in primary patency, one favouring Dacron(R) and one favouring PTFE grafts, while 7 trials did not show statistically significant differences between the two materials. Meta-analysis on the comparison of PTFE vs. Dacron(R) grafts yielded no differences with regard to primary patency rates (hazard ratio 1.04 (95% confidence interval [0.85;1.28]), no significant heterogeneity (p=0.32, I2=14%)). Similarly, there were no significant differences with regard to secondary patency rates. Conclusions: Systematic evaluation and meta-analysis of randomized controlled trials comparing Dacron(R) and PTFE as bypass materials for peripheral vascular surgery showed no evidence of an advantage of one synthetic material over the other.
Neoadjuvant chemoradiation followed by surgery versus surgery alone for patients with adenocarcinoma or squamous cell carcinoma of the esophagus (CROSS)
M van Heijl, JJB van Lanschot, LB Koppert, MI van Berge Henegouwen, K Muller, EW Steyerberg, H van Dekken, BPL Wijnhoven, HW Tilanus, DJ Richel, ORC Busch, JF Bartelsman, CCE Koning, GJ Offerhaus and A van der Gaast Wed, 26 Nov 2008 00:00:00 -0000
Background: A surgical resection is currently the preferred treatment for esophageal cancer if the tumor is considered to be resectable without evidence of distant metastases (cT1-3 N0-1 M0). A high percentage of irradical resections is reported in studies using neoadjuvant chemotherapy followed by surgery versus surgery alone and in trials in which patients are treated with surgery alone. Improvement of locoregional control by using neoadjuvant chemoradiotherapy might therefore improve the prognosis in these patients. We previously reported that after neoadjuvant chemoradiotherapy with weekly administrations of Carboplatin and Paclitaxel combined with concurrent radiotherapy nearly always a complete R0-resection could be performed. The concept that this neoadjuvant chemoradiotherapy regimen improves overall survival has, however, to be proven in a randomized phase III trial.Methods/designThe CROSS trial is a multicenter, randomized phase III, clinical trial. The study compares neoadjuvant chemoradiotherapy followed by surgery with surgery alone in patients with potentially curable esophageal cancer, with inclusion of 175 patients per arm.The objectives of the CROSS trial are to compare median survival rates and quality of life (before, during and after treatment), pathological responses, progression free survival, the number of R0 resections, treatment toxicity and costs between patients treated with neoadjuvant chemoradiotherapy followed by surgery with surgery alone for surgically resectable esophageal adenocarcinoma or squamous cell carcinoma. Over a 5 week period concurrent chemoradiotherapy will be applied on an outpatient basis. Paclitaxel (50 mg/m2) and Carboplatin (Area-Under-Curve = 2) are administered by i.v. infusion on days 1, 8, 15, 22, and 29. External beam radiation with a total dose of 41.4 Gy is given in 23 fractions of 1.8 Gy, 5 fractions a week. After completion of the protocol, patients will be followed up every 3 months for the first year, every 6 months for the second year, and then at the end of each year until 5 years after treatment. Quality of life questionnaires will be filled out during the first year of follow-up.DiscussionThis study will contribute to the evidence on any benefits of neoadjuvant treatment in esophageal cancer patients using a promising chemoradiotherapy regimen.Trial registrationISRCTN80832026
What happens to the external carotid artery following carotid endarterectomy?
Saleh M Abbas, David Adams and Peter Vanniasingham Tue, 25 Nov 2008 00:00:00 -0000
AimsThe effect of carotid endarterectomy on the patency of the external carotid artery is unknown. We conducted a retrospective study to evaluate the long-term changes in the external carotid artery following carotid endarterectomy. Methods: Data was prospectively recorded for all patients who had carotid endarterectomy between 1997 and 2006 in our vascular surgical unit. These patients had follow-up with carotid duplex ultrasound to assess the patency of the internal and external carotid artery. The data were retrieved and evaluated for patency and flow characteristic in both arteries before and after surgery. Results: Carotid endarterectomy was performed on 255 occasions in 236 patients over the ten year study period. Immediate and long-term outcome of carotid endarterectomy is comparable to results at other major centers. Stenosis of the external carotid artery as detected by duplex scan occurred in 5.5% of patients and was totally asymptomatic. Conclusion: Our results of carotid endarterectomy are comparable to other centers. Long-term follow up of the external carotid artery with duplex scan showed asymptomatic stenosis in a small percentage of patients.
Aortic replacement in aorto-occlusive disease: an observational study
Gareth Morris-Stiff, Samuel Ogunbiyi, Richard K Winter, Russell Brown and Michael H Lewis Fri, 31 Oct 2008 00:00:00 -0000
Background: For many patients with aorto-occlusive disease, where stent deployment is not possible, surgery remains the only treatment option available. The aim of this study was to assess the results of aortic reconstruction surgery performed in patients with critical ischaemia. Methods: All patients with critical ischaemia undergoing surgery during 1991–2004 were identified from a prospectively maintained database. Mortality data was verified against death certificate data. Demographic and clinical data were obtained from the clinical notes and the radiology database. Disease was classified as: type I – limited to aorta and common iliac arteries; type II – external iliac disease and type III combined aortic, iliac and infra-inguinal disease. Results: 86 patients underwent aortic replacement surgery all of whom had critical ischaemia consisting of: type I (n = 16); type II (n = 37) and type III (n = 33). The 30-day mortality rate was 10.4%, the one-year patient survival was 80%, and the 1-year graft survival was 80%. At 2 years the actual patient survival was 73% and no additional graft losses were identified. All patients surviving 30 days reported excellent symptomatic relief. Early, complications occurred in 6 (7%) patients: thrombosis within diseased superficial femoral arteries (n = 4); haemorrhage and subsequent death (n = 2). Ten (14%) late complications (> 12 months) occurred in the 69 surviving patients and included: anastomotic stenosis (n = 3); graft thrombosis (n = 4), graft infection (n = 3). Four patients developed claudication as a result of more distal disease in the presence of a patent graft, and 1 patient who continued smoking required an amputation for progressive distal disease. Conclusion: Aortic reconstruction for patients with extensive aorto-occlussive disease provides long-standing symptomatic relief for the majority of patients. After the first year, there is continued patient attrition due to co-existent cardiovascular disease but no further graft losses.
Clinical evaluation of an air-capsule technique for the direct measurement of intra-abdominal pressure after elective abdominal surgery
Jens Otto, Daniel Kaemmer, Andreas Biermann, Marc Jansen, Rolf Dembinski, Volker Schumpelick and Alexander Schachtrupp Fri, 17 Oct 2008 00:00:00 -0000
Background: The gold standard for assessment of intraabdominal pressure (IAP) is via intravesicular pressure measurement (IVP). This accepted technique has some inherent problems, e.g. indirectness. Aim of this clinical study was to assess direct IAP measurement using an air-capsule method (ACM) regarding complications risks and agreement with IVP in patients undergoing abdominal surgery. Methods: A prospective cohort study was performed in 30 patients undergoing elective colonic, hepatic, pancreatic and esophageal resection. For ACM a Probe 3 (Spiegelberg®, Germany) was placed on the greater omentum. It was passed through the abdominal wall paralleling routine drainages. To compare ACM with IVP t-testing was performed and mean difference as well as limits of agreement were calculated. Results: ACM did not lead to complications particularly with regard to organ lesion or surgical site infection. Mean insertion time of ACM was 4.4 days (min-max: 1–5 days). 168 pairwise measurements were made. Mean ACM value was 7.9 ± 2.7 mmHg while mean IVP was 8.4 ± 3.0 mmHg (n.s). Mean difference was 0.4 mmHg ± 2.2 mmHg. Limits of agreement were -4.1 mmHg to 5.1 mmHg. Conclusion: Using ACM, direct IAP measurement is feasible and uncomplicated. Associated with relatively low pressure ranges (<17 mmHg), results are comparable to bladder pressure measurement.
Could lymphatic mapping and sentinel node biopsy provide oncological providence for local resectional techniques for colon cancer? A review of the literature
Ronan A Cahill, Joel Leroy and Jacques Marescaux Wed, 24 Sep 2008 00:00:00 -0000
Background: Endoscopic resectional techniques for colon cancer are undermined by their inability to determine lymph node status. This limits their application to only those lesions at the most minimal risk of lymphatic dissemination whereas their technical capacity could allow intraluminal or even transluminal address of larger lesions. Sentinel node biopsy may theoretically address this breach although the variability of its reported results for this disease is worrisome. Methods: Medline, EMBASE and Cochrane databases were interrogated back to 1999 to identify all publications concerning lymphatic mapping for colon cancer with reference cross-checking for completeness. All reports were examined from the perspective of in vivo technique accuracy selectively in early stage disease (i.e. lesions potentially within the technical capacity of endoscopic resection). Results: Fifty-two studies detailing the experiences of 3390 patients were identified. Considerable variation in patient characteristics as well as in surgical and histological quality assurances were however evident among the studies identified. In addition, considerable contamination of the studies by inclusion of rectal cancer without subgroup separation was frequent. Indeed such is the heterogeneity of the publications to date, formal meta-analysis to pool patient cohorts in order to definitively ascertain technique accuracy in those with T1 and/or T2 cancer is not possible. Although lymphatic mapping in early stage neoplasia alone has rarely been specifically studied, those studies that included examination of false negative rates identified high T3/4 patient proportions and larger tumor size as being important confounders. Under selected circumstances however the technique seems to perform sufficiently reliably to allow it prompt consideration of its use to tailor operative extent. Conclusion: The specific question of whether sentinel node biopsy can augment the oncological propriety for endoscopic resective techniques (including Natural Orifice Transluminal Endoscopic Surgery [NOTES]) cannot be definitively answered at present. Study heterogeneity may account for the variability evident in the results from different centers. Enhanced capacity (perhaps to the level necessary to consider selective avoidance of en bloc mesenteric resection) by its confinement to only early stage disease is plausible although not proven. Specific study of the technique in early stage tumors is clearly essential before proffering this approach.
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