Immediate definitive surgery for perforated duodenal ulcer does not increase operative mortality: A prospective controlled trial

One hundred and sixty-two patients with nonsealed perforated duodenal ulcer have been studied prospectively. These patients were randomized to undergo simple closure (83 patients) or closure and vagotomy (79 patients); the vagotomy was either a truncal vagotomy (71 patients) or a proximal gastric vagotomy (8 patients). One operative death was recorded in the simple closure group, that of a 92-year-old woman operated 36 hours after the onset of perforation, who died on the seventh postoperative day of infectious pulmonary complications. There were no deaths in the vagotomy group. The mortality in the 2 groups, simple closure and vagotomy, can be assumed to be similar according to a decision-making rule based on confidence interval limits (p<0.05). Complications and postoperative course were similar in both groups except for wound infection, which was more frequent in the vagotomy group than in the simple closure group (p<0.05). Two previous prospective clinical trials have shown that relief of symptoms was better in the group treated by definitive surgery than in the control group treated by simple closure. Demonstration of similar mortality rates in simple closure and vagotomy groups failed in these 2 trials because of a high type II error. We conclude therefore, that because of equal postoperative mortality (p<0.05) and better long-term results, definitive surgery is better than simple closure in the treatment of nonsealed perforated duodenal ulcer.

---

Resumen Ciento sesenta y dos pacientes con úlcera duodenal perforada y no autosellada han sido estudiados en forma prospectiva. Estos pacientes fueron randomizados para recibir cierre simple de la perforación (83 pacientes) o cierre y vagotomía (79 pacientes); la vagotomía fue troncular en 71 pacientes y gástrica proximal en 8 pacientes. Se presentó una muerte en el grupo de cierre simple, la de una mujer de 92 años operada a las 36 horas de ocurrida la perforación, quien falleció en el séptimo día por complicaciones sépticas pulmonares. No hubo muertes en el grupo de las vagotomías. Se puede asumir que la mortalidad es similar en los 2 grupos, cierre simple y vagotomía, de acuerdo con el análisis estadístico (p<0.05). La incidencia de complicaciones y la evolución postoperatoria fueron similares en los 2 grupos, a excepción de la tasa de infectión de herida que fue mayor en el grupo de vagotomía que en el grupo de cierre simple (p<0.05). Dos ensayos clínicos prospectivos anteriores han demostrado que el control de los síntomas es superior en los pacientes tratados con cirugía definitiva que en los pacientes tratados con cierre simple. La demostración de similares tasas de mortalidad en los grupos de cierre simple y de vagotomía resultó fallida en estos 2 ensayos clínicos debido a un elevado riesgo de error tipo II en una muestra de tan reducido tamaño. En consecuencia, nuestra conclusión es que en virtud de igual tasa de mortalidad postoperatoria (p<0.05) y mejores resultados a largo plazo, la cirugía definitiva es superior al cierre simple en el tratamiento de la úlcera duodenal perforada y no autosellada.

---

Résumé Cent soixante deux patients ayant une perforation d'ulcère duodénal non couverte ont été étudiés prospectivement. Après randomisation, ces patients ont été repartis en 2 groupes: les patients du groupe I (N=83) ont subi une fermeture simple, ceux du groupe II (N=79), une vagotomie associée. La vagotomie était tronculaire chez 71 patients et suprasélective chez 8 patients. Il y a eu une seule mort dans le groupe I: il s'agissait d'une femme opérée 36 heures après la perforation, et décédée au 7ème jour postopératoire de complications pulmonaires infectieuses. Il n'y a pas eu de mortalité dans le groupe II (vagotomie). La mortalité dans chacun des 2 groupes peut être présumée égale selon une règle basée sur les intervalles de confiance (p<0.05). Le taux des complications, excepté l'infection pariétale, plus fréquente dans le groupe II que dans le groupe I, et l'évolution postopératoire étaient les mêmes dans les 2 groupes. Deux études prospectives déjà publiées ont démontré que la chirurgie définitive améliorait de façon significative la symptomatologie par rapport à la fermeture simple. Cependant, il n'a pas été possible de démontrer que la mortalité des 2 groupes était similaire en raison d'une erreur du type II trop importante. Nous concluons que puisque la mortalité postopératoire est égale avecp<0.05, et les résultats meilleurs, la chirurgie définitive est meilleure que la fermeture simple dans le traitement en urgence de la perforation en péritoine libre d'ulcère duodénal.

---

---

Members of the Association for Surgical Research who have participated in the study are: Jean-Louis Bernard, M.D., François Dazza, M.D., Jean-François Delalande, M.D., Bernard Descottes, M.D., François Desmaizieres, M.D., Gérard Desvignes, M.D., André Elhadad, M.D., Jacques Emer, M.D., Pierre-Louis Fagniez, M.D., Yves Flamant, M.D., Serge Hannoun, M.D., Henri Hennet, M.D., Daniel Keller, M.D., Patrice Laigneau, M.D., François Lemoine, M.D., Pierre Meyer, M.D., Xavier Pouliquen, M.D., François Poulton, M.D., Michel Rodary, M.D., Nelly Rotman, M.D., François Rouffet, M.D., Jean-Louis Sicard, M.D., and Christian Thomsen, M.D.     

Local 133xenon clearance in the eye and comparative in vitro wash-out time determination in patients with monoclonal gammopathy]

The authors investigated the dependence of the local clearance of 133xenon to the viscosity of the blood. Increase of viscosity of blood compared with decrease of local clearance of 133xenon by patients with monoclonal gammopathy were demonstrated. It was also shown that using the Beta-part of radiation of 133xenon is sufficient for looking for wash-out-times of the anterior eye segment. However, use of 133xenon in isotonic solution is also possible in other ophthalmological diseases for differentiation.     

Hyperlipidemia, hypercoagulability, and accelerated thrombosis: studies in congenitally hyperlipidemic rats and in rats and monkeys with induced hyperlipidemia

Inbred Carworth Farms Nelson (CFN) congenitally hyperlipidemic rats had significantly shorter coagulation and prothrombin times and higher levels of coagulation factors, II, V, VII, VIII, and X than did controls. Conversely, congenitally hypolipidemic rats of the same strain had significantly longer coagulation and prothrombin times and lower levels of factors II, V, VII, X and XII and of blood platelets than did controls. A loop-shaped polyethylene cannula was inserted into the aorta to assess the potential for thrombosis. The hyperlipidemic group obstructed this significantly faster and the hypolipidemic group slower than did the controls. Normal CFN rats made hypertensive by unilateral renal artery clip developed hypertension together with significantly elevated serum cholesterol and factor VII and X levels. Rhesus monkeys with diet-induced hyperlipidemia showed shorter prothrombin times and higher factor X levels than did controls on normal diet. By selective breeding, two groups of squirrel monkeys were obtained. Both groups had similar serum cholesterol levels on a normal diet but one group (hyperresponders) showed higher serum cholesterol levels on a cholesterol-containing diet than did the other (hyporesponder) group. Both groups showed significantly elevated levels of factors II, V, VII, IX and X on a cholesterol-containing diet. There was good correlation between the levels of many coagulation factors and serum cholesterol in both rats and monkeys. If thrombosis is important in the genesis of atherosclerosis, these findings could indicate that elevation of plasma lipids may play a role, via the coagulation pathway, in the production of human vascular disease.     

Sodium chloride-induced partial inhibition in vivo of alpha 2-adrenoceptor agonist function

Recent research has demonstrated that sodium diminishes the affinity of alpha 2-adrenoceptors for agonists in vitro. Clonidine, a highly specific agonist for alpha 2-receptors, has a transient hypertensive effect when administered parenterally. We studied in conscious anephric Wistar rats the effect of equimolar saline or mannitol solutions on the hypertensive response to clonidine administered subcutaneously in doses of 10, 100 and 1000 micrograms/kg body weight. Prior saline infusion reduced the hypertensive response to the two higher doses of clonidine by 65 and 70%, and displaced the slope of the dose-response curve downwards, but mannitol had no such effect. Pre-treatment with the alpha 2-antagonist yohimbine abolished the differences in clonidine-induced pressor response between saline-treated, mannitol-treated and control rats. On the contrary, after pre-treatment with the alpha 1-antagonist prazosin, the pressor action of clonidine was significantly reduced in the saline-infused rats compared to the other two groups. Thus the saline-induced blunting of the pressor response elicited by clonidine could be negated by prior alpha 2- but not alpha 1-blockade, indicating that sodium interfered with the stimulation of post-synaptic vascular alpha 2-adrenoceptors. These findings indicate that loading with sodium chloride attenuates the alpha 2-adrenoceptor function in vivo. Based on this, we suggest that the mechanism by which sodium excess causes a rise in blood pressure involves modification of the alpha 2-adrenoceptors.