Individual Complication Rates Research Articles

Metaanalysis of randomized controlled trials of endoscopic retrograde cholangiography and endoscopic sphincterotomy for the treatment of acute biliary pancreatitis

OBJECTIVE: Endoscopic retrograde cholangiography with endoscopic sphincterotomy (ERC+ES) has been advocated for the management of acute biliary pancreatitis. However, it is also viewed as dangerous. Our objective was to review published randomized, controlled trials (RCTs) of ERC+ES in patients with acute biliary pancreatitis and, by metaanalysis, to estimate the overall efficacy and safety of this approach. METHODS: We performed a fully recursive literature search for published RCTs of ERC+ES in gallstone-related acute pancreatitis. RCTs were pooled. Individual and overall mortality and complication rates were calculated, together with their 95% confidence intervals (CI), absolute risk reduction (ARR), relative risk reduction (RRR), and numbers needed to treat (NNT) for avoidance of complications or death. RESULTS: Four published RCTs had a numerically lower complication rate, and three had a numerically lower mortality rate, in the treated groups than in controls. After pooling, there were 460 treated patients and 374 controls. Complications occurred in 115 (25.0%) treated patients and 143 (38.2%) controls (z = 4.10; p < 0.001). Twenty-four treated patients (5.2%) and 34 controls (9.1%) died (z = 2.15; p < 0.05). ERC+ES had a 34.6% RRR for complications and a 42.9% RRR for death; ARR for complications and death was 13.2% (95% CI: 6.9–19.5%) and 3.9% (95% CI: 0.35–7.45%), respectively. The NNT for avoidance of complications and death was 7.6 and 25.6, respectively. CONCLUSIONS: ERC+ES reduces morbidity and mortality in patients with acute biliary pancreatitis. Treating 26 such patients with ERC+ES is predicted to save one life.

The use of heparin in patients in whom a pulmonary embolism is suspected after total hip arthroplasty.

The morbidity and mortality associated with pulmonary embolism are well known, as is the benefit of the use of heparin in patients who have a pulmonary embolism. However, the patterns of heparin use as well as its undesirable effects, especially in patients who have recently had a total hip arthroplasty, have been less well studied. Thus, concern arises regarding the use of heparin in patients who have no firm evidence of a pulmonary embolism. The purpose of the current study was to track the use of heparin and associated orthopaedic complications in patients in whom a pulmonary embolism was suspected after a total hip arthroplasty. The records of 150 patients in whom a pulmonary embolism had been suspected after a total hip arthroplasty were reviewed retrospectively. The rates of individual complications (such as stroke, infection, and hematoma) and those of groups of complications (such as medical complications, orthopaedic complications, and all complications combined) were recorded and then were stratified according to the treatment (with or without heparin), the presence or absence of pulmonary embolism, and other variables. Thirty-two (47 percent) of sixty-eight patients who were managed with heparin had complications compared with sixteen (20 percent) of eighty-two patients who were not thus managed (p = 0.0006). Specifically, patients who were managed with heparin were more likely to have gastrointestinal bleeding, hematological complications, a loose prosthesis, a hematoma, or an early revision arthroplasty (p<0.05 for all). With the numbers available, the use of heparin was not found to be significantly associated with an increased risk of death, stroke, or infection at the site of the prosthesis. Interestingly, thirty-one (31 percent) of ninety-nine patients who had ventilation-perfusion scans that demonstrated normal findings or findings indicating a low probability of pulmonary embolism were given heparin before the diagnosis of a pulmonary embolism was excluded, and sixteen (52 percent) of these thirty-one had complications. Given this risk profile, we advise against the use of heparin before the diagnosis of pulmonary embolism is established in patients who have had a total hip arthroplasty. This recommendation is supported by algorithms, in widely read medical texts, pertaining to the use of heparin in patients in whom a pulmonary embolism is suspected.

Assessment of Complication Types and Rates Related to Diagnostic Angiography and Interventional Neuroradiologic Procedures

We determined the types and rates of complications related to diagnostic angiography and neuroradiologic interventional procedures at a centre that carries out the full spectrum of angiographic procedures. The occurrence of immediate and delayed complications in 1929 neuroangiographic procedures (1358 diagnostic and 571 interventional) performed between the years 1993-1996 was prospectively identified and recorded on a daily basis. A retrospective review of all charts of patients having procedures conducted during the study period was also carried out to ensure that no complications were missed. The overall complication rate for diagnostic cerebral angiography was 2.2%. Puncture site complications ranged from 0 - 0.1 %. Vessel injury distal to the puncture site ranged from 0.2 - 0.6%. The temporary neurologic complication rate was 0.3%, while the permanent rate was 0.4%. There were no contrast reactions. The death rate was 0.1 %. Interventional procedures had higher incidences of complications with overall rates ranging from 5.3 - 33%. Temporary and permanent neurologic deficits occurred at a rate of 0 - 10.5% depending upon the procedure involved. Individual complication and death rates and complication categories are provided for arteriovenous malformation embolisation, tumour embolisation, temporary balloon occlusion tests, detachable balloon vessel sacrifice, urokinase infusion, angioplasty, papavarine infusion, GDC embolisation, and carotid cavernous fistula embolisation. When carried out in experienced hands, neuroangiography and neurointervention are relatively safe with low incidences of neurologic and non-neurologic complications. Knowledge of these rates is important when counselling patients prior to treatments or deciding upon the risk-benefit ratio of preoperative procedures.

Total Versus Subtotal Thyroidectomy: Arguments, Approaches, and Recommendations

Arguments for routine total thyroidectomy or routine, less than total resection have been espoused for treatment of well-differentiated intrathyroidal carcinoma. Numerous reports in the literature support either approach. No prospective randomized studies have been performed, partly because of the indolent nature of the disease. Many reports are also complicated by the failure of the authors to divide patients into high-risk and low-risk groups and to categorize and evaluate fully the histologic types of the resected tumors. Good evidence exists to show that in the majority of cases of intrathyroidal, well-differentiated lesions, bilateral subtotal resection yields results that compare favorably with total thyroidectomy. Logically, at least, a total thyroidectomy would seem to be preferable, because subtotal resection can be imprecise. Therefore, subtotal thyroidectomy can be recommended over total thyroidectomy, if only on the basis of comparison of complications. The type and rate of complications vary among surgeons. Each thyroid surgeon, therefore, must establish an individual complication rate. Total thyroidectomy in inexperienced hands is not recommended. We recommend, therefore, that total thyroidectomy be used selectively by surgeons who have the skill and experience necessary to make the decision intraoperatively. If, for example, during resection of the lobe that contains the primary tumor, the laryngeal nerves and parathyroid glands can be clearly identified and if there is minimal bleeding and trauma, the surgeon may proceed to side two to perform a total thyroidectomy. If the lesion is large, however, with distortion of anatomy, dissection may be difficult even for an experienced surgeon. Intracapsular parathyroids or undiscovered parathyroids on the side of initial resection should prompt the surgeon to perform a subtotal resection on side two. Under these circumstances, the surgeon should not feel that a total thyroidectomy justifies the increased risk. A unilateral resection, such as lobectomy plus isthmusectomy, can be performed with satisfactory long-term results in low-risk patients, that is, in those with small (less than 1.5 cm) unilateral intrathyroidal exposure and in those with no evidence of metastatic disease. Alternately, the AGES criteria of Hay et al can be used to identify patients in low- or high-risk groups. If the decision to perform a bilateral resection is based on the previous criteria, we recommend that a total thyroidectomy be performed only by an experienced surgeon. During surgery, if there is any suggestion that the laryngeal nerves or parathyroid glands would be at increased risk if a total resection were performed, it may be necessary to revert to a subtotal procedure.(ABSTRACT TRUNCATED AT 400 WORDS)

Risikoeinschätzung und Vorbehandlung bei Ösophaguskarzinom-Patienten

In 36 patients who underwent surgery for carcinoma of the oesophagus (21 patients subjected to blunt mediastinal dissection, 15 to thoracotomy) the preoperative status was determined by means of cardiopulmonary stepwise diagnosis and an individually adapted concomitant therapy was performed. A scheme for preoperative risk assessment which is equally important for both methods was evolved from the postoperative changes of VC, FEV1 and the preoperative values for RV/TLC, FEV1/VC, paO2 and paCO2 after retrospective analysis of the individual complication rates (60% cardiopulmonary). The 30-day lethality was 11%.