Problems of randomization to open or laparoscopic sigmoidectomy for diverticular disease.

PURPOSE: Although complicated sigmoid diverticulitis is the most common reason for laparoscopic sigmoidectomy, the level of evidence for preference of the laparoscopic approach is low. METHODS: A multicenter, randomized clinical trial comparing laparoscopic and open sigmoidectomy for diverticulitis was conducted to evaluate the short- and mid-term outcome after both techniques. Data were assessed from randomized patients and from patients who refused randomization. Results of the here presented interim analysis describe the difficulties in randomization leading to abortion of recruitment. RESULTS: 149 patients were enrolled in the randomized trial within 36 months until the interim analysis. A further 294 nonrandomized patients who preferred one of both surgical approaches were assessed. Several differences between these groups were apparent including simple epidemiological characteristics such as age (65 vs. 60 years, p < 0.001), gender (65% vs. 55% female, p = 0.05), BMI (27 vs. 26 kg/m(2), p = 0.01), and ASA class < III (72% vs. 87%, p < 0.001). CONCLUSION: The majority of eligible patients refused a random allocation. A widespread presumption of the advantages of laparoscopic surgery was probably the main reason for refusal. Patients participating in randomization did not reflect the general population in recruiting hospitals. Future trials comparing minimal invasive procedures should be conducted before presumptions concerning the outcome are widespread in the general population.

A giant pancreatic serous microcystic adenoma with 20 years follow-up.

BACKGROUND AND AIMS: There is only little information about the spontaneous course of large pancreatic serous tumours. We followed up a white woman with a giant serous microcystic adenoma over more than 20 years. CASE REPORT: At first clinical presentation, in 1986, the tumour measured 4.5 cm in diameter. Two years later, it measured 6 cm and was considered as non-resectable at laparotomy. A biopsy was obtained, and the tumour was diagnosed as lymphangioma, based on hematoxylin and eosin-staining. During the follow-up, the tumour progressively increased in size, measuring 12 cm in diameter in 1993 and 17 cm in 2000. Thus, an average growth rate of 0.83 cm per year was calculated. Unspecific abdominal discomfort and pain were the leading clinical symptoms. A colonic resection was necessary because of compression by the tumour in 1993. Portal hypertension was detected at laparotomy. Finally, the initial biopsy specimen was re-evaluated, using immunohistochemistry, and the final diagnosis of a serous microcystic adenoma was made. CONCLUSION: This unique case demonstrates that the spontaneous course of serous microcystic adenoma of the pancreas may be favourable even with huge tumour size and that immunohistochemistry may prove a valuable tool for differential diagnosis of cystic pancreatic lesions. Due to their size and progressive, space-occupying growth, these biologically benign tumours may cause injury to adjacent organs and thus clinical symptoms. For this reason, curative surgical resection is the treatment of choice for this tumour entity except for small, asymptomatic lesions, which do not require intervention. When radical resection is impossible, palliative surgery may improve the quality of life for several years. The risk of malignant transformation seems to be low even in the long-term course.

Efficacy and safety of ertapenem versus piperacillin-tazobactam for the treatment of intra-abdominal infections requiring surgical intervention.

Complicated intra-abdominal infections usually mandate prompt surgical intervention supplemented by appropriate antimicrobial therapy. The aim of this study was to demonstrate that ertapenem was not inferior to piperacillin-tazobactam for the treatment of community-acquired intra-abdominal infections. A randomized open-label active-comparator clinical trial was conducted at 48 medical centers on four continents from December 2001 to February 2003. Adult patients with intra-abdominal infections requiring surgery were randomized to receive either ertapenem 1 g daily or piperacillin/tazobactam 13.5 g daily in 3-4 divided doses. The primary analysis of efficacy was the clinical response rate in clinically and microbiologically evaluable patients at the test-of-cure assessment 2 weeks after completion of therapy. All treated patients were included in the safety analysis. Patient demographics, disease characteristics, and treatment duration in both treatment groups were generally similar. The most commonly isolated pathogens at baseline were E coli (greater than 50% of cases in each group) and B fragilis ( approximately 9%). Favorable clinical response rates were 107/119 (90%) for ertapenem recipients and 107/114 (94%) for piperacillin/tazobactam recipients. The frequencies of drug-related adverse events, most commonly diarrhea and elevated serum alanine aminotransferase levels, were similar in both treatment groups. Six of 180 ertapenem recipients (3%) and two of 190 piperacillin/tazobactam recipients (1%) had serious drug-related adverse experiences. In this study, ertapenem and piperacillin/tazobactam were comparably safe and effective treatments for adult patients with complicated intra-abdominal infections.