Safety and efficacy of tigecycline in treatment of skin and skin structure infections: results of a double-blind phase 3 comparison study with vancomycin-aztreonam

In a randomized, double-blind, controlled trial, 546 patients with complicated skin and skin structure infections received tigecycline 100 mg/day (a 100-mg initial dose and then 50 mg intravenously twice daily) or the combination of vancomycin 2 g/day (1 g intravenously twice daily) and aztreonam 4 g/day (2 g intravenously twice daily) for up to 14 days. The primary end point was the clinical response in the clinical modified intent-to-treat (c-mITT) and clinically evaluable (CE) populations at the test-of-cure visit 12 to 92 days after the last dose. The microbiologic response at the test-of-cure visit was also assessed. Safety was assessed by physical examination, laboratory results, and adverse event reporting. Five hundred twenty patients were included in the c-mITT population (tigecycline group, n = 261; combination group, n = 259), and 436 were clinically evaluable (tigecycline group, n = 223; combination group, n = 213). The clinical responses in the tigecycline and the combination vancomycin and aztreonam groups were similar in the c-mITT population (84.3% versus 86.9%; difference, -2.6% [95% confidence interval, -9.0, 3.8]; P = 0.4755) and the CE population (89.7% versus 94.4%; difference, -4.7% [95% confidence interval, -10.2, 0.8]; P = 0.1015). Microbiologic eradication (documented or presumed) occurred in 84.8% of the patients receiving tigecycline and 93.2% of the patients receiving vancomycin and aztreonam (difference, -8.5 [95% confidence interval, -16.0, -1.0]; P = 0.0243). The numbers of patients reporting adverse events were similar in the two groups, with increased nausea and vomiting rates in the tigecycline group and an increased incidence of rash and increases in alanine aminotransferase and aspartate aminotransferase levels in the combination vancomycin and aztreonam group. Tigecycline was shown to be safe and effective for the treatment of complicated skin and skin structure infections.     

Three-year results of randomised clinical trial comparing lightweight mesh with heavyweight mesh for inguinal hernioplasty

Purpose

The aim of the present randomised study was to find out whether usage of lightweight mesh in inguinal hernia repair, compared with heavyweight mesh, results in decreased incidence of chronic groin pain and foreign body feeling, as well as to evaluate the risk factors for chronic pain development and hernia recurrences.

Methods

The patients were randomised into the heavyweight mesh (HW) group and lightweight mesh (LW) group. A tension-free mesh repair using the Lichtenstein technique was performed on all patients. Pain scores during different activities were measured on visual analogue scale. All patients underwent a clinical examination for any evidence of hernia recurrence.

Results

Of the patients, 17.2?% in the HW group and 29.3?% in the LW group reported that they experienced pain at 3-year follow-up (P?=?0.1323). Pain was most often reported during physical activity. The median VAS score of all studied activities was 30.5 in the HW group and 30.0 in the LW group. There were more patients in the HW group than in the LW group who stated that they could feel the mesh in the groin (27.6 vs. 20.7?%, P?=?0.3967). Among all patients, 42.9?% who had severe pain preoperatively also reported pain during different activities and 19.6?% of the patients who did not have severe pain preoperatively reported pain during different activities (P?=?0.0481). At 3-year follow-up, there was 1 hernia recurrence in the HW group and 1 hernia recurrence in the LW group.

Conclusions

Our study shows that compared with HW mesh, LW mesh has no advantage in reducing chronic groin pain and foreign body feeling at the operation site after inguinal hernioplasty at 3-year follow-up. Severe preoperative pain was correlated with the development of chronic pain. There was no difference between the two study groups in the recurrence rates.     

Randomised clinical trial comparing lightweight mesh with heavyweight mesh for inguinal hernioplasty

Purpose  

The aim of the present randomised clinical study was to compare the incidence of post-operative chronic groin pain and the feeling of a foreign body after inguinal hernioplasty with lightweight (LW) and heavyweight (HW) mesh, as well as to evaluate the patient’s quality of life after inguinal hernia repair.     

Prospective study evaluating the impact of severity of chronic pain on quality of life after inguinal hernioplasty

Hernia - The definition of chronic pain after inguinal hernioplasty and the methods of its assessment vary a great deal, which make it complicated to conduct meta-analyses. The primary aim of the...     

Sugiura procedure in the treatment of bleeding esophageal varices.

AIM OF THE STUDY: The aim of this study was to report our results and to make an attempt to define the possible role of Sugiura procedure in the treatment of variceal bleeding. MATERIAL AND METHODS: From January 1979 to December 1997, 39 patients with portal hypertension and acute variceal bleeding (17 patients) or previous variceal bleeding (22 patients) underwent Sugiura procedure. Operations were performed in two stages. When performed in an emergency situation (17 patients) thoracic operation was performed first. In elective cases abdominal operation was usually preferred. Complete two-stage operation was performed in 16 patients. Twenty-three patients did not undergo the second stage because of early postoperative death, deterioration of condition or refusal. There were 17 men and 22 women, aged 41.7 +/- 18.3 years (range 8-71 years). According to the Child--Turcotte classification of hepatic function there were 23 Child class A, 13 Child class B and 3 Child class C patients. SUMMARY OF RESULTS: Overall operative mortality was 10.3% (4 deaths per 39 patients with 54 operations), mortality in an emergency situation was 17.6% (3 deaths per 17 patients) and in elective cases 4.3% (1 death per 22 patients with 37 operations). Variceal rebleeding occurred in 4 survivors (11.4%) at an average follow-up of 6.1 +/- 4.3 years. Survival rate was 84.6% at 1 year, 71.8% at 5 years and 64.1% at 10 years. CONCLUSIONS: Sugiura operation carries low operative risk in an elective situation and results in an effective prevention of recurrent variceal bleeding.     

Ligasure vessel sealing system versus conventional vessel ligation in thyroidectomy.

BACKGROUND AND AIMS: The Ligasure Vessel Sealing System (LVSS) is a new surgical technology which has been used to secure haemostasis in various fields of surgery. There is little information in the literature about the use of the LVSS in thyroid surgery and the results of these studies are controversial. The aim of this study was to report our experience with the LVSS in thyroid surgery and to compare it with our experience with conventional vessel ligation. PATIENTS AND METHODS: The non-randomized retrospective review included 403 consecutive patients who underwent primary thyroid surgery. A conventional suture-ligation technique was used in 199 patients (conventional group) and the LVSS was used in 204 patients (ligasure group). The following data were collected: patients' demographics, thyroid pathology, type of thyroidectomy, operating time and complications. RESULTS: The mean operating time for lobectomy, subtotal thyroidectomy and total thyroidectomy was significantly shorter in the Ligasure group compared with the conventional group. Average saving in operating time in the Ligasure group was 25.8 minutes (95% CI 19.5-32.2; p < 0.0001) with relative reduction being 26.6%. Among all types of complications only postoperative transient hypoparathyroidism demonstrated a significantly lower incidence in the Ligasure group (2.5% vs 7.0%; p = 0.022). CONCLUSIONS: We found that the LVSS is a safe method with minimal complications in thyroid surgery. Use of the LVSS for all types of thyroidectomy ensures a significantly shorter operating time.