Randomised clinical trial: mesalazine versus placebo in the prevention of diverticulitis recurrence.

BACKGROUND: Previous studies have reached conflicting conclusions regarding the efficacy of mesalazine in the prevention of recurrent diverticulitis. AIM: To investigate the efficacy and safety of mesalazine granules in the prevention of recurrence of diverticulitis after acute uncomplicated diverticulitis. METHODS: Two phase 3, randomised, placebo-controlled, double-blind multicentre trials (SAG-37 and SAG-51) investigated mesalazine granules in patients with prior episodes (<6 months) of uncomplicated left-sided diverticulitis. Patients were randomised to receive either 3 g mesalazine once daily or placebo (SAG-37, n=345) or to receive either 1.5 g mesalazine once daily, 3 g once daily or placebo for 96 weeks (SAG-51, n=330). The primary endpoint was the proportion of recurrence-free patients during 48 weeks (SAG-37 and SAG-51) or 96 weeks (SAG-51) of treatment. RESULTS: Mesalazine did not increase the proportion of recurrence-free patients over 48 or 96 weeks compared to placebo. In SAG-37, the proportion of recurrence-free patients during 48 weeks was 67.9% with mesalazine and 74.4% with placebo (P=.226). In SAG-51, the proportion of recurrence-free patients over 48 weeks was 46.0% with 1.5 g mesalazine, 52.0% with 3 g mesalazine and 58.0% with placebo (P=.860 for 3 g mesalazine vs placebo) and over 96 weeks 6.9%, 9.8% and 23.1% respectively (P=.980 for 3 g mesalazine vs placebo). Patients with only one diverticulitis episode in the year prior to study entry had a lower recurrence risk compared to >1 episode. Safety data revealed no new adverse events. CONCLUSION: Mesalazine was not superior to placebo in preventing recurrence of diverticulitis.

Prospective evaluation of complications in outpatient GI endoscopy: a survey among German gastroenterologists.

BACKGROUND: Although most diagnostic GI endoscopic procedures in Germany are performed on an outpatient basis, there is no large-scale prospective evaluation of complication rates. METHODS: Ninety-four gastroenterologists and internists from all regions of Germany recorded the number of EGD, colonoscopies, and polypectomies performed over a period of 1 year. All serious complications occurring in relation to the procedure, including the use of medication, were recorded in a structured protocol. RESULTS: A total of 110,469 EGDs, 82,416 colonoscopies, and 14,249 polypectomies were evaluated. The "reach-the-cecum-rate" was 97% (median). The overall complication rates for EGD, colonoscopy, and polypectomy were low compared with published data (0.009%, 0.02%, and 0.36%, respectively). The perforation rates were 0.0009%, 0.005%, and 0.06%, respectively, the rates of significant hemorrhage 0.002%, 0.001%, and 0.26%, respectively, and the mortality rates 0.0009%, 0.001%, and 0.007%, respectively. The rates of cardiorespiratory complications associated with EGD and colonoscopy were 0.005% and 0.01%, respectively. The overall complication rate for all procedures (diagnostic and therapeutic) was lower for gastroenterologists (1 per 5155 procedures) than internists (1 per 1539 procedures). Most of the adverse events associated with diagnostic endoscopy were attributable to use of medication. The severity score ranged from 2 to 5 for most of the adverse events occurring as a result of diagnostic procedures and 2 to 50 for polypectomy. The severity sum score per 10,000 procedures was 26 for EGD, 67 for colonoscopy, and 1185 for polypectomy. CONCLUSIONS: Outpatient endoscopy performed in practice settings by German gastroenterologists and internists is safe. The low complication rates may partly be explained by the high degree of experience resulting from the larger numbers of procedures performed relative to the numbers performed by gastroenterologists in hospitals and in other countries.

[Upper gastrointestinal bleeding as the first manifestation of a nonseminomatous testicular carcinoma]. / Obere gastrointestinale Blutung als Erstmanifestation eines nicht-seminomatösen Hodenkarzinoms.

HISTORY AND CLINICAL FINDINGS: For one week a 23-year-old man had been suffering from nausea and upper abdominal pain, followed by several bouts of haematemesis. On admission the haemoglobin level was 7.8 g/dl. INVESTIGATION: Endoscopy revealed a bleeding vessel stump at the posterior gastric wall: adrenaline was injected around it. A chest radiogram showed numerous round foci in the lung, while physical examination found gynaecomastia and changes in the left testis suspicious of tumour. beta-HCG (human chorionic gonadotrophin) activity was 230,000 U/l. TREATMENT AND COURSE: Histological examination of the immediately resected testis showed a necrotic non-seminomatous germ cell tumor (pT1N2M1). Repeat gastroscopy because of renewed tarry stools and haematemesis revealed bleeding from an area of polypoid mucosa. At laparotomy the lesion was excised. Histologically it was a submucosal metastasis of the testicular carcinoma. Chemotherapy resulted in normalisation of the beta-HCG-level. Subsequently retroperitoneal lymphadenectomy and bilateral thoracotomy with resection of residual tumour tissue were performed: no active tumour was found histologically. There has been no sign of tumour recurrence after 56 months. CONCLUSION: Upper gastrointestinal bleeding from a haematogenous metastasis is a very rare initial manifestation of a testicular carcinoma. But a malignant tumour should be thought of in a young patient with unexplained haematemesis.