Morten Vetrhus

Pain persists in many patients five years after removal of the gallbladder: Observations from two randomized controlled trials of symptomatic, noncomplicated gallstone disease and acute cholecystitis

After removal of the gallbladder, pain may persist in some patients. To study this condition, 124 patients from two randomized trials, including those with symptomatic noncomplicated gallbladder stones (n = 90) and acute cholecystitis (n =34), were interviewed, while 139 patients (90%) excluded from both trials responded to a questionnaire 5 years after the operation. Thirty-four patients (27%) of those randomized had pain; 23 (18%) had diffuse, steady pain; and 11 (9%) had pain attacks resembling their preoperative symptoms.Asignificant dominance of diffuse pain occurred inwomen(P = 0.024), especially those younger than 60 years (P = 0.004). A tendency for the diffuse type to be dominant was also present in the group of female patients with symptomatic noncomplicated gallbladder stones (P = 0.052). Of the excluded patients, 18% (25/139) had pain, but 88% of them (96% of the men and 87% of the women) were satisfied with the result of the operation. The overall number of patients with postoperative pain was 22% (59/263). We conclude that persisting abdominal pain 5 years after the operation was mainly of a nonspecific type, found mostly in younger women who had had noncomplicated gallstone disease. Eightyeight percent of the excluded patients declared themselves satisfied with the result of cholecystectomy.

Acute Cholecystitis: Delayed Surgery or Observation. A Randomized Clinical Trial

BACKGROUND The aim of the present study was to compare the risk of observation versus that of cholecystectomy in acute cholecystitis in patients randomly allocated to delayed operation or conservative treatment. METHODS One-hundred-and-eighty patients were considered for participation in the study; 71 were excluded according to predefined criteria and 45 did not join for other reasons. The remaining 64 patients were randomized to cholecystectomy (n = 31) or observation (n = 33). Randomized patients were contacted regularly and followed up for a median of 67 months. All gallstone-related hospital contacts were registered in both randomized and excluded patients. RESULTS Gallstone-related complications or emergency admissions for pain occurred in six patients in the operation group (19%; 95% CI 5%-33%) and in 12 patients (36%; 9% CI 20%-53%) in the observation group. Twenty-seven of 31 patients randomized to cholecystectomy had a cholecystectomy at a median of 3.6 months after randomization, and, of these, 3 (11%; 95% CI 0%-23%) suffered a major and 7 (26%; 95% CI 9%-42%) a minor complication. Ten patients randomized to observation later had their gallbladders removed, 1 (10%; 95% CI 0%-29%) patient had a major and 1 (10%; 95% CI 0%-29%) a minor complication. We found no mortality after cholecystectomy. CONCLUSIONS We found a certain risk of subsequent gallstone-related events following conservative treatment of acute cholecystitis, but the data also show that cholecystectomy should not necessarily be compulsory after acute cholecystitis.Background: The aim of the present study was to compare the risk of observation versus that of cholecystectomy in acute cholecystitis in patients randomly allocated to delayed operation or conservative treatment. Methods: One-hundred-and-eighty patients were considered for participation in the study; 71 were excluded according to predefined criteria and 45 did not join for other reasons. The remaining 64 patients were randomized to cholecystectomy ( n r = r 31) or observation ( n r = r 33). Randomized patients were contacted regularly and followed up for a median of 67 months. All gallstone-related hospital contacts were registered in both randomized and excluded patients. Results: Gallstone-related complications or emergency admissions for pain occurred in six patients in the operation group (19%; 95% CI 5%-33%) and in 12 patients (36%; 9% CI 20%-53%) in the observation group. Twenty-seven of 31 patients randomized to cholecystectomy had a cholecystectomy at a median of 3.6 months after randomization, and, of these, 3 (11%; 95% CI 0%-23%) suffered a major and 7 (26%; 95% CI 9%-42%) a minor complication. Ten patients randomized to observation later had their gallbladders removed, 1 (10%; 95% CI 0%-29%) patient had a major and 1 (10%; 95% CI 0%-29%) a minor complication. We found no mortality after cholecystectomy. Conclusions: We found a certain risk of subsequent gallstone-related events following conservative treatment of acute cholecystitis, but the data also show that cholecystectomy should not necessarily be compulsory after acute cholecystitis.

Liver and Biliary Tract Symptomatic, Non-Complicated Gallbladder Stone Disease. Operation or Observation?

BACKGROUND Cholecystectomy has been recognized as the treatment of choice for symptomatic gallbladder stone disease. Not all patients are cured by an operation and the reason for having the gallbladder removed may rest on common practice rather than evidence-based medicine. The aim was to compare cholecystectomy with observation (watchful waiting) in patients with uncomplicated symptomatic GBS disease. Three-hundred-and-thirty-eight patients were considered for participation in the study; 45 patients were excluded according to predefined criteria and 156 did not join for other reasons. The remaining 137 were randomized to cholecystectomy (n = 68) or non-operative, expectant treatment (n = 69). METHODS Randomized patients were contacted regularly and followed for a median of 67 months. All gallstone-related hospital contacts were registered in both randomized and excluded patients. RESULTS Eight of the patients randomized to cholecystectomy did not undergo operation, while 35 of the patients randomized to observation later had their gallbladders removed. The cumulative risk of having a cholecystectomy seemed to level off after 4 years. Gallstone-related complications occurred in 3 patients in the observation group, 1 in the operation group and 5 of 201 excluded patients. After cholecystectomy, 16 of 222 patients had a major complication and 10 a minor. CONCLUSIONS We found that non-operative expectant treatment carries a low risk of complications. Patients should be informed that watchful waiting is a safe option.Background: Cholecystectomy has been recognized as the treatment of choice for symptomatic gallbladder stone disease. Not all patients are cured by an operation and the reason for having the gallbladder removed may rest on common practice rather than evidence-based medicine. The aim was to compare cholecystectomy with observation (watchful waiting) in patients with uncomplicated symptomatic GBS disease. Three-hundred-and-thirty-eight patients were considered for participation in the study; 45 patients were excluded according to predefined criteria and 156 did not join for other reasons. The remaining 137 were randomized to cholecystectomy ( n = 68) or non-operative, expectant treatment ( n = 69). Methods: Randomized patients were contacted regularly and followed for a median of 67 months. All gallstone-related hospital contacts were registered in both randomized and excluded patients. Results: Eight of the patients randomized to cholecystectomy did not undergo operation, while 35 of the patients randomized to observation later had their gallbladders removed. The cumulative risk of having a cholecystectomy seemed to level off after 4 years. Gallstone-related complications occurred in 3 patients in the observation group, 1 in the operation group and 5 of 201 excluded patients. After cholecystectomy, 16 of 222 patients had a major complication and 10 a minor. Conclusions: We found that non-operative expectant treatment carries a low risk of complications. Patients should be informed that watchful waiting is a safe option.

Pain and quality of life in patients with symptomatic, non-complicated gallbladder stones: results of a randomized controlled trial.

Background: Cholecystectomy is intended to relieve symptoms of gallstones, but unfortunately some patients will experience postcholecystectomy symptoms, including pain. There is limited information in the literature on gallstone‐related pain and its influence on quality of life. The aim of this study was to examine how pain and quality of life in patients with symptomatic, uncomplicated gallbladder stones were affected by observation of their condition compared with removal of the gallbladder. Methods: One‐hundred and thirty‐seven patients were randomized to observation (watchful waiting; n = 69) or cholecystectomy (n = 68) and answered questionnaires on pain, quality of life (PGWB index and NHP Part II) at randomization and fixed intervals (6, 12 and 60 months). All gallstone‐related events (hospital admission for pain, complications of gallstone disease and cholecystectomy) and crossover between treatment groups were recorded. Results: Of patients randomized to observation, 35 of 69 patients (51%) eventually underwent a cholecystectomy. Significant improvements in quality of life and pain scores were detected regardless of surgical treatment. Patients that subsequently experienced gallstone‐related events had significantly higher pain scores at randomization than patients that did not experience any subsequent events, and this difference was maintained throughout follow‐up. Conclusions: Unexpectedly, in the majority of patients symptoms did abate without any significant differences between groups in pain and quality of life. Patients that had high intensity and frequency of pain at randomization had a higher risk of experiencing subsequent events.

Pain attacks in non-complicated and complicated gallstone disease have a characteristic pattern and are accompanied by dyspepsia in most patients: The results of a prospective study

Objective. The cardinal indication for surgical treatment of gallstones is pain attacks. However, following cholecystectomy, 20% of patients remain symptomatic. It is unclear to what extent post-cholecystectomy symptoms can be ascribed to persistence of preoperative symptoms or to new pathology. The pain and digestive pattern in gallstone patients has not been defined in a recent setting with ultrasonography as the diagnostic method. The aim of this study was to characterize a pain pattern that is typical for gallstone disease and to describe the extent of associated dyspepsia. Material and methods. A total of 220 patients with symptomatic gallstone disease including complicated disease (acute cholecystitis and common bile duct stones) were interviewed using detailed questionnaires to disclose pain patterns and symptoms of indigestion. Results. All patients had pain in the right upper quadrant (RUQ) including the upper midline epigastrium. The pain was localized to the right subcostal area in 20% and to the upper epigastrium in 14%, and in the rest (66%) it was more evenly distributed. An area of maximal pain could be defined in 90%. Maximal pain was located under the costal arch in 51% of patients and in the epigastrium in 41%, but in 3% behind the sternum and in 5% in the back. The pain was referred to the back in 63% of the patients. The mean visual analogue scale (VAS) score was very high: 90 mm on a 0–100 scale. A pattern of incipient or low-grade warning pain with a subsequent relatively steady state until subsiding in the same fashion was present in 90% of the patients. An urge to walk around was experienced by 71%. Pain attacks usually occurred in the late evening or at night (77%), with 85% of the attacks lasting for more than one hour and almost never less than half an hour. Sixty-six percent of the patients were intolerant to at least one kind of food, but only 48% to fatty foods. Symptoms of functional indigestion (gastroesophageal reflux, dyspepsia or irritable bowel symptoms) were seen in the vast majority in association with attacks. Conclusions. Gallstone-associated pain follows a certain pattern in the majority of patients. The pain is located in a defined area with a point of maximum intensity, is usually referred, and occurs mainly at night with duration of more than one hour. The majority of patients experience functional indigestion, mainly of the reflux type or dyspepsia.

Efficacy of a two-tiered trauma team activation protocol in a Norwegian trauma centre

A registry‐based analysis revealed imprecise informal one‐tiered trauma team activation (TTA) in a primary trauma centre. A two‐tiered TTA protocol was introduced and analysed to examine its impact on triage precision and resource utilization.

Long-term follow-up of a randomized controlled trial of observation versus surgery for acute cholecystitis: Non-operative management is an option in some patients

Abstract Background. Cholecystectomy is routinely recommended to prevent recurrent disease after an initial episode of acute cholecystitis. Therefore, randomized controlled trials have mainly focused on the timing of surgery, but many patients scheduled for cholecystectomy have deferred surgery with long periods of symptom-free intervals. Our present aim is to examine the long-term feasibility and safety of observation compared with surgery. Methods. Trial of 64 patients with acute cholecystitis previously randomized to observation or cholecystectomy, which examined outcome in terms of completed randomized treatment and appearance of further symptoms and the need for surgical treatment. Thirty-three patients were randomized to observation and 31 patients to cholecystectomy. Median follow-up was 14 years. Results. Of the 33 patients randomized to observation, 11 (33%) experienced a new event of gallstone-related disease (eight (24.2%) had acute cholecystitis) and 11 (33%) were operated. No significant difference (p = 0.565) was found between the two randomized groups with regard to recurrent disease or complications. Virtually no surgery took place after 5 years of follow-up. The difference in completed randomized treatment between the groups was not significant (p = 0.077). Long-term mortality was equal in those operated and in those observed. Conclusions. Twenty-four percent of the patients experienced recurrent cholecystitis, but escalation of disease severity or increased mortality was not observed. Long-term observation after acute cholecystitis was feasible in two-thirds of the patients as the risk for recurrent disease was negligible after 5 years.

Endoscopic sphincterotomy in acute gallstone pancreatitis: a prospective study of the late outcome

OBJECTIVE To describe the outcome after acute biliary pancreatitis in patients treated during the acute attack by endoscopic sphincterotomy without cholecystectomy. DESIGN Prospective observational study. SETTING University hospital, Norway. SUBJECTS 130 patients with gallstones and acute pancreatitis. In 62 patients with common bile duct stones the bile duct was cleared by sphincterotomy and stone extraction. The remaining 68 patients had prophylactic sphincterotomy. Cholecystectomy was not planned later. MAIN OUTCOME MEASURES Incidence of recurrent acute pancreatitis and need for cholecystectomy. RESULTS 21 patients were dead or not available for the follow-up. Consequently 109 patients were followed-up for a median of 39 months (range 23-62). One patient had recurrent pancreatitis. 20 patients had a cholecystectomy later for symptoms related to gallstone disease. Of the rest, 25 patients had moderate or mild gallstone-related symptoms. There was no difference in gallstone-related symptoms between those who had had stones in the bile duct and those who had not. 63 patients had no symptoms related to gallstones. CONCLUSION Endoscopic sphincterotomy during or immediately after acute gallstone pancreatitis resulted in half the patients being free of symptoms during the next three years.

Epidemiology of ruptured abdominal aortic aneurysms in a well-defined Norwegian population with trends in incidence, intervention rate, and mortality

OBJECTIVE Ruptured infrarenal abdominal aortic aneurysms (rAAAs) represent both a life-threatening emergency for the affected patient and a considerable health burden globally. The aim of this study was to investigate the contemporary epidemiology of rAAA in a defined Norwegian population for which both hospital and autopsy data were available. METHODS This was a retrospective, single-center population-based study of rAAA. The study includes all consecutively diagnosed prehospital and in-hospital cases of rAAA in the catchment area of Stavanger University Hospital between January 2000 and December 2012. Incidence and mortality rates (crude and adjusted) were calculated using national demographic data. RESULTS A total of 216 patients with primary rAAA were identified. The adjusted incidence rate for the study period was 11.0 per 100,000 per year (95% confidence interval [CI], 9.6-12.5). Twenty patients died out of the hospital, and 144 of the 196 patients (73%) admitted to the hospital underwent surgery. The intervention rate varied from 48% to 81% during the study period. The adjusted mortality rate was 7.5 per 100,000 per year (95% CI, 6.3-8.8). No differences in the incidence and mortality rates were found in comparing early and late periods. The 90-day standardized mortality ratio for the study period was 37.2 (95% CI, 31.6-43.7). The overall 90-day mortality was 68% (146 of 216 persons) and 51% (74 of 144 persons) for the patients treated for rAAA. CONCLUSIONS We found a stable incidence and mortality rate during a decade. The prehospital death rate was lower (9%), the intervention rate (73%) higher, and the total mortality (68%) lower than in most other studies. Geographic and regional differences may influence the epidemiologic description of rAAA and hence should be taken into consideration in comparing outcomes for in-hospital mortality and intervention rates.

A Randomized Controlled Study of Uncomplicated Gallstone Disease with a 14-Year Follow-Up Showed that Operation Was the Preferred Treatment

Background/Aims: Cholecystectomy is considered the treatment of choice for symptomatic gallstone disease. Some patients abstain from surgery and provide the opportunity to study the natural history of cholelithiasis. The aim of the present study was to examine the feasibility and safety of observation after extended long-term follow-up in a randomized controlled trial. Methods: A total of 137 patients (40.5% of those assessed) were randomized to observation or cholecystectomy and followed up for 14 years. The prevalence of symptomatic events or major complications after treatment was the primary end point. A secondary end point was completion of randomized treatment. Results: There were no differences in outcome between the observation group and the surgical group (p = 0.298). Virtually no cholecystectomy was performed after 5 years of follow-up, and no clear escalation in the severity of the disease was observed. A total of 50.7% of patients from the observation group and 88.2% from the surgical group underwent surgery. The group randomized to surgery completed their designated treatment significantly more often (p < 0.001), especially among patients younger than 70 years of age (p = 0.005). Conclusion: Cholecystectomy was the preferred treatment after extended long-term follow-up, but conservative management for symptomatic gallstone disease is an alternative to surgery in the elderly.