Daily treatment with esomeprazole is superior to that taken on-demand for maintenance of healed erosive oesophagitis.

BACKGROUND: On-demand therapy with esomeprazole is effective for long-term treatment of non-erosive gastro-oesophageal reflux disease, but it has not been evaluated in erosive gastro-oesophageal reflux disease. AIMS: To compare endoscopic and symptomatic remission over a 6-month period when patients with healed erosive gastro-oesophageal reflux disease are treated with esomeprazole 20 mg, either once daily or on-demand. METHODS: Patients with verified erosive reflux oesophagitis of Los Angeles grades A-D were enrolled. Following 4-8 weeks treatment with esomeprazole 40 mg daily, those who were endoscopically healed and had symptom control during the last week were randomized to maintenance therapy for 6 months with esomeprazole 20 mg, taken either once daily or on-demand. RESULTS: Of 539 enrolled patients, 494 (91%) were healed at 8 weeks and 477 were randomized to maintenance therapy with esomeprazole 20 mg, 243 once daily and 234 on-demand. After once daily treatment, 81% of patients were still in remission at 6 months, compared with only 58% who took on-demand treatment (P < 0.0001). A difference in remission was found irrespective of baseline grade of oesophagitis, but it was more pronounced for the more severe grades. There was no difference in overall symptomatic remission between the two treatments, although heartburn was significantly more prevalent in the on-demand group. CONCLUSIONS: Once daily esomeprazole 20 mg was better than that taken on-demand for maintaining healed erosive oesophagitis, regardless of baseline Los Angeles grade.

Do Japanese and Swedish peptic ulcer patients respond differently to Helicobacter pylori eradication therapies and what are their histological features?

BACKGROUND: As a consequence of gastric histological differences, Japanese and Swedish peptic ulcer (PU) patients may respond differently to Helicobacter pylori eradication therapies. METHODS: The study was single-blind and compared four eradication therapies in Japanese and Swedish patients with healed gastric (GU) or duodenal (DU) ulcer. Swedish patients received either (a) omeprazole+clarithromycin (OC, where O = 20 mg, C = 500 mg) for 2 weeks, or triple therapy with (b) omeprazole + amoxicillin + clarithromycin (OAC-L where O = 20mg, A = 1 g, C = 250 mg); (c) OAC-H (where O = 20 mg, A-1 g, C-500 mg); or (d) omeprazole + metronidazole + clarithromycin (OMC, where O = 20 mg, M = 400 mg, C = 250 mg) for 1 week. Antibiotic doses were weight-adjusted downwards in Japanese patients. H. pylori was assessed using the urea breath test (UBT), histology and culture pre-entry, with UBT being repeated 4 and 8 weeks after stopping treatment. Histology and culture were repeated if the UBT was positive post-therapy. RESULTS: Recruitment included 120 patients from Japan (43 GU, 61 DU, 16 GU+DU) and 120 from Sweden (119 DU, 1 GU+DU). There were 26 exclusions from a FAS analysis due to H. pylori negativity (14), no drug administration (7) or no data after visit 1 (5). Eradication rates (FAS) from Japan were (a) 63%, (b) 93%, (c) 96% or (d) 96%, and for Sweden (a) 92%, (b) 86%, (c) 93% or (d) 96%. Dual therapy was less effective in patients with gastric atrophy associated with GU disease. Tolerability was good in all treatment groups, with no serious adverse events. CONCLUSION: Triple therapies were safe and effective for H. pylori eradication in Japanese and Swedish peptic ulcer patients. Dual therapy was significantly less effective in the Japanese patients, half of whom had a history of GU and more abnormal histology than in the Swedish patients, all of whom had DU.

Comparison of gastric histology among Swedish and Japanese patients with peptic ulcer and Helicobacter pylori infection.

BACKGROUND: The natural course of Helicobacter pylori gastritis may vary between different ethnic groups. Gastric histopathology and the occurrence of H. pylori organisms in the stomach were investigated in healed duodenal (DU) and gastric (GU) ulcer patients recruited in Sweden (S) and Japan (J) in an identical trial. METHODS: In 203 patients (JGU = 39, JDU = 55, SDU = 109), various morphological gastritis variables and H. pylori were assessed from biopsy specimens obtained using a specific sampling protocol and interpreted according to guidelines of the updated Sydney grading system. RESULTS: The ratio of GU:DU was observed to be very different between the recruited Japanese (39:55) and Swedish (0:109) patients. A comparison of data from SDU and JDU showed that the prevalence of H. pylori infection and the antral predominant gastritis demonstrated by both SDU and JDU were essentially identical. A comparison of data from JDU and JGU demonstrated a greater prevalence of H. pylori infection in the antrum, but not corpus, of JDU compared to JGU patients. The prevalence of atrophy and intestinal metaplasia was higher in both the antrum and corpus of JGU compared to JDU in all patients. CONCLUSIONS: The site specified biopsy methodology and standardized interpretation criteria utilized in this study clearly show that the histotopographic profile of Swedish and Japanese DU patients is essentially the same.

One-week esomeprazole treatment: an effective confirmatory test in patients with suspected gastroesophageal reflux disease.

BACKGROUND: Symptomatic response to acid inhibition can be used as a guide in diagnosing patients with reflux symptoms. The proton-pump inhibitor (PPI) omeprazole has been used as such a diagnostic tool. Intragastric acid control with esomeprazole is more effective than other PPIs and has the potential to offer an advance in the diagnostic use of PPIs. METHODS: Patients experiencing heartburn (for > or = 6 months) were studied in this randomized, double-blind, multicenter study. Following a 3-day placebo run-in, 440 patients were randomized to 14 days' treatment with esomeprazole 40 mg once daily (o.d.), esomeprazole 20 mg twice daily (b.i.d.) or placebo. Heartburn symptoms were recorded daily. Endoscopy and 24-h esophageal pH-monitoring were performed to determine the presence of gastroesophageal reflux disease (GERD). The esomeprazole treatment test was considered positive if patients' symptoms improved during the treatment period compared with symptoms recorded on Day 0. RESULTS: 63 patients were excluded from the analysis due to lack of symptoms on Day 0 or failure to complete pH-monitoring. The sensitivity of an esomeprazole treatment test in confirming GERD increased during the first days of treatment and stabilized between 79% and 86% after 5 days (both esomeprazole arms). The corresponding figure for the placebo arm was 36%. Specificity was variable (24%-65%) for both active treatment and placebo. CONCLUSION: A treatment test with esomeprazole 40 mg has a high sensitivity in confirming GERD. Furthermore, the data indicate that 1-week treatment with a once-daily dosage is sufficient to ensure adequate diagnosis.

Comparison of Gastric Histology Among Swedish and Japanese Patients with Peptic Ulcer and <emph type="2">Helicobacter pylori</emph> Infection.

BACKGROUND: The natural course of Helicobacter pylori gastritis may vary between different ethnic groups. Gastric histopathology and the occurrence of H. pylori organisms in the stomach were investigated in healed duodenal (DU) and gastric (GU) ulcer patients recruited in Sweden (S) and Japan (J) in an identical trial. METHODS: In 203 patients (JGU = 39, JDU = 55, SDU = 109), various morphological gastritis variables and H. pylori were assessed from biopsy specimens obtained using a specific sampling protocol and interpreted according to guidelines of the updated Sydney grading system. RESULTS: The ratio of GU:DU was observed to be very different between the recruited Japanese (39:55) and Swedish (0:109) patients. A comparison of data from SDU and JDU showed that the prevalence of H. pylori infection and the antral predominant gastritis demonstrated by both SDU and JDU were essentially identical. A comparison of data from JDU and JGU demonstrated a greater prevalence of H. pylori infection in the antrum, but not corpus, of JDU compared to JGU patients. The prevalence of atrophy and intestinal metaplasia was higher in both the antrum and corpus of JGU compared to JDU in all patients. CONCLUSIONS: The site specified biopsy methodology and standardized interpretation criteria utilized in this study clearly show that the histotopographic profile of Swedish and Japanese DU patients is essentially the same.

Effect of profound acid suppression in functional dyspepsia: a double-blind, randomized, placebo-controlled trial.

BACKGROUND: Functional dyspepsia (FD) is defined as persistent or recurrent pain/discomfort centred in the upper abdomen, where no structural explanation for the symptoms is found. The role of drug treatment remains controversial. The aim in this study was to evaluate the effect of omeprazole 20 mg twice daily (b.i.d) and to test methods for symptom assessment. METHODS: 197 patients fulfilling the criteria for FD were randomly allocated to double-blind treatment with omeprazole 20 mg b.i.d (n = 100) or placebo (n = 97) for 14 days. Patients with a known gastrointestinal disorder or with main symptoms indicating gastro-oesophageal reflux disease or irritable bowel syndrome were excluded. Helicobacter pylori testing and 24-h intra-oesophageal 24-h pH-metry were performed before randomization. The patients recorded dyspeptic symptoms on diary cards. RESULTS: A stringent endpoint, 'complete symptom relief on the last day of treatment', was the primary efficacy variable. For the APT cohort, this was achieved in 29.0% and 17.7% on omeprazole and placebo, respectively (95% CI of difference (11.3%): -0.4%-23.0%, P = 0.057). Similar figures in the PP cohort were 31.0% and 15.5%, respectively (95% Cl of difference (15.5%): 3.2%-27.7%, P = 0.018). The benefit of omeprazole in the PP cohort was confirmed by secondary endpoints such as, no dyspeptic symptoms on the last 2 days of treatment and overall treatment response. H. pylori status and the level of oesophageal acid exposure did not significantly influence the response to therapy. CONCLUSION: A subset of patients with FD will respond to therapy with omeprazole.

One-week triple therapy with esomeprazole provides effective eradication of Helicobacter pylori in duodenal ulcer disease.

BACKGROUND: Esomeprazole is the first proton pump inhibitor to be developed as an optical isomer for the treatment of acid-related diseases. METHODS: Four hundred and forty eight duodenal ulcer patients with Helicobacter pylori infection, confirmed by 13C-urea breath test (UBT), and no current ulcer, were randomised to double-blind treatment with esomeprazole 20 mg twice daily (b.d.) (n=224) or omeprazole 20 mg b.d. (n=224), in combination with amoxicillin 1 g b.d. and clarithromycin 500 mg b.d. for 1 week (EAC and OAC, respectively). A negative UBT at both 4 and 8 weeks after completing therapy indicated successful H. pylori eradication. RESULTS: Intention-to-treat (ITT) analysis comprised 400 patients (EAC, n=204; OAC, n=196) and per protocol (PP) analysis 377 patients (EAC, n=192; OAC, n=185). Eradication rates (95% confidence intervals) for ITT and PP populations were: EAC, 90% (85-94%) and 91% (86-94%); OAC, 88% (82-92%) and 91% (86-95%). Between-group differences in eradication rates were not statistically significant. Both regimens were well tolerated, with an adverse event profile and frequency typical of proton pump inhibitor plus antibiotic combination therapy. CONCLUSIONS: Esomeprazole-based triple therapy for 1 week is highly effective in eradicating H. pylori infection in duodenal ulcer disease, offers comparable efficacy to omeprazole-based therapy, and is well tolerated.

The HOMER Study: the effect of increasing the dose of metronidazole when given with omeprazole and amoxicillin to cure Helicobacter pylori infection.

BACKGROUND: Helicobacter pylori eradication with omeprazole, amoxycillin, and metronidazole is both effective and inexpensive. However, eradication rates with different dosages and dosing vary, and data on the impact of resistance are sparse. In this study, three different dosages of omeprazole, amoxycillin, and metronidazole were compared, and the influence of metronidazole resistance on eradication was assessed. METHODS: Patients (n = 394) with a positive H. pylori screening test result and endoscopy-proven duodenal ulcer in the past were enrolled into a multicenter study performed in four European countries and Canada. After baseline endoscopy, patients were randomly assigned to treatment for 1 week with either omeprazole, 20 mg twice daily, plus amoxycillin, 1,000 mg twice daily, plus metronidazole, 400 mg twice daily (low M); or omeprazole, 40 mg once daily, plus amoxycillin, 500 mg three times daily, plus metronidazole, 400 mg three times daily (medium M); or omeprazole, 20 mg twice daily, plus amoxycillin, 1,000 mg twice daily, plus metronidazole, 800 mg twice daily (high M). H. pylori status at entry was assessed by a 13C urea breath test and a culture. Eradication was defined as two negative 13C-urea breath test results 4 and 8 weeks after therapy. Susceptibility testing using the agar dilution method was performed at entry and in patients with persistent infection after therapy. RESULTS: The eradication rates, in terms of intention to treat (ITT) (population n = 379) (and 95% confidence interval [CI]) were as follows: low M 76% (68%, 84%), medium M 76% (68%, 84%), and high M 83% (75%, 89%). By per-protocol analysis (population n = 348), the corresponding eradication rates were: low M 81%, medium M 80%, and high M 85%. No H. pylori strains were found to be resistant to amoxycillin. Prestudy resistance of H. pylori strains to metronidazole was found in 72 of 348 (21%) of the cultures at entry (range, 10%-39% in the five countries). The overall eradication rate in prestudy metronidazole-susceptible strains was 232 of 266 (87%) and, for resistant strains, it was 41 of 70 (57%; p <.001). Within each group, the results were as follows (susceptible/resistant): low M, 85%/54%; medium M, 86%/50%; and high M, 90%/75%. There were no statistically significant differences among the treatment groups. 23 strains susceptible to metronidazole before treatment were recultured after therapy failed; 20 of these had now developed resistance. CONCLUSIONS: H. pylori eradication rates were similar (approximately 80%) with all three regimens. Metronidazole resistance reduced efficacy; increasing the dose of metronidazole appeared not to overcome the problem or significantly improve the outcome. Treatment failure was generally associated with either prestudy or acquired metronidazole resistance. These findings are of importance when attempting H. pylori eradication in communities with high levels of metronidazole resistance.

Quality of life in patients with heartburn but without esophagitis: effects of treatment with omeprazole.

OBJECTIVE: Because improvement in quality of life (QoL) is an important therapeutic goal in patients with heartburn but without esophagitis, the aim of the present study was to compare the impact of omeprazole 20 mg or 10 mg daily with that of placebo on QoL in patients with heartburn as the predominant symptom. METHODS: QoL was measured at baseline and after 4 wk using two validated questionnaires, the Psychological General Well-Being (PGWB) index and the Gastrointestinal Symptom Rating Scale. RESULTS: The two questionnaires were completed by 163 patients in the omeprazole 20 mg group, 163 in the omeprazole 10 mg group, and 82 in the placebo group. The reflux dimension of the Gastrointestinal Symptom Rating Scale showed a significant improvement in terms of reflux symptoms on omeprazole 20 mg versus omeprazole 10 mg and placebo, and on omeprazole 10 mg compared with placebo. The total score of the PGWB index improved significantly more on both doses of omeprazole than on placebo. The mean scores rose from 96.8 to 103.9 on omeprazole 20 mg, from 98.4 to 106.0 on omeprazole 10 mg, and from 98.0 to 100.6 on placebo. All dimensions of the PGWB index improved on treatment with omeprazole, but the improvements were most pronounced in the dimensions depicting anxiety, depressed mood, and self-control. CONCLUSIONS: It is concluded that treatment with omeprazole 20 mg and omeprazole 10 mg restores QoL to a level comparable with that observed in a healthy population.

On demand therapy with omeprazole for the long-term management of patients with heartburn without oesophagitis--a placebo-controlled randomized trial.

AIM: To observe the natural course of gastro-oesophageal reflux disease (GERD) in patients without oesophagitis following effective symptom relief, and to determine the place of acid pump inhibitor therapy in the long-term management of these patients. METHODS: We investigated the efficacy of on-demand therapy with omeprazole 20 mg or 10 mg, or placebo in a double-blind, randomized multicentre trial. It involved 424 patients with troublesome heartburn without endoscopic evidence of oesophagitis in whom heartburn had been resolved with short-term treatment. Patients were told to take study medication on demand once daily on recurrence of symptoms until symptoms resolved over a 6-month period. They also had access to antacids. The primary efficacy variable was time to discontinuation of treatment, due to unwillingness to continue. RESULTS: According to life-table analysis, after 6 months the remission rates were 83% (95% CI: 77-89%) with omeprazole 20 mg, 69% (61-77%) with omeprazole 10 mg, and 56% (46-64%) with placebo (P < 0.01 for all intergroup differences). The mean (s.d.) number of study medications used per day in these groups was 0.43 (0.27), 0.41 (0.27) and 0.47 (0.27), respectively. The use of antacids was highest in the placebo group and lowest in the omeprazole 20 mg group. Treatment failure was associated with more than a doubling of antacid use, and a deterioration in patient quality of life. CONCLUSIONS: Approximately 50% of patients with heartburn who do not have oesophagitis need acid inhibitory therapy in addition to antacid medication to maintain a normal quality of life. On-demand therapy with omeprazole 20 mg, is an effective treatment strategy in these patients.

Lack of effect of treating Helicobacter pylori infection in patients with nonulcer dyspepsia. Omeprazole plus Clarithromycin and Amoxicillin Effect One Year after Treatment (OCAY) Study Group.

BACKGROUND: It is uncertain whether treatment of Helicobacter pylori infection relieves symptoms in patients with nonulcer, or functional, dyspepsia. METHODS: We conducted a double-blind, multicenter trial of patients with H. pylori infection and dyspeptic symptoms (moderate-to-very-severe pain and discomfort centered in the upper abdomen). Patients were excluded if they had a history of peptic ulcer disease or gastroesophageal reflux disease and had abnormal findings on upper endoscopy. Patients were randomly assigned to seven days of treatment with 20 mg of omeprazole twice daily, 1000 mg of amoxicillin twice daily, and 500 mg of clarithromycin twice daily or with omeprazole alone and then followed up for one year. Treatment success was defined as the absence of dyspeptic symptoms or the presence of minimal symptoms on any of the 7 days preceding the 12-month visit. RESULTS: Twenty of the 348 patients were excluded after randomization because they were not infected with H. pylori, were not treated, or had no data available. For the remaining 328 patients (164 in each group), treatment was successful for 27.4 percent of those assigned to receive omeprazole and antibiotics and 20.7 percent of those assigned to receive omeprazole alone (P=0.17; absolute difference between groups, 6.7 percent; 95 percent confidence interval, -2.6 to 16.0). After 12 months, gastritis had healed in 75.0 percent of the patients in the group given omeprazole and antibiotics and in 3.0 percent of the patients in the omeprazole group (P<0.001); the respective rates of H. pylori eradication were 79 percent and 2 percent. In the group given omeprazole and antibiotics, the rate of treatment success among patients with persistent H. pylori infection was similar to that among patients in whom the infection was eradicated (26 percent vs. 31 percent). There were no significant differences between the groups in the quality of life after treatment. CONCLUSIONS: In patients with nonulcer dyspepsia, the eradication of H. pylori infection is not likely to relieve symptoms.

Lansoprazole and omeprazole in the prevention of relapse of reflux oesophagitis: a long-term comparative study.

BACKGROUND: Proton pump inhibitors are superior to H2-receptor antagonists in the prevention of relapse of oesophagitis, but few data directly compare the relative efficacies of lansoprazole and omeprazole in preventing oesophagitis relapse over a prolonged period. METHODS: Patients with healed Grade II, III or IV oesophagitis were treated with lansoprazole 30 mg o.d. or omeprazole 20 mg o.d. for 48 weeks. Endoscopy and symptom assessment were performed after 12. 24 and 48 weeks of treatment and an additional symptom assessment 36 weeks after starting treatment. RESULTS: Intention-to-treat analysis included 248 patients (lansoprazole n = 126, omeprazole n = 122). Comparison of time to endoscopic and/or symptomatic relapse revealed no difference between the treatments. There was no significant difference between treatments with respect to the proportion of patients in whom endoscopic and/or symptomatic relapse was reported (lansoprazole 12/126 (9.5%), omeprazole 11/122 (9.0%)). No difference between the treatments in either the number or severity of adverse events was reported. CONCLUSIONS: Continuous treatment with either lansoprazole 30 mg or omeprazole 20 mg is effective in preventing the relapse of oesophagitis over a 48-week period in a majority of patients. Both treatments exhibit a similar side-effect profile.

Reoperation as surrogate endpoint in hernia surgery. A three year follow-up of 1565 herniorrhaphies.

OBJECTIVE: Analysis of reoperation and recurrence rates three years after repair of groin hernias. DESIGN: Prospective audit by questionnaire and selective follow-up. SETTING: Eight Swedish hospitals. SUBJECTS: All groin hernia operations done during 1992 on patients between the ages of 15 and 80 years. MAIN OUTCOME MEASURES: Postoperative complications, reoperation for recurrence, and recurrence. RESULTS: During 1992, 1565 hernia operations were done. The postoperative complication rate was 8% (125/1565). At 36 months postoperatively 108 recurrences had already been reoperated on, six patients with recurrences were on the waiting list for reoperation and a further 36 recurrences had been detected at follow-up. The interhospital variation in recurrence rate ranged from 3% to 20%. Postoperative complications, recurrent hernia, direct hernia and hospital catchment area over 100000 inhabitants were all factors associated with an increased relative risk of recurrence. CONCLUSIONS: The recurrence rate exceeded the reoperation rate for recurrence by almost 40% which should be taken into account if the reoperation rate is used as the endpoint after repairs of groin hernia. An audit scheme, based on prospective recording, reoperation rate, and (periodic) calculation of the recurrence rate may be used to identify risk factors for recurrence and areas in need of improvement.

Hernia surgery in a defined population: a prospective three year audit.

OBJECTIVE: To establish a register of inguinal hernia surgery that allows audit and analyses of data from several centres. DESIGN: Prospective recording of data on a common protocol. SETTING: Eight Swedish hospitals. SUBJECTS: All groin hernia operations done for patients over 15 years old from January 1992 to December 1994. MAIN OUTCOME MEASURES: Methods of repair, postoperative complications including mortality, day surgery rate, and reoperations for recurrence. RESULTS: During the three years studied 4879 hernia operations were undertaken in 4474 patients. Postoperative mortality within 30 days of operation for emergency and elective hernia repairs was 3.5% and 0.07%, respectively. Of all herniorrhaphies 798 (16%) were done for recurrences, 142 of these after operations between 1992 and 1994. At 24 months 4% of all operations had been redone because of recurrences with highly significant variations among hospitals ranging from 1.5% to 6.7%. Postoperative complications within 30 days after operation, direct hernia, recurrent hernia, and the use of absorbable sutures were associated with an increased risk of reoperation. CONCLUSIONS: A quality register recorded voluntarily can identify significant interhospital differences in outcome as well as variables associated with an increased risk of reoperation, thereby raising quality awareness and facilitating the process of improvement.

Heartburn without oesophagitis: efficacy of omeprazole therapy and features determining therapeutic response.

BACKGROUND: Data are limited on the value of effective antisecretory therapy in the relief of heartburn in patients without oesophagitis. METHODS: Patients with heartburn, without endoscopic signs of oesophagitis, were randomized to double-blind treatment with omeprazole, 20 or 10 mg once daily, or placebo, for 4 weeks (n = 509). Pre-treatment oesophageal acid exposure was assessed using 24-h intra-oesophageal pH monitoring. Heartburn was assessed at 2 and 4 weeks. RESULTS: At 4 weeks the proportion of patients with complete absence of heartburn was 46% (95% confidence interval, 39-53%) with 20 mg omeprazole, 31% (25-38%) with 10 mg omeprazole, and 13% (7-20%) with placebo. Satisfaction with therapy was reported by 66%, 57%, and 31% of the patients, respectively. CONCLUSION: Omeprazole, 20 and 10 mg once daily, provides rapid relief of heartburn in patients without endoscopic oesophagitis.

Preoperative local infiltration with ropivacaine for postoperative pain relief after inguinal hernia repair. A randomised controlled trial.

OBJECTIVE: To assess the effect of preoperative local anaesthesia with ropivacaine and find out if there was a dose-response relationship with postoperative pain after inguinal hernia repair. DESIGN: Randomised, double-blind, placebo-controlled trial. SETTING: Two Swedish and two Norwegian hospitals. SUBJECTS: 131 Male patients undergoing elective inguinal hernia repair. INTERVENTION: Infiltration of the inguinal field before operation with 0.5% ropivacaine 40 ml (200 mg), 0.25% ropivacaine 40 ml (100 mg) or saline 40 ml. MAIN OUTCOME MEASURES: Wound pain at rest and during mobilisation, pressure exerted to reach pain threshold and maximum pain tolerance after 3, 6, 10, and 24 hours, and after 7 days; consumption of analgesics; and Quality of Life assessed by two independent questionnaires before and after operation. RESULTS: Pain scores after 3 hours were significantly lower in the ropivacaine groups compared with the saline group for all variables (p < 0.05). At 6 hours pain scores were significantly lower for ropivacaine 0.5% compared with saline for wound pain during mobilisation and pressure exerted to reach maximum pain tolerance. Patients given saline made their first request for analgesics significantly sooner than in the other two groups (p < 0.05), and a significantly larger percentage of them requested analgesics during the first 24 hours (p < 0.05). Evaluation of the Quality of Life questionnaires showed no significant differences between the groups. CONCLUSION: Ropivacaine has a significant, dose-related pain-reducing effect in the immediate postoperative period but we could find no support for the theory that preoperative infiltration analgesia reduces long term pain.

Adjusting outcome measurements for case-mix in a vascular surgical register--is it possible and desirable?

OBJECTIVE: We analysed the variation in the outcome of infrainguinal bypass surgery between departments in a register for clinical audit to see if variation in case-mix influenced the results. MATERIALS AND METHODS: The study was a retrospective analysis of 764 infrainguinal bypass operations performed from 1988 to 1990 at six Swedish surgical departments. Results were assessed at 30 days and at 1 year postoperatively. RESULTS: There was a significant variation (p < 0.01) in mortality and amputation rates both at 30 days and at 1 year and in patency rate at 30 days. There were also differences in case-mix. Differences were found in indication, location of distal anastomosis and graft type. Regression analysis found that mortality was influenced by age, diabetes and heart disease and patency rate by location of the distal anastomosis and graft type. When 'hospital' was added as a variable in the regression analysis it was also found to be a significant indicator. CONCLUSION: Location of the distal anastomosis was the main factor in adjusting patency for case-mix.

Patients not included in medical audit have a worse outcome than those included.

The aim of the present investigation was to analyse a clinical database in order to see how many patients were not included in medical audit and to see whether the outcome of the non-registered patients differed from that of the registered patients. Two independent surgeons studied the records of all infrainguinal bypass operations performed at six vascular surgical departments over a three-year period. A total of 684 bypass operations was reported to the register, of which 636 could be reviewed. One-hundred and twenty-eight cases that had not been reported were found from other sources. The outcome variables were mortality, amputation rate and patency. Sixteen per cent of eligible cases had not been reported. Mortality and amputation rate were twice as high among the missing cases as among the reported cases. There was no difference in patency. Overall judgement of the performance of an individual department may be impaired by cases not included in the register.

The effect of cisapride and ranitidine as monotherapies and in combination in the treatment of uncomplicated gastric ulceration.

BACKGROUND: Stimulation of gastric motility has been supposed to accelerate the healing of gastric ulcer. The combination of the prokinetic drug cisapride and the H2 blocker ranitidine was tested in the treatment of uncomplicated gastric ulcer. METHODS: Cisapride, 20 mg twice daily (Cis), and ranitidine, 150 mg twice daily (Ran), were given as monotherapies and in the combination 20 mg cisapride and 150 mg ranitidine daily (Cis + Ran) for a maximum of 8 weeks. The study was multicentre, randomized, and double-blind. RESULTS: A total of 197 patients were included. Healing rates in the per-protocol analysis after 4 and 8 weeks' treatment were 61%/84%, 52%/69%, and 61%/92% for the Cis + Ran (n = 56), Cis (n = 58), and Ran (n = 59) treatment groups. No statistically significant difference in healing rates was seen when comparing Cis + Ran with the monotherapies. Symptom relief at the end of treatment was significantly better in the Ran group than in the Cis + Ran group with regard to epigastric pain (p = 0.01) and vomiting (p = 0.05). Patients' global evaluation of treatment was in favour of Ran in comparison with Cis + Ran treatment (p = 0.04). CONCLUSIONS: Combination of cisapride and ranitidine in the treatment of gastric ulcer did not enhance the healing rate or improve symptom relief in patients treated for uncomplicated gastric ulcer when compared with the monotherapies.

Retroperitoneal malignant cyst. Case report.

Forty years after removal of a benign mucinous cyst from the left retroperitoneal space, a malignant cyst with both sarcomatous and carcinomatous components was removed from the same site in a 75-year-old woman. Within 6 months the lesion recurred as a carcinoma penetrating the left colon and the abdominal wall.