Journal of surgical oncology
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Randomized Controlled Trial Multicenter Study
Cosmetic outcome and quality of life are inextricably linked in breast-conserving therapy.
Cosmetic results and quality of life (QoL) are increasingly important in the treatment of breast cancer. This study was designed to determine the relationship between QoL and both subjectively and objectively measured cosmetic outcomes of breast-conserving therapy (BCT), and its course over time. ⋯ There is a high correlation between poor cosmetic outcome and low scores on quality of life indicators, underlining the importance of achieving a good cosmetic outcome after BCT.
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Randomized Controlled Trial
Randomized clinical trial to assess the efficacy of ulinastatin for postoperative pancreatitis following pancreaticoduodenectomy.
Ulinastatin, an intrinsic trypsin inhibitor, has proved to be effective for the prevention of acute pancreatitis after endoscopic retrograde cholangiopancreatography. The aim of this study was to assess the efficacy of ulinastatin for postoperative pancreatitis following pancreaticoduodenectomy in a randomized clinical trial. ⋯ Prophylactic administration of ulinastatin reduced the levels of serum and drain amylase and the incidence of postoperative pancreatitis following pancreaticoduodenectomy.
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Randomized Controlled Trial Clinical Trial
Randomised phase 2 trial of SIR-Spheres plus fluorouracil/leucovorin chemotherapy versus fluorouracil/leucovorin chemotherapy alone in advanced colorectal cancer.
Selective internal radiation therapy (SIRT) with SIR-Spheres(R) is a new technique for selectively targeting high doses of radiation to tumours within the liver. The primary objectives of this randomised trial were to compare the response rate, time to progressive disease (PD), and toxicity of a regimen of systemic fluorouracil/leucovorin chemotherapy versus the same chemotherapy plus a single administration of SIR-Spheres in patients with advanced colorectal liver metastases. The trial was designed to presage a larger trial that would have survival as the primary outcome. ⋯ This small phase 2 randomised trial demonstrated that the addition of a single administration of SIR-Spheres to a regimen of systemic fluorouracil/leucovorin chemotherapy significantly increased both treatment related response, time to PD, and survival with acceptable toxicity. The combination of SIR-Spheres plus systemic chemotherapy is now the subject of ongoing trials to further define patient benefit.
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Randomized Controlled Trial Comparative Study Clinical Trial
Randomised clinical trial of adjuvant postoperative RT vs. sequential postoperative RT plus 5-FU and levamisole in patients with stage II-III resectable rectal cancer: a final report.
A randomised clinical trial was performed in patients undergoing radical surgery for rectal cancer to compare the efficacy and toxicity of adjuvant postoperative radiation therapy (RT) to sequential RT and chemotherapy (CT) with 5-fluorouracil (5-FU) plus levamisole (LEV). The primary end point was overall survival (OS); secondary end points were disease-free survival (DFS), the rate of loco-regional recurrence, and treatment-related toxicity; the final results of this trial are reported. ⋯ Our findings suggest no difference in OS, loco-regional and distant site progressions of postoperative RT alone compared to sequential postoperative RT and CT; notably, this latter regimen was associated with higher toxicity which seriously impaired the patient's compliance to CT. The low loco-regional recurrence rate (9.2%) observed in our patients undergoing postoperative RT alone compared to similarly treated patients in previously performed clinical trials (20-25%) underline the role of radical surgery (mesorectal excision) coupled with a complete postoperative RT regimen. On the other hand, the similar efficacy of these two adjuvant modalities of treatment might be conditioned by both the low compliance (59%) to the CT regimen as well as the sequential, instead of concurrent, schedule of administration of RT and CT, which may have decreased further the expected efficacy of the combined regimen.
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Randomized Controlled Trial Clinical Trial
Choice of route for central venous cannulation: subclavian or internal jugular vein? A prospective randomized study.
The clinical need for central venous cannulation has been well established. The usual route for catheter placement is by either the subclavian or internal jugular vein. ⋯ One hundred consecutive patients requiring elective central venous cannulation were randomized to either the subclavian or internal jugular route. Successful venipuncture and catheter passage were significantly more common with the subclavian route, and in the absence of special clinical situations, it appears to be the route of choice.