Health-related quality of life after laparoscopic and open surgery for rectal cancer in a randomized trial

BACKGROUND: Previous studies comparing laparoscopic and open surgical techniques have reported improved health-related quality of life (HRQL). This analysis compared HRQL 12 months after laparoscopic versus open surgery for rectal cancer in a subset of a randomized trial. METHODS: The setting was a multicentre randomized trial (COLOR II) comparing laparoscopic and open surgery for rectal cancer. Involvement in the HRQL study of COLOR II was optional. Patients completed the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and QLQ-CR38, and EuroQol – 5D (EQ-5D™) before surgery, and 4 weeks, 6, 12 and 24 months after operation. Analysis was done according to the manual for each instrument. RESULTS: Of 617 patients in hospitals participating in the HRQL study of COLOR II, 385 were included. The HRQL deteriorated to moderate/severe degrees after surgery, gradually returning to preoperative values over time. Changes in EORTC QLQ-C30 and QLQ-CR38, and EQ-5D™ were not significantly different between the groups regarding global health score or any of the dimensions or symptoms at 4 weeks, 6 or 12 months after surgery. CONCLUSION: In contrast to previous studies in patients with colonic cancer, HRQL after rectal cancer surgery was not affected by surgical approach. Registration number: NCT0029779 (http://www.clinicaltrials.gov)

Post traumatic intra thoracic spleen presenting with upper GI bleed! – a case report

<p>Abstract</p> <p>Background</p> <p>Isolated splenic vein thrombosis with left sided portal hypertension is a rare cause of upper gastrointestinal bleed. Diagnosis is difficult and requires a high index of suspicion, especially in patients presenting with gastrointestinal bleed in the presence of splenomegaly and normal liver function tests.</p> <p>Case presentation</p> <p>A 64 year old male presented with haematemesis and melaena. An upper gastrointestinal endoscopy revealed the presence of antral erosions in the stomach and fundal varices. A computerised tomography scan of abdomen confirmed the presence of a diaphragmatic tear and the spleen to be lying in the left hemi thorax. The appearances of the splenic vein on the scan were consistent with thrombosis.</p> <p>Conclusion</p> <p>Left sided portal hypertension as a result of isolated splenic vein thrombosis secondary to trauma is rare. The unusual presentation of our case, splenic herniation into the left hemithorax, causing fundal varices leading to upper gastrointestinal bleed 28 years after the penetrating injury, makes this case most interesting. We believe that this has not been reported in literature before.</p

Safety assessment of new antithrombotic agents: lessons from the EXTEND study on ximelagatran

BACKGROUND: Ximelagatran, the first oral direct thrombin inhibitor, was shown to be an effective antithrombotic agent but was associated with potential liver toxicity after prolonged administration. OBJECTIVES AND METHODS: The aim of the EXTEND study was to assess safety and efficacy of extended administration (35 days) of ximelagatran or enoxaparin for the prevention of venous thromboembolism after elective hip replacement and hip fracture surgery. A follow-up period, including assessment of liver enzymes (in particular alanine aminotransferase; ALAT), until post-operative day 180 was planned, with visits at days 56 and 180. RESULTS: Randomization and administration of study drugs were stopped following a report of serious liver injury occurring 3 weeks after completion of ximelagatran treatment. At the time of study termination, 1158 patients had been randomized and 641 had completed the 35-day treatment; with 303 ximelagatran and 265 enoxaparin patients remaining in the study through to the day 56 follow-up visit. Overall, 58 patients showed an ALAT increase to >2x upper limit of normal: 31 treated with enoxaparin, 27 with ximelagatran. Three ximelagatran patients also showed symptoms potentially related to liver toxicity. Eleven ximelagatran patients showed an ALAT increase after study treatment ended. The clinical development of ximelagatran was terminated and the drug withdrawn from the market. Evaluation of the relative efficacy of the two treatments as specified in the protocol was impossible due to the premature termination of the study. CONCLUSIONS: Prolonged administration of ximelagatran was associated with an increased risk of liver toxicity. In a substantial proportion of patients, ALAT increase occurred after treatment withdrawal. The findings seen with ximelagatran should be considered when designing studies with new antithrombotic agent

Cytokine modulation by PX differently affects specific acute phase proteins during sepsis in rats

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Oral, direct Factor Xa inhibition with BAY 59-7939 for the prevention of venous thromboembolism after total hip replacement

Background: Joint replacement surgery is an appropriate model for dose-ranging studies investigating new anticoagulants. Objectives: To assess the efficacy and safety of a novel, oral, direct factor Xa (FXa) inhibitor - BAY 59-7939 - relative to enoxaparin in patients undergoing elective total hip replacement. Methods: In this double-blind, double-dummy, doseranging study, patients were randomized to oral BAY 59-7939 (2.5, 5, 10, 20, or 30 mg b.i.d.), starting 6-8 h after surgery, or s.c. enoxaparin 40 mg once daily, starting on the evening before surgery. Treatment was continued until mandatory bilateral venography was performed 5-9 days after surgery. Results: Of 706 patients treated, 548 were eligible for the primary efficacy analysis. The primary efficacy endpoint was the incidence of any deep vein thrombosis, non-fatal pulmonary embolism, and all cause mortality; rates were 15%, 14%, 12%, 18%, and 7%for BAY 59-7939 2.5, 5, 10, 20, and 30 mg b.i.d., respectively, compared with 17% for enoxaparin. The primary efficacy analysis did not demonstrate any signi.cant trend in dose-response relationship for BAY 59-7939. The primary safety endpoint was major, postoperative bleeding; there was a significant increase in the frequency of events with increasing doses of BAY 59-7939 (P = 0.045), but no signi.cant di.erences between individual BAY 59-7939 doses and enoxaparin. Conclusions: When eficacy and safety were considered together, compared favorably with enoxaparin for the prevention of venous thromboembolism in patients undergoing elective total hip replacement. \ua9 2006 International Society on Thrombosis and Haemostasis